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Orrell M, Hoe J, Charlesworth G, et al. Support at Home: Interventions to Enhance Life in Dementia (SHIELD) – evidence, development and evaluation of complex interventions. Southampton (UK): NIHR Journals Library; 2017 Feb. (Programme Grants for Applied Research, No. 5.5.)

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Support at Home: Interventions to Enhance Life in Dementia (SHIELD) – evidence, development and evaluation of complex interventions.

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Chapter 2Maintenance cognitive stimulation therapy

Background

Cognitive ‘training’, cognitive ‘stimulation’ and cognitive ‘rehabilitation’ have on occasion been used almost interchangeably, but Clare and Woods42 have proposed clear definitions for all of these terms. Cognitive stimulation has been defined as the engagement in a range of activities and discussions (usually in a group) aimed at the general enhancement of cognitive and social functioning.42 CST6 is a therapeutic non-pharmacological treatment for dementia that aims to optimise cognitive function based on the notion of cerebral plasticity. A large multicentre RCT of CST found that it improved cognition and quality of life,6 and was cost-effective.13 Indeed, the 2007 draft NICE/Social Care Institute for Excellence guideline on dementia14 recommended that all people with mild-to-moderate dementia should have the opportunity to take part in a structured programme of cognitive stimulation groups.

As CST is only a brief intervention (a 14-session programme over 7 weeks), it is necessary to investigate if its benefits can be extended over a longer period of time. This has been investigated as a pilot study43 in which the 16 additional weekly sessions led to a significant improvement in cognitive function for those receiving MCST, compared with those receiving CST only. The programme grant funded a full-scale trial of MCST over 24 weeks.

The MSCT programme included an update of the Cochrane review on reality orientation/cognitive stimulation, explored the long-term effects of a MCST programme versus CST for dementia and compared the effectiveness of two different training approaches with care staff from a range of dementia care settings. The cognitive stimulation groups for people with dementia aimed to improve cognition and quality of life. The training package comprises a workbook, a digital versatile disc (DVD) and training seminars.

Work package 1: update of the Cochrane review on cognitive stimulation therapy

A systematic review and meta-analysis evaluating the effectiveness and impact of cognitive stimulation in dementia

A systematic review and meta-analysis evaluating the effectiveness and impact of cognitive stimulation in dementia was conducted with the Cochrane Dementia and Cognitive Improvement Group (CDCIG), based in Oxford, UK.44 The review followed the Specialised Register of the CDCIG, called ALOIS (Action in Language, Organisations and Information Systems). This yielded 94 studies, of which 15 were RCTs meeting the inclusion criteria. The analysis included 718 participants (407 receiving cognitive stimulation and 311 in control groups).

Objectives

  • To evaluate the effectiveness and impact of cognitive stimulation interventions aimed at improving cognition for people with dementia, including any negative effects.
  • To indicate the nature and quality of the evidence available on this topic.
  • To assist in establishing the appropriateness of offering cognitive stimulation interventions to people with dementia and identifying the factors associated with their efficacy.

Review methods

Protocol and registration

The protocol was registered with The Cochrane Library and can be found online at http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD005562.pub2/pdf.

Criteria for considering studies for this review

We selected RCTs examining the effect of cognitive stimulation for dementia if they had been published and written in English, peer reviewed and presented in a journal article. Authors were contacted for missing data, such as details of randomisation, means and standard deviations (SDs).

Search methods for identification of studies

The search methods included a combination of the search terms cognitive stimulation, reality orientation, memory therapy, memory groups, memory support, memory stimulation, global stimulation and cognitive psychostimulation, which were used to search ALOIS on 6 December 2011. The studies were identified from the following databases:

  • health-care databases: MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO and Latin American and Caribbean Health Sciences Literature (LILACS)
  • trial registers: metaRegister of Controlled Trials, Umin (University Hospital Medical Information Network) Japan Trial Register and World Health Organization portal [which covers ClinicalTrials.gov, International Standard Randomised Controlled Trial Number (ISRCTN), Chinese Clinical Trials Register, German Clinical Trials Register, Iranian Registry of Clinical Trials and the Netherlands National Trials Register, plus others]
  • The Cochrane Library’s Central Register of Controlled Trials
  • a number of grey literature sources: ISI Web of Knowledge Conference Proceedings, Index to Theses, Australasian Digital Theses.

Additional searches in each of the sources listed above to cover the time frame from the last searches performed for the Specialised Register to December 2011 were run to ensure that the search for the review was as up to date as possible. A total of 670 references were retrieved from the December 2011 update search. After deduplication and a first assessment, authors were left with 94 references to further assess for inclusion, exclusion or discarding.

Participants

Participants were any age with a diagnosis of dementia (Alzheimer’s disease, vascular dementia or mixed Alzheimer’s and vascular dementia, other types of dementia), including all severity levels of dementia, indicated through group mean scores, range of scores or individual scores on a standardised scale, such as the Mini-Mental State Examination (MMSE)45 or Clinical Dementia Rating (CDR).46 The participants could receive the intervention in a variety of settings (own home, outpatient setting, day care setting or residential setting). We documented when participants were receiving concurrent treatment with acetylcholinesterase inhibitors (AChEIs).

Interventions

Participants attended regular therapy sessions (involving a group or family caregiver) for a minimum period of 4 weeks. The intervention needed to describe a cognitive stimulation intervention targeting cognitive and social functioning, offering generalised cognitive practice. These may also be described as reality orientation groups, sessions or classes. The intervention needed to be compared with ‘no treatment’, ‘standard treatment’ or placebo.

Outcome measures

These assessed the short- (immediately after the intervention) and medium-term (follow-up 1 month to 1 year after the intervention finished) impact on the intervention on the person with dementia, the family caregiver or both. For the person with dementia, outcome measures needed to evaluate performance on at least one cognitive measure and/or include the assessment of any of the following variables: mood, well-being, activities of daily living (ADLs), behaviour, neuropsychiatric symptoms and social engagement. Rates of attrition and reasons for withdrawal were noted. Family caregiver outcomes, such as self-reported well-being, depression and anxiety, burden, strain and coping, and satisfaction with the intervention, were considered.

Data collection and analysis

Searches were conducted as detailed above to identify all relevant published studies. The date and time of each search, together with details of the version of the database used, were recorded. Additional information was sought, as outlined above, and hard copies of articles were obtained.

Quality assessment

Two reviewers independently screened the identified RCTs for inclusion and the final list of included studies was reached by consensus. Trials not meeting the criteria were excluded. The studies were assessed against a checklist of quality requirements using the Cochrane approach:

  • grade A – ‘low risk’: adequate concealment (randomisation; concealed allocation)
  • grade B – ‘unclear risk’: ‘randomised’, but methods uncertain
  • grade C – ‘high risk’: inadequate concealment of allocation or no randomisation, or both.

Only trials with a grade A or B ranking were included in the review. Again, the reviewers worked independently to ascertain which studies met the quality criteria, and consensus was reached through discussion. Attempts were made to obtain additional information from the study authors when needed.

Data extraction

Descriptive characteristics (such as quality of randomisation and blinding) and study results were extracted, recorded and entered into RevMan 5.1 (The Cochrane Collaboration, The Nordic Cochrane Centre, Copenhagen, Denmark). Additionally, letters and e-mails were sent to some authors of controlled trials asking for essential and additional information (statistics, sources of bias and details of randomisation). The summary statistics required for each trial and each outcome for continuous data were the mean change from baseline, the standard error (SE) of the mean change and the number of patients for each treatment group at each assessment. When changes from baseline were not reported, we extracted the mean, SD and number of patients for each treatment group at each time point, if available. We calculated the required summary statistics from the baseline and assessment time treatment group means and SDs, assuming in this case a zero correlation between the measurements at baseline and assessment time. This conservative approach was chosen, as it is preferable in a meta-analysis. For binary data, the numbers in each treatment group and the numbers experiencing the outcome of interest were sought. The baseline assessment was defined as the latest available assessment prior to randomisation, but no longer than 2 months prior. For each outcome measure, data were sought on every patient randomised. To allow an intention-to-treat analysis, the data were sought irrespective of compliance, or whether or not the patient was subsequently deemed ineligible or otherwise excluded from treatment or follow-up. Discussion between the two reviewers and the other authors was used to resolve any queries.

Data analyses

RevMan 5.1 was used for the meta-analysis. Analyses were adjusted to the random-effects model, owing to the heterogeneity of trials. Because trials used different tests to measure the same outcomes, the measure of the treatment difference for any outcome that we used was the weighted mean difference when the pooled trials used the same rating scale or test, and the standardised mean difference (SMD) (the absolute mean difference divided by the SD) when different rating scales or tests were used. For binary outcomes, such as clinical improvement or no clinical improvement, the odds ratio was used to measure treatment effect. A weighted estimate of the typical treatment effect across trials was calculated. Overall estimates of the treatment difference were employed, presenting the overall estimate from a fixed-effects model and performing a test for heterogeneity using a standard chi-squared statistic. The reviewers achieved consensus on the interpretation of the statistical analyses, seeking specialist statistical advice from the CDCIG as required. Non-randomised studies were described in tabular form and the reviewers discussed and reached consensus on the presentation of the findings in the background to the review.

Results

Studies included in the review

Ninety-four studies were identified since the last review through the literature search.47 Two reviewers independently assessed eligibility. Of the 94 references, nine studies met the inclusion criteria4855 and were included in the analysis. Three recent studies were left awaiting classification.5658 Our previous review47 included eight studies in the meta-analysis and six of these met the criteria for inclusion in this updated review.5964 Two studies from our previous review were excluded this time, as the data needed for the meta analysis were not available.65,66 Therefore, a total of 15 studies was included in the analysis (Figure 1).

FIGURE 1. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow chart of the review and selection process of studies.

FIGURE 1

The Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow chart of the review and selection process of studies.

Quality of included studies

The quality of each study was assessed according to the four criteria outlined in the Cochrane Collaboration Handbook:67 selection bias, performance bias, attrition bias and detection bias. The details of biases and descriptions of studies can be seen in Table 1. Performance bias was difficult to evaluate. With psychological interventions, unlike drug trials, it is impossible to totally blind patients and staff to treatment. Patients are often aware that they are being treated preferentially, staff involved may have different expectations of treatment groups and independent assessors may be given clues from patients during the assessments. There may also be ‘contamination’ between groups, in terms of groups not being held in separate rooms and staff bringing ideas from one group to another.

TABLE 1

TABLE 1

Description of included studies and bias

The latter effect would be reduced with clear therapeutic protocols, the existence of which was not mentioned in any of the studies, although during a face-to-face meeting with Professor Woods he stated that ‘Checks were made to ensure compliance with the therapeutic protocol’ (Bangor University, 2008, personal communication).

In relation to contamination, Wallis et al.63 and Baines et al.59 both stated that staff were unaware of the allocation of patients to groups, as they were removed from the setting for treatment, and several other studies described the groups being run in a separate or specific room.6,55,62,64 Most studies took steps to ensure that at least part of the assessment of outcomes was carried out by assessors blinded to treatment allocation. Only three studies48,60,62 did not report the blinding of assessors. Of course, even independent assessors may be given clues from participants during the assessments, but this was not reported as an issue in the studies reviewed here. Using independent assessors works well for evaluating change in cognition or self-reported mood, well-being and quality of life. Ratings of day-to-day behaviour and function are typically carried out by care staff, who may be more difficult to keep blind to group allocation, unless the group sessions are carried out in a separate location to which all participants are taken. Whether or not the patients were blind to treatment is a controversial issue, depending on how much information was given to them and their level of comprehension.

Several studies reported48,6264 that the reality orientation groups were held in separate areas, reducing the chance of contamination. Spector et al.6,55 said that the groups were run in a separate and specific room for the programme. The other studies did not provide information regarding where groups were held.49,51,53

All of the studies reported on attrition to the programme, although the intention-to-treat analysis plan was described in only two.6,51 Given the nature of the condition and the age of the participants, attrition in several studies was remarkably small, with zero attrition recorded in six studies4850,52,59,60 out of 180 participants. The largest attrition rate was reported in the study by Wallis et al.,63 in which there was 39% attrition in the group of participants with dementia. In this study, patients who attended < 20% of the group sessions were eliminated from the study. Requena et al.54 reported 32% attrition, but this was over a 2-year period. The two largest studies had rates of 19%59 and 17%6 over periods of 6 and 2 months, respectively.

Detailed treatment protocols were hard to find from the authors of the included studies, so the extent to which the cognitive stimulation was delivered as intended could be questioned. Some recent studies described that staff received training and/or supervision in running the groups. Chapman et al.51 described weekly meetings held to ensure that their treatment programme was implemented as designed:

Sub-groups were led by a licensed speech-language pathologist and three masters level speech-language pathology students; all underwent two hour training before the groups started; weekly meetings to ensure the programme was implemented as designed.

Onder et al.53 described how family caregivers were trained by a multidisciplinary team and given a manual and specific schedule for each session. No records were made, however, of how often caregivers delivered the sessions or how closely the manual was followed. The only available data from an early study came from Professor Woods, who stated during a face-to-face meeting that ‘A sample of sessions were tape-recorded and rated to ensure compliance with the therapeutic protocol’ (Bangor University, 2008, personal communication).

Meta-analysis

Data from the included studies were entered into ‘Metaview’ (the Cochrane term for meta-analysis). Data were identified, included and pooled from the 15 included RCTs,6,4855,5964 with a total of 718 participants (407 in experimental groups and 311 in control groups). Analyses were adjusted to the random-effects model, owing to the heterogeneity of trials, and SMDs, because trials used different measures to assess the same outcomes.

In order to evaluate the effect of cognitive stimulation on cognitive function, 14 RCTs that included useable data were included in the analysis (n = 658; 377 received treatment and 281 received no treatment or placebo). In comparison with the control groups at the post-treatment assessment, cognitive stimulation was associated with significant improvements on all measures of cognition. The overall results in the cognitive section were significantly in favour of treatment (Figure 2). The overall effect size (SMD) was 0.41 [95% confidence interval (CI) 0.25 to 0.57]. The results were strongly weighted by Breuil et al.61 (n = 61), Onder et al.53 (n = 137) and Spector et al.6 (n = 201), the largest studies. The largest effect sizes can be seen at the 12-month point in Requena’s et al.54 study [SMD 0.70 on the Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog)] and the Baldelli et al.60 study (SMD 0.99 on the MMSE), both of which offered above-average duration of exposure to cognitive stimulation. Other studies with longer exposure62 had below-average effect size and other studies which offer only 10 hours of exposure had above-average effect size (0.63), showing that these effects require replication, as the CIs are broad and cross zero.

FIGURE 2. Forest plot of comparison for CS vs.

FIGURE 2

Forest plot of comparison for CS vs. no CS: outcome – cognition. ADAS-Cog, Alzheimer’s Disease Co-Operative Study–Cognitive Subscale; CAPE I/O, Clifton Assessment Procedures for the Elderly – Information/Orientation scale; (more...)

To evaluate the effectiveness of cognitive stimulation on behaviour, three separate meta-analyses were conducted. One focused on outcome measures seen as a problem, the second focused on ADLs and the third focused on general behaviour outcomes. Three studies used behavioural outcome measures seen as a problem (Figure 3) including 166 participants, showing that no difference was apparent related to cognitive stimulation (SMD –0.14, 95% CI –0.44 to 0.17; z = 0.86; p = 0.39). The ADL measure results also did not achieve significance (Figure 4), including four studies, involving 260 participants. There was no benefit identified associated with cognitive stimulation (SMD 0.21, 95% CI –0.05 to 0.47; z = 1.56; p = 0.12). The third behaviour analysis (Figure 5) (general behaviour) showed a similar picture, with no difference emerging. Eight studies reported data on relevant scales, including 416 participants (SMD 0.13, 95% CI –0.07 to 0.32; z = 1.30; p = 0.20).

FIGURE 3. Forest plot of comparison for CS vs.

FIGURE 3

Forest plot of comparison for CS vs. no CS: outcome – ADAS-Cog. CS, cognitive stimulation; df, degrees of freedom; IV, inverse variance.

FIGURE 4. Forest plot of comparison for CS vs.

FIGURE 4

Forest plot of comparison for CS vs. no CS: outcome – MMSE. CS, cognitive stimulation; df, degrees of freedom; IV, inverse variance.

FIGURE 5. Forest plot of comparison for CS vs.

FIGURE 5

Forest plot of comparison for CS vs. no CS: outcome – other cognitive measure (information/orientation). CAPE-I/O, Clifton Assessment Procedures for the Elderly – Information/Orientation scale; CS, cognitive stimulation; df, degrees of (more...)

Five studies, involving 201 participants, used a self-report measure of mood (the Geriatric Depression Scale or the Montgomery–Åsberg Depression Rating Scale) (Figure 6). Cognitive stimulation is not associated with a clear improvement in mood (SMD 0.22, 95% CI –0.09 to 0.53; z = 1.42; p = 0.16). This is of similar magnitude to the finding of proxy report of mood and anxiety, where the SMD is close to zero (SMD 0.05, 95% CI –0.21 to 0.31) (Figure 7).

FIGURE 6. Forest plot of comparison for CS vs.

FIGURE 6

Forest plot of comparison for CS vs. no CS: post treatment, outcome – communication and social interaction. CS, cognitive stimulation; df, degrees of freedom; IV, inverse variance; MOSES, Multidimensional Observation Scale for Elderly Subjects. (more...)

FIGURE 7. Forest plot of comparison for CS vs.

FIGURE 7

Forest plot of comparison for CS vs. no CS: outcome – GDS. CS, cognitive stimulation; df, degrees of freedom; IV, inverse variance.

Four studies included self report well-being and quality-of-life measures (n = 219) (Figure 8). The analysis showed a significant improvement on this outcome measures following treatment, compared with control groups. The SMD was 0.38 (95% CI 0.11 to 0.65; z = 2.76; p = 0.006).

FIGURE 8. Forest plot of comparison for CS vs.

FIGURE 8

Forest plot of comparison for CS vs. no CS: outcome – quality of life. CS, cognitive stimulation; df, degrees of freedom; IV, inverse variance; QOL-AD, Quality of Life – Alzheimer’s Disease.

Follow-up

Owing to the great variety in follow-up data, the analyses were divided in two sections: short- and long-term follow-up. Short-term follow-up analysis included Baines et al.59 and Wallis et al.,63 who had a 1-month follow-up, and Baldelli et al.,60 who reported data from a 3-month follow-up. Long-term follow-up data included Chapman et al.,51 who reported useable data only from a 10-month follow-up, a much longer period in the context of the progression of dementia. For cognitive measures (Figure 9), the three studies with short-term follow-up reported data for 52 participants. The significant advantage for cognitive stimulation on cognitive measures seen immediately post treatment remained at this point (SMD 0.57, 95% CI 0.01 to 1.14; z = 2.00; p = 0.05). For the 54 participants included by Chapman et al.51 (Figure 10), there was no significant effect on either the MMSE (SMD 0.18) or the ADAS-Cog (SMD 0.12) at the 10-month follow-up. No other significant results were found in the other outcome measures at either the short- or the long-term follow-up analysis.

FIGURE 9. Forest plot of comparison for CS vs.

FIGURE 9

Forest plot of comparison for CS vs. no CS: post treatment, outcome – mood, staff-reported. CS, cognitive stimulation; df, degrees of freedom; IV, inverse variance; RAID, Rating of Anxiety in Dementia.

FIGURE 10. Forest plot of comparison for CS vs.

FIGURE 10

Forest plot of comparison for CS vs. no CS: outcome – ADLs. CS, cognitive stimulation; df, degrees of freedom; IV, inverse variance.

Discussion

The results of this updated meta-analysis of 15 studies with a total of 718 participants (407 receiving treatment and 311 controls) provide strong evidence of the benefits of cognitive stimulation for dementia on cognitive function. Moreover, they provide positive evidence that benefits can be extended to quality of life and self-reported well-being outcome measures. This review did not show a clear relationship between either the amount/frequency or the length of intervention and benefits to cognition, and the studies that showed most benefit were both shorter (Spector et al.6 and Breuil et al.61 having 7 and 5 weeks, respectively) and longer (Onder et al.,53 with 25 weeks). The MMSE was of a similar size to the SMD (1.30) of the Spector et al.6 and Onder et al.53 studies. Because MMSE scores decline, on average, by 2 to 4 points per year on the MMSE for dementia,68 the benefits of cognitive stimulation might equate to a 6-month delay in the usual cognitive deterioration.

Recent reviews of psychosocial interventions for dementia are in line with the findings of this review and give strong recommendation for the use of cognitive stimulation for dementia.8,69 Moreover, the 2011 World Alzheimer’s Report1 offered some evidence in relation to the benefits of AChEI medication and cognitive stimulation. This review also offered some evidence in relation to AChEI medication. Five out of the 15 included studies report data whereby all of the participants were prescribed AChEI medication in combination with cognitive stimulation. The additional effect of cognitive stimulation, over and above the medication (in four studies providing post-treatment data), was 3.18 points on the ADAS-Cog, compared with the overall finding (from seven RCTs) of 2.27 points. This supports the proposition that cognitive stimulation is effective irrespective of whether or not AChEIs are prescribed, and any effects are in addition to those associated with the medication.

Conclusions

Our review consolidates the growing evidence that cognitive stimulation improves cognitive function in people with dementia. It also indicates that cognitive stimulation benefits not only cognition but also self-reported well-being and quality of life, as has been reported by qualitative studies and people with dementia for a long time.70 These benefits are over and above any antidementia medication effects.

Work package 2: development of the maintenance cognitive stimulation therapy programme

This section reports the development of the MCST programme manual. We followed the MRC guidelines for the development and evaluation of complex interventions30 using a systematic review of the literature44 and the original CST trial programme6 to produce a full draft of a manual for a MCST programme. As in the main CST programme, maintenance sessions focus on ‘themes’, with a primary emphasis on cognitive stimulation, while incorporating the process of reminiscence therapy and multisensory stimulation. Group names and songs, a ‘reality orientation board’ and introductory exercises provided continuity between sessions.

Objectives

  • To identify, from the Cochrane review studies, the interventions that have shown to be effective and have had an impact at improving cognition and quality of life of people with dementia, including any negative effects.
  • To indicate the nature and quality of the interventions and identify key themes and elements.
  • To develop, from the analysed interventions and current CST training manual, 24 weekly sessions of MCST.
  • To develop a MCST training package for care staff based on the existing CST manual. This comprised a manual workbook, a DVD and training seminars.

Development of maintenance cognitive stimulation therapy sessions and workbook

We selected all relevant and effective interventions from the CST Cochrane review. We contacted study authors with the aim of obtaining additional information, hard copies of the intervention programme manuals and the manuals translated into English. The research team developed a database identifying key themes from the initial CST manual71 guiding principles and sessions, and included the 16 sessions developed for the MCST pilot project. A draft manual (version I) was produced based on the results.

The results from the analysis of the cognitive stimulation manuals, including the original papers, manuals and table database, were presented in a consensus workshop (comprising key academics, research staff and clinical staff involved in CST practice) and used to validate and review a subsequent draft of the MCST manual (version II), which included 24 maintenance sessions and was produced using the results of the consensus workshop. The MCST manual (version II) was discussed in focus groups with care staff (three groups), carers (three groups) and people with dementia (three groups) to review key themes, feasibility and potential modifications. The revised MCST manual was further modified in consultation with the attendees of the consensus workshop and key contributors to other aspects of process (e.g. a sample of care staff, carers, clinical staff and leading experts on CST).

The next draft of the MCST manual (version III) was produced to publication quality and was used in the development of a revised version of the CST training package compromising the revised manual, a CST/DVD including extra maintenance sessions, a PowerPoint® 2003 (Microsoft Corporation, Redmond, WA, USA) presentation, methods of evaluation and adherence. We developed the training package in consultation with trainers from Dementia UK.

Focus groups: a comparison of the views of people with dementia, staff and family carers

We included qualitative testing of the intervention through focus groups, developing a consultation process with people with dementia, family carers and staff. The aim was to identify improvements for the draft version of the MCST manual. Focus groups were the natural choice, as the aim was to gain comprehensive views of the key stakeholders with regard to the MCST programme. A key strength of focus groups is their ability to ‘tune in’ to the attitudes and perceptions of users regarding services.

Method

Sample

Focus groups were undertaken separately with three user groups that consisted of key stakeholders in the project. Three focus groups were carried out with people with dementia, three groups were carried out with staff and three groups were carried out with family carers of people with dementia. In total, 17 people with dementia, 13 staff and 18 family carers took part in separate focus groups. In the people with dementia groups, there were eight men (47%) and nine women (53%). Their mean age was 78 years, they all scored mild to moderate on the CDR scale46 and were able and willing to consent to participate in the focus groups. The staff groups consisted of three men (23%) and 10 women (77%), with a mean age of 36 years. All were permanent, paid staff, with at least 1 month’s employment, from residential homes, day centres or day hospitals. Their main duties involved caring for people with dementia. The family carers consisted of six men (33%) and 12 women (67%), with a mean age of 53 years. All were former or current carers of a person with dementia and had at least monthly contact during their time as a family carer.

Purposive sampling, for example sex, length of caring experience and dementia type, was used to ensure a wide range of participants. The centres selected were typical in size, organisational structure and management of others in the area. When people were recruited via local carers’ organisations (Uniting Carers for Dementia and Alzheimer’s Society), permission was also obtained from the management committees of these groups.

Procedure

We used the Noticeable Problems Checklist72 to screen potential participants who were then approached for their consent and further screening using the CDR scale. Participants with a CDR score of mild to moderate were included, provided that they did not meet the exclusion criteria (diagnosis of severe learning disability and/or diagnosis of depression, anxiety or other mental or physical illness adversely affecting their ability to participate in focus groups) and were willing to take part in the discussion groups. Seventeen participants met the inclusion criteria and agreed to take part. Members of staff who were working directly with people with dementia in the different centres approached were invited to take part in the groups. Eighteen family caregivers were recruited through Uniting Carers, Dementia UK and the Alzheimer’s Society. Participants were reminded that they could leave the group at any time.

Two researchers conducted self-contained, hourly focus groups. The sessions included a brief presentation about the overall project. One facilitator led the interview, with the second person actively listening and seeking clarification, to ensure the adequacy and accuracy of content as appropriate.73 The second facilitator also took substantive and methodological field notes during and immediately after the focus groups, as recommended by Burgess.74 A semistructured interview schedule based on the CST empirical literature was used as cues for open questions. The groups focused on the 24 themes developed for the MCST programme and the cognitive stimulation definition by Clare et al.11

Design

Focus groups were chosen in preference to individual interviews, as they are useful for stimulating discussion, generating ideas to explore topics in depth, gaining insight and obtaining rich data.75 A focus group interview schedule was constructed and developed to provide a framework for the discussions, which was piloted and adapted. The participants were encouraged to express their opinions and discuss issues through a series of open questions, which covered various aspects of mental stimulation activities, beginning with a presentation of the programme on a DVD and followed by open questions designed to elicit the activities and themes that participants particularly enjoyed and factors that contributed to the programme activities being stimulating and meaningful. Questions included ‘what do you think about use it or lose it/mental stimulation?’ and ‘could you tell us a bit about what sort of things you do that you find as being mental stimulating for you and you enjoy doing them?’. Pictures and materials used in the different themes and activities were used to help stimulate discussion in the participant groups. All groups used the same schedule, and participants were asked their opinions of what activities/themes they thought would be successful among people with dementia.

Analyses

The focus group interviews were tape-recorded and transcribed. The facilitators then reviewed the transcripts. The notes taken by the second facilitator were consulted to clarify the context of the discussion (e.g. benefits of being part of a group that was expressed by people with dementia focus groups). We used an inductive (data driven) thematic analysis approach76 to code and analyse the data. Inductive analysis allows themes to emerge from the data and is useful when the intent is exploratory and descriptive, as in our case. Consistent with various qualitative research methods, the focus group inquiry allows participants the freedom to provide information that does not necessarily fit with any expectation/hypotheses going into the research. This openness to new and unexpected information allows measurement designers to more fully ‘ground’ the content of new patient-reported outcomes in the concerns and issues that participants think are relevant.77

To develop a thematic codebook, researchers immersed themselves in the transcripts and rereading to gain deeper understanding of and familiarity with the content. One transcript was revisited and analysed into exclusive in vivo categories; that is, one theme was applied to one unit of meaning and the words used by the participant were adopted as the label of the theme. These themes were then applied to the remaining transcripts using a method of constant comparison to refine themes within the coding manual. During this process themes became more conceptual, with some original themes split into subthemes and others linked under one category depending on the emphasis placed on each theme within the transcripts. The resulting coding manual provided a meaningful way of understanding the views of the participants and assessing similarities and differences across the different groups (people with dementia, staff and family caregivers). Using the final codebook, all transcripts were coded independently by both researchers and then compared to reach 100% consensus.

Results

Thematic analysis revealed themes relating to perceptions and opinions of ‘mental stimulation/use it or lose it’, ‘examples of mental stimulating activities of daily life‘, ‘factors influencing successfulness and unsuccessfulness of a mental stimulation activity’ and ‘opinions and perceptions of specific themes of the presented maintenance CST programme’. Patterns of themes were found among the different groups (people with dementia, family caregivers and members of staff).

In the quotations below, PWD refers to the group ‘people with dementia’, FC refers to the group ‘family caregivers’, SC refers to the group ‘staff caregivers’, FG1 and FG2 refer to the focus group numbers and the digits refer to the line numbers in the transcript.

Mental stimulation: ‘use it or lose it’

This included discussing their opinions regarding mentally stimulating activities, ‘use it or lose it’, in terms of their views and beliefs about the effects of keeping the brain active. All participants showed general agreement about the usefulness of keeping the brain active.

People with dementia expressed the view that keeping the brain active was very important and a way of relieving frustration. They thought that it was essential for a healthy life and preserving their mental abilities, and that engaging in activities would keep the brain going. Some family carers expressed the view that the need for mental stimulation was universal and could bring neurological (building connections in the brain) and mental (helping with mood, anxiety, depression) benefits to everyone, and was important for promoting a healthy lifestyle and well-being. Staff and family carers also thought that there were added benefits to people with dementia in terms of increasing confidence, giving a sense of achievement, satisfaction, retaining skills and enjoyment.

No participants with dementia expressed negative views about the value of ‘use it or lose it’; however, there were concerns about the importance of keeping the brain active from members of staff and family carers groups who gave examples of individuals for whom the idea of ‘use it or lose it’ did not apply. Famous writers and politicians were given as examples of people who maintained a mentally stimulating, active lifestyle but nevertheless developed dementia. Some family caregivers expressed concerns that mental stimulation programmes may result in people with dementia losing confidence, experiencing anxiety or a sense of inferiority if confronted with their own cognitive deficits and difficulties as a result of undertaking a challenging mental activity.

Perceived stimulation in everyday life

Listening to music, singing and dancing, reading, painting, drawing, cooking and knitting were highlighted as being important for people with dementia. Factors that made an activity important included being interesting, being enjoyable, having a relaxing effect and helping to pass the time. Reading was a popular activity for most people with dementia as it raised their confidence and helped to increase interaction and participation when part of a group. In particular, talking and listening to others appeared enjoyable and were highly valued among people with dementia. They thought that talking to another person, to a pet or to the TV maintained their links with important current and past relationships and helped to reduce feelings of isolation.

Being part of a group helps considerably. I think being left on your own is not as effective as being part of a group. I belong to an African Caribbean group and I find that very stimulating. We talk on a number of things what we have done and why we did it. I think talking is very important.

PWD: FG1; 175–179

Family caregivers perceived that activities involving music (e.g. listening to music, singing, tapping and clapping) were those that people with dementia enjoyed the most.

Sounds and music are very important to stimulate something that’s there already so they recognise . . .

FC: FG2; 183–184

Those in the family caregivers group also spoke of having the opportunity to enjoy dinner together and to reminisce together by looking at photographs or sharing memories.

They learned a lot about others, everyone was telling their old past stories of how they went to school in shared shoes and things like this as a family. And we got so much information and it really stimulated them.

FC: FG2; 232–238

Staff caregivers thought that their planned activities were the most valuable stimulating activities for people with dementia. Staff participants identified reminiscence as an activity people with dementia enjoyed and often engaged in. However, there appeared to be little understanding of its value, and concern that it did not relate to the present.

I think we have to be careful with reminiscence, for me one of the best bits of this therapy is the variety of activities that you are going to do, otherwise it can get very repetitive as you tend to do things that you know work well, like reminiscence. You have to set goals within every session . . .

SC: FG1; 60–66

Factors influencing success of a cognitive stimulation programme

The perceptions of what made a CST programme successful were based on the person’s values and beliefs, with their interests and routines reinforcing a sense of identity and sense of belonging. Staff and family caregivers appreciated that the philosophy of the programme should be person centred and that enjoyment was a measure of what made programme activities successful.

People with dementia stated that basic human courtesies were important: being kind, trying to make others happy and not underestimating participants’ abilities.

Nothing that involves cruelty. As long as there’s kindness you can’t fault it.

PWD: FG1; 366

Being able to discuss, learn and make contributions was also mentioned.

I think it is very important to learn new things, you don’t stop learning ‘till you die.

PWD; FG1; 669–672

Other factors highly valued in the groups were activities that included reminiscence as an aid to orientation and activities that were provided in a multisensory way. Activities involving discussion and sharing opinions among the group were highly valued, as were challenging activities and quizzes requiring right or wrong answers.

Some people will remember more things than others you know. But it’s good for the brain . . .

PWD: FG1; 576–579

In contrast, family caregivers and staff participant groups stated that activities in the programme should not be based on right or wrong answers, so that people with dementia did not feel under pressure. ‘Playing it safe’ was perceived as being very important and this helped people feel more secure.

You have to adapt to the person and never ask them to do anything they can’t do because they have a sense of self and it will give them a sense of inferiority or inadequacy.

FC: FG2; 90–94

Most staff acknowledged that it was important to identify participants’ individual preferences, skills and abilities, as this affected their level of engagement in activities, whereas some recognised the need to adapt activities to a participant’s capabilities as a way of providing choice and contributing to their well-being. Some family carers stressed the importance of providing this programme to people only in the mild-to-moderate stages of dementia, as they thought that it would not be appropriate for people in more advanced stages.

The group participants should be of [a] similar level of dementia.

SC; FG2; 176

They also thought that group participants should be chosen based on having similar abilities and interests so that the group could run successfully and be stimulating and enjoyable. Both staff and family carer groups noted that attention needed to be paid to each participant’s level of hearing and vision, as they thought that high levels of impairment in either would limit a person’s participation.

You have to think about the personality dynamics within each group.

SC: FG2; 109

Staff and family caregivers also indicated that the group facilitator’s skills, knowledge, understanding of dementia and attitudes towards participants was also key to running the group effectively. The need for several facilitators was mentioned, as was limiting the number of group participants. Appropriate equipment was identified as another key factor to the success of this programme.

I think the size of the group has to be pretty small as an important factor.

FC: FG2; 388–391

Presented themes

A total of 19 themes was presented to the focus groups of people with dementia, family caregivers and staff. Fourteen themes were from the existing CST programme. Five new themes were developed from the literature review and the pilot MCST study (Table 2).

TABLE 2

TABLE 2

Maintenance themes

The five new themes

People with dementia rated useful tips, thinking cards and using objects as very positive themes. They stated that these themes were good for learning, hearing other people’s opinions and giving their own opinions in the group. They thought that the themes could help the group cohesiveness and would trigger conversation. Family caregivers and staff groups also thought that useful tips and using objects were good themes for the session and highly valued the involvement of reminiscence in the activities as an aid to orientation. Some staff expressed concern that the thinking cards theme would not work but others challenged that it would. Some family caregivers thought that the proposed activities for this theme would not be appropriate, as some people did not like ‘closing your eyes and imagining’ and might feel uncomfortable with this. Other carers liked this theme and thought that the questions were a good way of stimulating conversation and possibly helping group cohesion.

People with dementia rated visual clips discussion and art discussion as neutral. Although they liked the idea of group discussion, they did not feel enthusiastic about the topics presented. Staff and family caregivers groups rated these themes positively, as visual prompts were highly valued and they liked the idea of promoting discussion. Some staff had successfully run these types of activities previously with people with dementia and advised that materials be chosen appropriately.

Existing cognitive stimulation therapy themes

Participants were asked to rate and organise the presented themes as very positive, neutral or negative, and to rank them in order of those themes perceived as most and least successful. My life (childhood and occupations), food and orientation were perceived as positive themes; they were applicable to everyone, helped people to keep in touch with themselves and were multisensorial. Quizzes and word games were rated highly among people with dementia, who thought that they were very stimulating and helped the brain to keep working and ‘ticking together’. Family caregivers and staff also rated these two themes very highly. Physical games, sounds, faces and scenes, categorising objects, associated words and being creative were also rated positively by all groups, as these were good for stimulating recognition, reminiscence and discussion, offered multisensorial stimulation and promoted keeping healthy and active.

Number games was the only theme rated very low by people with dementia, who said that, as numbers were not something they related to very well and were a bit meaningless to them, this was not their preferred choice of activity. Family caregivers and staff shared similar views, as their previous experience indicated that number games required more one-to-one work with people with dementia, and were frustrating and pointless unless the numbers were related to pricing.

Using money and current affairs were rated very low by the family caregivers and staff groups but rated highly by people with dementia. Some family caregiver and staff participants stated that people with dementia did not often relate to current affairs (owing to the disease) and it would be meaningless to present topics about news unless reminiscence was used as a context for the information. However, people with dementia expressed a great interest in current affairs and stated that they loved reading newspapers. People with dementia also stated that they would enjoy talking about the value of money, and there were spontaneous comments about the value of money and the cost of bus journeys in the past and the present. In contrast, family caregivers and staff thought that money was too complicated and not a good theme, as it could be a very sensitive topic for some people with dementia.

Discussion

We used a novel approach to refine an existing psychological intervention programme that investigated the opinions, types of activities and qualities which make a cognitive stimulation programme more successful for people with dementia. An advantage of using focus groups with people with dementia is that sharing experiences may trigger recall. A possible disadvantage is that they rely on verbal communication and short-term memory, both of which are often impaired in people with the condition.78

Opinions about mental stimulation programme and key factors for success

People with dementia thought that keeping the brain active was essential and they acknowledged that this helped with their memory losses and difficulties. This finding supports Barnett’s79 statement that bereavement with memory losses is a major theme for people with dementia, who value the opportunity to be listened to. They also value being in a group. As indicated in other studies, socialising is an important activity for older people in care.8082 People with dementia valued quality social interactions, especially when being part of a group, and feeling a sense of belonging, reflecting Kitwood’s83 theory, which claims that positive interactions reinforce the personhood of those with dementia.

Conversely, staff and family carers expressed mixed opinions about the effectiveness of keeping the brain active; they cited examples of public figures who had developed dementia and said that the focus should be on the factors that would make a programme successful or unsuccessful for people with dementia. The main factors to consider when planning a CST group were grouped into participant characteristics (level of dementia, sensory impairments, personality, interests, life history), facilitator characteristics (knowledge about dementia, group skill and personality), group size and materials (multisensorial prompts, age appropriate).

Limitations

Staff focus groups included managers or senior carers, the presence of whom may have affected the opinions expressed by other staff members. Participants sometimes appeared reluctant to give personal examples, perhaps inhibited by the stigma of sharing information in a group, and this may be a disadvantage of using focus groups. We selected a thematic analysis, as it is a method for identifying, analysing and reporting patterns (themes) within data. Although thematic analysis is used widely, there is a lack of consensus regarding its precise methodology.84

Conclusion

Findings from the user focus groups regarding MCST programmes support the 2006 NICE guidelines on dementia85 that state that all people with mild to moderate dementia should be ‘given the opportunity to participate in a structured group cognitive stimulation programme’. Positive agreement was found among 14 themes and suggestions were made for the five remaining themes. These results were used to revise the manual for the MCST programme.

Work package 3: maintenance cognitive stimulation therapy for dementia – a single-blind, multicentre, randomised controlled trial of maintenance cognitive stimulation therapy versus cognitive stimulation therapy for dementia

Introduction

This section describes the study protocol for a pragmatic RCT of CST versus CST followed by a 24-week MCST programme undertaken with people experiencing mild to moderate dementia. This research programme aims to provide essential evidence to clarify the role of long-term CST interventions alone and in combination with cholinesterase inhibitors, and to assess the cost-effectiveness of this long-term vision.

Methods

Design

The design was a single-blind, multicentre RCT of CST groups for dementia versus MCST groups (Figure 11). After the completion of the initial CST programme (twice-weekly 45-minute sessions for 7 weeks), participants were randomly allocated to the treatment group (maintenance sessions weekly for 24 weeks) or the control group (usual care). Data were collected at baseline (baseline 0), after completion of the 7-week CST programme (baseline 1), and at 3- (follow-up 1) and 6-month follow-ups (follow-up 2). It was calculated that a sample size of 230 participants was needed at baseline 1 to detect an effect size of 0.39 on the ADAS-Cog,86 with power of 80% using a 5% significance level. Ethics approval was obtained through the Multicentre Research Ethics Committee (reference number 08/H0702/68). The clinical trial was registered as ISRCTN26286067.

FIGURE 11. Flow diagram of the trial: trial and randomisation stages.

FIGURE 11

Flow diagram of the trial: trial and randomisation stages.

Participants

The participants were people meeting the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV)87 criteria for dementia graded as mild to moderate on the CDR scale,46 with the ability to communicate, hear and see well enough to participate in the group, with no major physical illness or disability, and without a learning disability. Half of the sample was recruited from care homes and half was recruited from community settings, including CMHTs, day centres and voluntary organisations in London, Essex and Bedfordshire. Of the 21 centres initially contacted, one refused to participate and two were excluded owing to a lack of participants.

Randomisation

The randomisation process in this trial was undertaken in two stages: randomisation 1 and randomisation 2. Figure 11 sets out the two-stage randomisation process. The allocation ratio at randomisation 1 stage was 1 : 1; into either group A or group B, with both groups receiving 7 weeks of CST.

The allocation ratio at randomisation 2 stage was 1 : 1; into either the control group or the treatment group.

The sample was stratified to ensure that equal numbers of participants taking cholinesterase inhibitors were randomised into either the MCST or the control group. The North Wales Organisation for Randomised Trials in Health (NWORTH) was responsible for undertaking the remote randomisation. NWORTH is accredited as a Clinical Trials Unit by the UK Clinical Research Collaboration and funded as part of the Clinical Research Collaboration Cymru, notably for Health Technology Assessment trials.

Blinding

The participants could not be blinded to group allocation owing to the nature of the intervention. The researchers involved in collecting participant consent and in the interviews were not involved in the randomisation process and were blinded to treatment group allocation at follow-up. Our experience in the previous CST trial, as shared by those conducting similar projects, is that participants may occasionally and inadvertently inform researchers of the treatment they are receiving. We aimed to reduce this effect by giving explicit reminders to participants before the assessment visit and by the use of self-report measures whenever feasible. On completion of the two follow-up assessments, the assessors recorded their impression of which arm of the trial each participant belonged to and their confidence in that prediction. This enabled us to test whether or not the inadvertent loss of blinding leads to bias, and to adjust for any bias that was detected.

Intervention

Cognitive stimulation therapy is an intervention for people with mild to moderate dementia, designed following extensive evaluation of the available research, and is an evidence-based treatment.55 The programme consists of 14 45-minute sessions that are run twice-weekly. Each session incorporates the use of a ‘reality orientation board’, displaying both personal and orientation information, including the group name (as chosen by participants). The guiding principles of CST involve using new ideas, thoughts and associations; using orientation (but sensitively and implicitly); a focus on opinions rather than facts; using reminiscence as an aid to the here-and-now; providing triggers to aid recall; the creation of continuity and consistency between sessions; focus on implicit (rather than explicit) learning; stimulating language; stimulating executive functioning; and being person centred (treating people as unique individuals with their own personalities and preferences). The CST programme aims to create an environment in which people have fun, learn, strengthen their abilities and improve their relationships to other group members, thus maintaining their social and cognitive skills at their optimum ability.

The MCST programme is an evidence-based maintenance group therapy programme for people with dementia. It comprises 24 sessions of MCST, based on the theoretical concepts of reality orientation/cognitive stimulation and grounded in the original CST programme. The aim is to create an evidence-based maintenance group therapy programme for people with dementia, based on the same principles as those of the CST programme. A summary of the CST and MCST programme can be found in Table 3.

TABLE 3

TABLE 3

The CST and MCST themes development

Recruitment and training of facilitators

Each CST and MCST group had two facilitators, one from the research team and a cofacilitator who was a member of staff from the recruited centre (e.g. a care home). The facilitators had at least 1 year of experience in dementia care. The main facilitators often had a background in mental health nursing, occupational therapy or clinical psychology, as well as experience in dementia care and group facilitation skills. The use of two facilitators for each group enabled effective debriefing and reflection to occur at the end of each session. All facilitators attended 1-day CST training developed by one of the CST pioneers (AS) as part of the dissemination strategy. The training provided detailed background and description of CST, and used learning methods including group observation, role-playing and small group exercises.

Usual care

The participants allocated to the control group received treatment as usual (TAU). This can vary between and within centres, and may change over time but, in principle, the interventions offered to this group were also available to those in the active treatment groups. Therefore, the trial examined the additional effects of MCST. Our approach to costing the services and interventions received allowed us to monitor whether or not the TAU group had been receiving similar therapeutic interventions. The use of antidementia medication was recorded as part of the costing information collected. It was possible that participants in the TAU group were involved in some form of cognitive stimulation work during the 24 weeks of the study period. However, it is very unlikely that such a structured approach to CST was offered in any of the centres. It is this systematic group-based approach that was the focus of this evaluation.

Ethics arrangements

Risks and anticipated benefits for trial participants

There appears to be no documented harmful side effects of participating in CST groups, and no serious adverse reactions were apparent in the CST study. The participants in the groups consistently reported benefits, including enjoyment and feelings of validation and self-worth.88 Participants’ inclination to continue meeting following the sessions gave an indication of how valuable they found these benefits. All adverse events were recorded and reports as per the SHIELD adverse events policy.41

Consent

All recruited participants were in the mild-to-moderate stages of dementia, and were able to give informed consent for participation. Whenever possible, a family member or other supporter was included. It was made clear to participants and family caregivers that no disadvantage would occur if they chose not to participate. In seeking consent, we followed current guidance from the British Psychological Society40 on evaluation of capacity. If a participant’s level of impairment increased, so that they were no longer able to provide informed consent, the provisions of the Mental Capacity Act 200538,39 were followed.

Outcome measures

Primary and secondary measures were completed at baseline (time 0), after the 7 weeks of the CST programme (first follow-up, time 1), 3 months after beginning of the maintenance groups (second follow-up, time 2) and 6 months after the beginning of the maintenance groups (third follow-up and primary end point, time 3).

Primary outcome measures

  1. Cognition was measured using the ADAS-Cog.86 The ADAS-Cog consists of 11 tasks measuring the disturbances of memory, language, praxis, attention and other cognitive abilities, which are often referred to as the core symptoms of Alzheimer’s disease.
  2. Quality of life was measured using the Quality of Life – Alzheimer’s disease (QOL-AD) scale.89 The QOL-AD covers 13 domains of quality of life. It has good internal consistency, validity and reliability, and its use is recommended by the European consensus on outcome measures for psychosocial interventions in dementia.90

Secondary outcomes

  1. Cognition was measured using the MMSE,45 a brief, widely used test of cognitive function that has good reliability and validity.
  2. Communication was assessed using the Holden Communication Scale.91 This scale is completed by staff or family caregivers and covers a range of social behaviour and communication variables.
  3. Depression was assessed using the Cornell Scale for Depression in Dementia.92 This scale rates depression in five broad categories using information from interviews with staff and participants. Good reliability and validity have been demonstrated.
  4. Anxiety is assessed using the Rating Anxiety in Dementia scale.93 This rates anxiety in four main categories and uses information from interviews with staff and participants. It has good validity and reliability.
  5. Behaviour was assessed using the Neuropsychiatric Inventory (NPI).94 The NPI assesses 10 behavioural disturbances occurring in dementia patients. It has good validity and reliability.
  6. Activities of daily living were assessed using the Alzheimer’s Disease Co-operative Study – Activities of Daily Living Inventory (ADCS-ADL).95 The ADCS-ADL is a structured questionnaire originally created to assess functional capacity over the range of dementia severity. The sensitivity and reliability of the scale have been established.95
  7. Family caregiver health was assessed using the Short Form-12 Health Survey (SF-12).96 This scale measures generic health concepts relevant across age, disease and treatment groups. The SF-1296 comprises eight concepts commonly represented in health surveys. It is a self-administered measure that provides a comprehensive, psychometrically sound and efficient way to measure health from the patient’s point of view by scoring standardised responses to standard questions. This measure was used only when a family caregiver was available from the community sample participants.
  8. Costs were assessed using the validated Client Services Receipt Inventory (CSRI),97 adapted for this study. Used extensively in studies of mental health and dementia,13 the CSRI gathers comprehensive data on accommodation, medication and services received. In this trial the data covered the previous 3 months (at baseline and after treatment) or the 3 and 6 months’ follow-up points. Unit costs were then attached to services and support received, based on nationally relevant estimates of long-run marginal opportunity costs. Two quality-of-life measures were also included for cost–utility analyses. The EuroQol-5 Dimensions (EQ-5D)98 is a standardised instrument for use as a measure of health-related quality of life. It contains a three-level coding system for five dimensions. The instrument includes a global rating of current health using a visual analogue scale (VAS). The Dementia Quality of Life (DEMQOL)99 uses self-rated reports of quality of life administered by a trained interviewer; there is also a separate scale for family caregiver or members of staff reports, called the DEMQOL-Proxy. It covers five domains of quality of life. The DEMQOL has high internal consistency and acceptable inter-rater reliability, and indicates concurrent validity through moderate associations with the QOL-AD and DEMQOL.99

Analyses

The assessments were scored and data were entered into MACRO™ (version 3.0.84, Infermed, Elsevier, London, UK), Infermed’s electronic data capture system that produces a fully auditable trail for data from input to extraction for analysis. For cleaning and analysis purposes, SPSS (Statistical Product and Service Solutions; version 20, IBM Corporation, Armonk, NY, USA) syntax was written to extract the relevant data from MACRO. No changes were made to the SPSS files. The randomisation was stratified according to use of AChEIs and living situation (i.e. living in the community or in care homes). A paired t-test was applied to the data to establish if there was a difference between the pre and post scores on the various outcome measures. This analysis was then followed by a repeated measure linear model to allow various variables to be taken into account. The model was fitted using post score as the dependent variable, with living situation, marital status, sex and AChEI medication as factors and age as a covariate. Finally, a two-sample independent t-test was conducted to compare the Spector et al.6 control group results with the results seen in this group.

Complete-case data analysis was used initially to establish the results, followed by the analysis with imputations. When individual data points were missing within a scale, data were imputed by using scale/subscale means according to the validated rules for the measures. When an outcome measure total score was missing, it was imputed using a multiple imputation regression model comprising treatment group allocation, marital status, ethnicity, centre, age, sex, AChEIs, living situation (i.e. care home or community) and other outcome measures scores. The model used was a forward step model; that is, baseline outcome scores (baseline 0 and baseline 1) were used to help predict follow-up 1 scores, and then both of these were used to predict follow-up 2 scores. No data were imputed for those cases in which all assessments were missing. There were no participants missing for follow-up 1 who returned for follow-up 2.

Primary analyses used an intention-to-treat basis, analysing participants according to the group to which they were randomised and using all data. Multilevel modelling was used to address clustering within randomised groups. An analysis of covariance (ANCOVA) adjusted for baseline differences in outcome variables. Analyses considered the evaluation 6 months after the second randomisation as the primary end point. Secondary analyses considered the effects at 3 months. Age, sex, AChEI use and baseline scale scores were entered as covariates, and ‘centre’ was entered as a random factor. A secondary analysis included a trial platform for the MCST/AChEIs effectiveness that used the same model as for the complete analysis including an interaction term between AChEIs and the treatment group to identify any effect between the two factors for cognition (MMSE and ADAS-Cog) and quality of life (QOL-AD).

Results

Eighteen centres took part in the study trial (nine care homes and nine community), comprising 354 participants who were screened and 272 who participated in the CST groups. The reasons for exclusion included failure to meet the inclusion criteria (n = 42) or refusal to participate (n = 37). A total of 36 participants were lost between first and second randomisation (baseline 0 and baseline 1), leaving 236 participants randomised to the MCST or usual care group. The reasons for withdrawal can be found in the Consolidated Standards of Reporting Trials (CONSORT) diagram (Figure 12). Overall retention was good. At 6-month follow-up (follow-up 2) (primary end point), 199 participants (84%) remained in the study and there were 218 (92%) at 3-month follow-up (follow-up 1). The withdrawal rate was similar in both arms of the trial and the response rate, excluding deaths, was 89% at follow-up 2 and 96% at follow-up 1. During phase 1 trial CST mean attendance was 10 sessions and during phase 2 trial MCST mean attendance was 18 sessions.

FIGURE 12. The CONSORT diagram of participants through the trial.

FIGURE 12

The CONSORT diagram of participants through the trial. At phase 1, the mean CST attendance was 10 sessions and at phase 2 the mean MCST attendance was 18 sessions.

A total of 82 (31%) participants were receiving AChEIs, only 16 (14%) of whom resided in care homes. Table 4 compares community and care home participant characteristics in terms of age, sex and AChEIs, and provides information about the total participant group. Most of the sample had moderate dementia, with a mean MMSE score of 16.8 (SD 5.5) and a mean ADAS-Cog score of 34.3 (SD 12.9). The community group were less cognitively impaired at baseline (MMSE 18.9, SD 5.7) and had a higher mean ADAS-Cog of 30.5 (SD 13.1); this compared with a mean MMSE of 16.2 (SD 5.1) and ADAS-Cog of 40.6 (SD 11.4) for the care home sample. The total sample scored in the mid-range on the QOL-AD (mean 36.3, SD 12.9) and DEMQOL (mean 93.4, SD 11.4). Mean scores were in the mid-range on the measures of dependency (ADCS-ADL 42.3, SD 17.7) and behavioural symptoms (NPI 16.0, SD 12.9). The average attendance for the CST programme was 10.3 sessions (range 0–14 sessions) and 81% of participants attended seven or more sessions of the programme.

TABLE 4

TABLE 4

Baseline characteristics (before CST groups) according to living condition

Of the 236 participants randomised into the trial at second randomisation, 123 were allocated to the intervention MCST group and 113 were allocated to usual care. Table 5 shows that the groups appeared well matched in terms of demographic and clinical measures. The mean age was 83 years and most participants were white and female. A total of 135 participants (57.2%) were living in the community and 101 (42.8%) were living in care homes. One-third was taking AChEI medication (32%).

TABLE 5

TABLE 5

Baseline 2 characteristics (after attending CST groups) of 236 participants randomised to intervention and control

Predictors of change in cognition and quality of life between baseline and follow-up

A repeated measure linear model explored the impact of other variables. The model was fitted for age, living situation (community/care home), sex, marital status and taking AChEIs, and using post score as the dependent variable. As a result of fitting the models in this way, the results showed that both age and sex were important factors for the effectiveness of CST. For MMSE, age was a significant predictor of effectiveness of CST, with older participants appearing to benefit more. At the mean age of 82 years there was little difference between the pre and post score, but participants older than this appeared to benefit more, with a possible increase in MMSE score. For ADAS-Cog, age again was a significant predictor of the effectiveness of CST, with older participants benefiting more, in the same way as with the MMSE. Sex proved to be a significant variable in the complete-case study analysis, and showed a strong correlation with cognitive improvement, with female ADAS-Cog scores improving more than male scores.

Living situation was also shown to be an important variable for some of the staff-completed outcome measures (Table 6). For the NPI, a decrease in score was seen for the community sample [18.08 (SE 2.25) to 13.89 (SE 2.24)], while there was a small increase in NPI score for the care-home-based participants [11.35 (SE 2.48) to 13.42 (SE 2.48)]. This indicates a benefit for the community sample.

TABLE 6

TABLE 6

Differences before and after CST (people with dementia completed measures)

For the DEMQOL (proxy), both community- and care-home-based participants saw a mean increase. However, the care home increase [94.2 (SE 3.61) to 100.87 (SE 3.39)] was larger than the community increase [99.32 (SE 3.47) to 100.26 (SE 3.26)]. In fact, this can be viewed as the community sample remaining steady while the care home sample were brought into alignment with what was observed in the community.

For the imputed proxy EQ-5D utility values, age was seen as a significant factor, with older participants appearing to benefit more. For the proxy EQ-5D VAS, the community sample showed a mean increase from 60.19 (SE 3.63) to 67.52 (SE 3.36), while, conversely, the care home sample showed a small mean decrease from 65.47 (SE 3.29) to 62.72 (SE 3.04). In summary, we have identified benefits for the community sample on NPI scores and proxy EQ-5D VAS, and there is a benefit for care home sample for the DEMQOL-Proxy.

Change when comparing the results with those of a similar control group

Independent sample t-tests were used to compare the complete-case data set results with the Spector et al.6 control group, which had a mean age of 84.7 years and a 3 : 1 ratio of female to male. For the ADAS-Cog, the Spector et al.6 control group showed a mean reduction of 0.3, while the CST group showed a mean reduction of 2.72. This gives a mean difference of 2.42 [t = 2.27, degrees of freedom (df) = 240; p = 0.024], with CIs of 0.33 to 4.51. For the MMSE, the Spector et al.6 control group reduced by an average of 0.4 points, while the CST group saw a mean increase of 0.9 points. This gave a mean difference of 1.3 points (t = 2.76, df = 293; p = 0.006), with a CI of 0.38 to 2.22 points (Table 7). At follow-up, the CST group had demonstrated significantly better results than the Spector et al.6 control group on both MMSE and ADAS-Cog. There was no difference between the CST group and the Spector et al.6 control group on the QOL-AD.

TABLE 7. Meta-analysis comparison of mean change in CST groups vs.

TABLE 7

Meta-analysis comparison of mean change in CST groups vs. control group of the Spector et al. study

Using an adjusted ANCOVA comparing groups (treatment and controls), Table 8 shows the analysis of the primary end point (follow-up 2) and secondary end point (follow-up 1). At 6-month follow-up the treatment group had significantly higher scores on self-rated quality of life measured by the QOL-AD than the usual care group (p = 0.04).

TABLE 8

TABLE 8

Primary and secondary end-point results: adjusted analysis model

Cognition on the MMSE also favoured the MCST group but this was not significant. Centre emerged as a significant covariate in relation to the ADAS-Cog, Cornell and Rating Anxiety In Dementia scales. At 3 months’ follow-up, the MCST group had significantly higher scores than the usual care group on proxy-rated quality of life on both the QOL-AD (p = 0.008) and the DEMQOL (p = 0.04), as well as ADLs as measured by the ADCS-ADL (p = 0.05).

The MCST-AChEIs platform adjusted results at 6- and 3-month follow-up showed that the group receiving MCST plus AChEIs scored highest on the MMSE (see Table 3), than those receiving MCST only, those not receiving MCST and those not taking AChEIs. There is a significant interaction term between treatment group and taking AChEIs. Post hoc testing indicated that there was a significant difference between the MCST plus AChEIs group and the usual care and AChEIs group (p = 0.025). No significant interactions were found on any of the other outcome measures.

Numbers needed to treat

The number needed to treat is the calculation of the number of people who need to be treated in a particular intervention for one favourable outcome to be achieved. The number needed to treat calculation uses the proportion of participants who benefit in each treatment group. A number needed to treat analysis using QOL-AD change was used between baseline and follow-up 2, as this was the primary end point. An improvement of one SD on the QOL-AD (large effect size) was taken to indicate major clinical benefit, and 0.5 of a SD change (moderate effect size) was taken to indicate moderate clinical benefit. When calculating a large size effect (1 SD), the proportion benefiting was 0.18 (17/96) for the treatment group compared with 0.07 (6/81) for the control group and, therefore, 9.7 people needed to be treated for 1 to benefit (95% CI 5.0 to 129.9 people). When calculating a moderate size effect (0.5 SD), the proportion benefiting was 42 out of 96 (0.44) for the treatment group compared with 16 out of 81 (0.20) of the control group and, therefore, 4.2 people needed to be treated for 1 to benefit (95% CI 2.7 to 9.2 people).

Health economics

Methods

The main economic analysis compared MCST with usual care from a health and social care perspective. Secondary analyses also included the costs of unpaid carer time (societal perspective) and the cost of MCST as if it had been provided by health-care assistants rather than by the research team (‘in-practice’ implementation). A subgroup analysis also compared individuals receiving only MCST with individuals using an AChEI in addition. Health and social care services used by participants and inputs from unpaid carers were captured by the CSRI97 and completed with family carers or centre care workers. When possible, unit costs for the services were drawn from the Personal Social Services Research Unit compendium for 2011.100 We used a 3.5% discount rate (recommended by Her Majesty’s Treasury) for items providing benefit for more than 1 year, such as equipment or adaptations. Medication costs were obtained from the British National Formulary.101

The economic analysis estimated incremental costs and incremental effects and their CIs with seemingly unrelated regression methods with 1000 bootstrap replications. The information obtained through the economic analysis has led to the calculation of incremental cost-effectiveness ratios (ICERs) and to plotting cost-effectiveness acceptability curves (CEACs), showing the probability that MCST is a cost-effective addition to usual care against a series of hypothetical willingness-to-pay (WTP) values.

Results

Looking at the primary outcomes in the health and social care perspective (Table 9), the mean cost for each 1-point difference on QOL-AD was £266. Looking at the CEAC for this outcome, the probability that MCST would be seen as more cost-effective than usual care alone would be 90% at a WTP of about £1400 (Figure 13). There are no established WTP thresholds for QOL-AD against which to compare this finding, but a cost of only £1400 for a 1-point difference on a 40-point scale is modest. Based on previous studies,44 the effect size of ‘standard’ CST on the QOL-AD scale is around 0.4 SD, which represents a modest increment. In the current study the difference at follow-up for MCST was estimated to be 1.78 points (SD 0.34 points). A 2-point difference in QOL-AD can be considered to be clinically significant and a cost of £2800 to achieve such a result may be attractive to decision-makers. When the outcome was measured in terms of ADAS-Cog, the probability that MCST would be seen as cost-effective was low across all values of WTP (Figure 14).

TABLE 9

TABLE 9

Incremental cost-effectiveness ratios from health and social care perspective, over periods of 1–6 months and 1–3 months

FIGURE 13. Cost-effectiveness acceptability curve: MCST vs.

FIGURE 13

Cost-effectiveness acceptability curve: MCST vs. usual care – 6 months, health and social care perspective, with effectiveness measured on the QOL-AD scale.

FIGURE 14. Cost-effectiveness acceptability curve: MCST vs.

FIGURE 14

Cost-effectiveness acceptability curve: MCST vs. usual care – 6 months, health and social care perspective, with effectiveness measured on the ADAS-Cog.

Secondary economic analyses indicated that MCST was more cost-effective than usual care over the shorter period of 3 months when outcomes were measured in terms of proxy-rated quality of life (using QOL-AD and DEMQOL) and ADLs (using ADCS-ADL), but less cost-effective than usual care on all other outcomes, including quality-adjusted life-years (QALYs).

In sensitivity analyses we broadened the cost measure to include unpaid care and support, conducting the evaluation from a societal perspective. The cost-effectiveness case for adding MCST to usual care was, again, mixed. Subgroup analyses found that the combination of MCST and AChEI was more cost-effective than AChEI and usual care by reference to a number of outcomes, including cost per QALY.

Discussion

The benefits of CST on cognitive function are now well documented and the results of this study provide additional evidence for the effectiveness of the programme developed by Spector et al.6 The study showed that CST has a generalised cognitive benefit for people with dementia evident in comparisons of change scores, and in comparisons with the changes shown by the control group from the previous trial. Unlike the Spector et al.6 study and the recent Cochrane review,44 this study found a positive change in behaviour following the CST intervention as measured by the NPI. There was also a significant improvement in quality of life as measured by the DEMQOL and EQ-5D (VAS) (for both participant and proxy-rated versions), but no significant change was found using the QOL-AD. Previous studies have identified the need for quality-of-life measures in dementia that are able to detect any changes in quality of life in response to both interventions and the progression of the disease,102 so that they can be used to establish the benefits of treatment for people with dementia. In this analysis, the DEMQOL seemed to be a more sensitive instrument than the QOL-AD for measuring change in quality of life in dementia.103 Conversely, the two measures may be measuring different aspects of quality of life. These findings need to be explored further in future trials.

Predictors of success: who benefits most?

The benefits of CST were found to be independent of the use of AChEIs, which is in line with the Cochrane review findings and other studies.44,49,51,53 In line with the earlier study,6,104 greater improvements in cognition were associated with female sex. Men might be more reluctant to communicate as they are usually in the minority in most groups, with women outnumbering men in the groups by a ratio of 4 : 1.6,104 It may be that the sex majority dictates the style in which the groups are run, for example more ‘talking’ in female-dominated groups and more ‘doing’ in male-dominated groups. Further work is needed to explore these sex differences in response to CST and to develop interventions more geared towards the attributes of men.

The greater effect for the older people in this study is an unexpected finding. It may suggest that these older residents are experiencing more excess disability, showing impairment beyond that resulting directly from the dementia. It may be that they receive less stimulation in general than the slightly younger participants, and so benefit more from the new intervention. The findings of differences in outcomes between those living in the community and those living in care homes relate to all measures completed by a proxy: a family member or a member of staff. Their ratings may be affected systematically by different factors (e.g. family carer ratings are typically influenced by their level of strain; staff in care homes may change or have limited contact with residents on which to base their judgements). Further work is needed to explore these differences in perspectives and in the changes reported.

Maintenance cognitive stimulation therapy

This is the first major investigation to compare the short- and long-term impacts of CST for people with dementia. The investigation indicates that after standard CST (7 weeks, twice weekly), 24 weeks of MCST sessions both improves quality of life for people with dementia at 6-month follow-up and benefits quality of life and ADLs at 3-month follow-up, in comparison with the usual care control group. Cognitive stimulation programmes for dementia have a significant positive effect on cognition;44,105 however, there are concerns that the benefits may only persist for a limited period of time.44 These results indicate that a lower intensity input of once-weekly CST sessions can continue to be effective after the initial twice-weekly CST programme is completed. In comparison with the first baseline before CST, cognitive function in the MCST group had decreased by only 0.35 points on the MMSE, whereas cognitive function in the usual care (CST) group had decreased by 1.65 points at follow-up 2. The ADAS-Cog showed a similar pattern of results. On the basis that MMSE scores in mild-to-moderate dementia are expected to decrease by 2–4 points per year,106 these results suggest that, relative to no treatment, the MCST programme continues to have a protective effect on cognition. Other studies have also found that a longer-term cognitive stimulation intervention can be effective in reducing cognitive decline in dementia.107,108

However, benefits to cognition alone may not be sufficient to justify an extensive programme of intervention unless they are accompanied by other benefits, and a few studies have explored the long-term impact of psychosocial interventions on quality of life.109 This study indicates that the MCST programme improves quality of life and ADLs. As CST alone improves both cognition and quality of life,6,105 this provides a strong case for an ongoing programme of CST being supported in health and social care settings.

The MCST-AChEIs subanalysis results confirm the results of similar studies,6 suggesting that the additional effects of cognitive stimulation on cognition are over and above those of medication alone. In addition, the Cochrane review showed that type of control condition (e.g. usual care or social activities) made no difference to outcome, demonstrating that cognitive stimulation, rather than social activities, was responsible for the improvements in outcome.

Previous studies have shown that CST is effective in improving cognition and quality of life,6 and is cost-effective.13 CST is endorsed in NICE clinical guidelines.14

Findings from this new trial suggest that, although outcome gains were modest over 6 months, the continuation of CST appeared cost-effective in terms of self-rated quality of life, cognition measured on the MMSE and proxy-rated QALYs. MCST in combination with AChEIs offered cost-effectiveness gains when cognition was measured as the outcome.

The external validity of this pragmatic trial is high, as the sample came from a wide variety of settings. However, participants were almost exclusively white British and, therefore, solid conclusions on the applicability or effectiveness of this intervention to people of other ethnic or cultural groups cannot be made. Having said this, we recently successfully adapted and ran a local CST group in Hindi, and CST programmes have been run successfully in 20 countries.

Limitations of study

The SDs for the cognitive measures were higher than those in the original Spector study,6 suggesting that a larger sample may be needed to achieve significance differences in cognition after MCST relative to CST alone. Proxy measures (e.g. the ADCS-ADL and NPI) were rated by the family carer or staff members who were aware of participant group allocation, and so this might have introduced detection bias into the ratings. The subgroup of people on AChEIs might also have received extra psychiatric services during the trial. However, comparisons of the AChEIs-only group and MCST plus AChEIs group data confirm that the effects of the MCST programme are above and beyond those of medication alone.

Conclusion

This project provides further evidence that CST benefits cognition and quality of life for people with dementia, and suggests that the benefits are in addition to the effects of antidementia medication. CST appears to be more beneficial for women and people older than the average age of those in the study. This provides good evidence for the clinical effectiveness and cost-effectiveness of continuing CST beyond the initial programme and shows that quality of life and ADLs continue to benefit from extended CST.

Work package 4: maintenance cognitive stimulation therapy in practice

Cognitive stimulation therapy has been shown to improve cognition and quality of life, but little is known about the best way of ensuring implementation of CST in care settings. A recent pilot study found that one-third of people who attended CST training went on to run CST in practice, but staff identified a lack of support as a key reason for the lack of implementation.110

The research project was divided into three studies. The Staff Training and Outreach (STANDOUT) and Monitoring and Outreach (MONOU) studies assessed the effects of outreach support on uptake of CST in practice, as well as looking at staff outcome measures and adherence to the programme. The observational study recruited people with dementia to complete minimal outcome measures before and after CST, and after the delivery of the MCST programme.

Methods

Design

The STANDOUT and MONOU studies differed in how staff members were recruited into the research and in their previous exposure to CST. Staff members in the STANDOUT study were new to CST, having had no prior experience of the programme, whereas staff recruited into the MONOU study had either previously attended CST training or purchased the CST ‘Making a difference’ manual. The observational study looked at the effects of CST and MCST on people with dementia in the practice context delivered by staff members. The three studies together provided evidence on both the most effective way of facilitating the implementation of CST, and uptake and effectiveness of the approach in a clinical context (Table 10). Ethics approval was obtained for the project through the Multi-centre Research Ethics Committee (reference number RP-PG-0606-1083). The clinical trial was registered as ISRCTN28793457.

TABLE 10

TABLE 10

Project overview

STANDOUT trial

The design was a pragmatic, multicentre, single-blind, two-treatment-arm RCT. The STANDOUT trial sample comprised dementia care staff from specialist and non-specialist dementia care settings. All participants received the training package as TAU, consisting of a CST training day, a training DVD, the CST ‘Making a difference’ manual and the MCST ‘Making a difference 2′ manual, and cluster randomised by centre prior to the training day into the intervention group or to TAU. The intervention group consisted of a local co-ordinator, e-mail support and an online forum. Each staff member was expected to complete three questionnaires, the first before the training day and the others at 6 and 12 months thereafter (Figure 15).

FIGURE 15. Flow diagram of the STANDOUT trial and assessment schedule.

FIGURE 15

Flow diagram of the STANDOUT trial and assessment schedule.

Recruitment

Those recruited to the trial included staff from care homes, day centres and NHS trusts from various locations across the UK. The trial was advertised through the Journal of Dementia Care, the National Care Forum and the UK Clinical Research Network study portfolio, and referrals were made through the commercial CST training day. The researcher also followed up individuals who, prior to the start of the research, had expressed an interest in CST or in attending a CST training day. Using the inclusion criteria, the researcher was then able to assess all expressions of interest from individuals, centres and trusts.

Participants

Staff members were screened to ensure that they met the inclusion criteria: (1) having adequate written and spoken English; (2) being able to complete online assessments at three time points; (3) having at least two other team members to run groups with; (4) reaching agreement with management to have 2 hours per week set aside to run the CST groups, and 1 hour following on from this for the 24-week MCST programme; and (5) being able to provide between five and eight people with mild-to-moderate dementia who were willing to participate and met the inclusion criteria (described in the observational study). Attempts were made to recruit a minimum of three staff members per centre for the logistical reason of being able to consistently run the groups. Originally, 40 centres were considered feasible to recruit the 120 staff members required for the STANDOUT trial; however, in total 173 staff members across 50 centres were recruited into the study. This was because there was a higher demand for receiving the CST training than for entering the MONOU study and, as the analyses for the STANDOUT and MONOU studies were combined, statisticians on the SHIELD programme advised that this would not compromise the integrity of the trial, as there had always been the intention to analyse the results from both the STANDOUT and MONOU trials together. Working on the premise of a 15% attritition rate, the sample size provided sufficient numbers for (1) the staff training outreach support versus no outreach support, and (2) monitoring and outreach versus no outreach support to estimate effect size and the feasibility of the trial. The attrition rate was an estimation based on previous research conducted in CST.111

Training package

The CST ‘Making a difference’ and MCST ‘Making a difference 2′ manuals, along with the staff training DVD, were distributed to all staff members participating in the study. The staff training DVD comprises an introduction by Dr Aimee Spector, a table listing the order of the CST and MCST sessions, and key principles. There is also video footage of each CST and MCST session run with people with dementia for staff to observe and questions after each clip to encourage reflective learning and discussion. All staff members attended a CST training day. The training comprised different perspectives of dementia, main psychosocial approaches for dementia, development and evaluation of CST, session themes and examples of activities for sessions, key principles, planning of sessions and the setting up of a group and reflective learning of issues that arise when implementing and running groups. The training used learning methods, such as role-play, and small group exercises and the DVD was used when time was spent reflecting on the sessions and critically appraising how the session had been run. At the end of the training day, time was taken to emphasise the importance of completing the attendance and adherence forms after each completed session; these forms would then be collected by the researcher at the end of the research time.

Randomisation

Cluster randomisation occurred prior to staff attending the CST training day to ensure that staff members from the same centre received the same level of support. The allocation ratio for randomisation was 1 : 1, into either the intervention or TAU. NWORTH was responsible for undertaking the remote randomisation.

Treatment as usual

Staff members within centres randomised to the control group attempted to deliver the CST as usual without the additional outreach support. The training package offered to the intervention group was also available to those in the control group. Therefore, the trial examined the additional effects of the outreach support.

Intervention

A pilot study conducted, prior to this research being undertaken, identified that outreach support should consist of (1) an online forum, (2) e-mail support and (3) local supervision.110 The online forum was an online discussion site. It was accessible using a username and password. The first time a person attempted to enter the site, an e-mail was sent to the researcher for their approval to ensure that the person in question had been randomised to the intervention group. The use of login details allowed a record to be kept of the number of people accessing the service and how many times they did so. Staff members were able to write up a variety of messages, such as comments on sessions, asking questions and asking for advice. The same researcher who had extensive experience of CST and experience of running groups delivered the e-mail support and local supervision, unless the centre was able to provide their own person to deliver the supervision. Both services were made available as often as was needed. The role of the local supervisor was to help to resolve practical issues that were encountered in attempting to run CST groups. The supervisors recorded all the support given.

Primary outcome measure

The primary outcome measure was the total number of sessions attended over the duration of the CST and MCST programme. This was determined by the total number of sessions run multiplied by the average number of people at each. This was recorded by staff using the monitoring progress form located in the ‘Making a difference’ manual112 that included recording who was in attendance, and rating level of interest, communication, enjoyment and mood on a scale of 1–5 (i.e. 1 = no interest, 2 = little interest shown, 3 = some interest shown, 4 = interest shown and 5 = great interest shown). This measure was completed at the end of each session from the start of the CST programme to the end of intervention delivery, until the MCST groups had been completed or the groups had been discontinued.

Secondary outcome measures
  1. Adherence to the CST and MCST programme was measured using an adherence list designed for the trial and was based on 18 key principles developed as part of the MCST programme.112 The adherence records were reviewed by a member of administration to mark whether or not staff adhered to the key principles as laid out in the ‘Making a difference 2′ manual and to highlight any similar issues that were arising across centres. Any ambuiguity in participants’ responses was discussed with a researcher until consensus was reached regarding whether or not the participant was adhering to the key principles. Job satisfaction was measured using the Minnesota Satisfaction Questionnaire.113 This consists of 100 questions and comprises 20 dimensions with five items per scale, using a 5-point Likert rating scale. The measure has adequate internal reliability.
  2. Staff members’ approach to dementia was measured using the Approaches to Dementia Questionnaire (ADQ).114 The ADQ has 19 statements about the person with dementia and the care that they receive. The scale has high validity and good reliability using Cronbach’s α for its person-centeredness and hopefulness subscales.
  3. Knowledge was measured using the Dementia Knowledge – 20 scale.115 This consists of 20 questions for which there are five possible answers. The scale has sufficient reliability and was administered at baseline and final follow-up only.
  4. Perceived sense of competence was measured using the Sense of Competence in Dementia care – Staff questionnaire.116 It comprises 17 items categorised into four subscales: professionalism, building relationships, care challenges and sustaining personhood. The scale has good internal consistency.
  5. Learning characteristics of staff were measured using the brief version of the Learning Transfer System Inventory (LTSI).117 The constructs of the LTSI are validated using common factor analysis.118 The brief form comprises 16 questions that are categorised into four major groups: trainee characteristics, motivation, work environment and ability. All of the items use 5-point Likert-type scales from 1 (strongly disagree) to 5 (strongly agree).110
  6. Barriers to change in the workplace were measured using the Barriers to Change Questionnaire.119 It comprises 19 questions focusing on institutional constraints, support from colleagues, philosophical opposition, client dissatisfaction, interference and positive factors, and allows the addition of any further comments.
  7. The emotional and behavioural responses relating to challenging behaviour presented by the person with dementia were measured by the Controllability Beliefs Scale.120 The scale has 15 items based on a 5-point scale. Higher scores indicate higher staff member belief in the level of control demonstrated by the person with dementia. The scale has good internal reliability.
Consent

Ethics and local R&D approvals were obtained and all staff members provided informed consent to participate in the trial. Consent was also sought from a manager in each centre recruited.

Blinding

Although staff members could not be blinded to their allocation, the majority of the assessment data was completed online and independently of the research team. To maintain anonymity throughout the trial, an administrator on the SHIELD programme team assigned an identification number to all participants who completed the survey. The researcher administering the outreach support had the contact details of the staff members but was unaware of their individual code, and hence they were blinded to identifying the staff members. The staff members were aware of their code and it was emphasised that it was not to be discussed with the research team member. A reminder was also included in the e-mail that the administrator sent to the participants asking them to complete the follow-up assessments.

MONOU trial

The design was a pragmatic, multicentre, single-blind Phase IV trial. The participants were staff members from centres that had previously purchased the CST ‘Making a difference’ manual or had attended a CST training course. Once enrolled in the research, all staff received the free MCST ‘Making a difference 2′ manual and DVD. It was recorded whether participants had the manual only or manual and training before centres were cluster randomised into outreach support or TAU (Figure 16). The time points for completing the questionnaire were the same as for the STANDOUT trial. However, the participants also completed a retrospective questionnaire on their use of CST in practice prior to the research.

FIGURE 16. Flow diagram of the MONOU trial and assessment schedule.

FIGURE 16

Flow diagram of the MONOU trial and assessment schedule.

Recruitment

Recruitment of staff members for the MONOU study was created from records of purchased CST manuals via Hawker publications and a database of attendees generated from previously run CST training days. Staff members were then contacted to determine if they were interested in participating in the study. A CST poster also advertised the research on the CST website (www.cstdementia.com), on the SHIELD website (www.ucl.ac.uk/shield) and through the Journal of Dementia Care. In addition to this, as the project was a UK Clinical Research Network portfolio-adopted study, NHS trusts nationwide could approach the research team for their eligibility to participate in the research to be assessed.

Participants

The participants were dementia care staff who had the CST manual or had attended the CST training day and were able to implement the CST programme once or twice weekly followed by the MCST programme. The screening and inclusion criteria matched those for the STANDOUT study, except a minimum of one staff member could be recruited per centre; because of this it was estimated that between 40 and 120 centres were required to recruit 120 staff members. This figure also accounts for a 15% (240 × 0.75 = 180) attrition rate. However, in total 68 staff members were recruited across 13 centres. This was due to difficulty in identifying and recruiting suitable participants.

Randomisation

Once staff had completed their baseline assessment, it was recorded who had the manual or training, and randomisation occurred. This was created by dividing into two clusters, taking into consideration centre size and type of previous training (manual vs. manual and training); staff were then independently randomised to receive the intervention or TAU by remote e-mail service to NWORTH. Owing to differing numbers in each centre, an effort was made to keep similar numbers in the control and experimental groups, with an allocation ratio for randomisation of 1 : 1, into either the intervention or the TAU group.

Treatment as usual

Sites randomised to the control group were expected to deliver the CST as usual. Each centre randomised into TAU received a monthly telephone call from a member of administration to see what stage they were at in the delivery of the programme, but they were not given any advice. The trial examined the additional effects of the outreach support and long-term effect in practice.

Intervention

The outreach support options were identical to those in the STANDOUT study, with one difference: to emulate CST in practice, staff members identified the local supervisor, and, if this was not possible, it was recorded and the staff members were then offered the researcher’s services. All of the staff members randomised to receive outreach support were encouraged to use all options available to them, but this was not compulsory. Staff members were monitored to measure their usage of the outreach support options. A monthly telephone call was also made by the researcher to each centre in receipt of outreach to determine what stage of the programme they were at and, if advice was sought, this was recorded accordingly.

Primary outcome measure

Attendance as the primary outcome was identical to that in the STANDOUT trial. If the response to a person attending the session was left blank and no reason was given for this, the researcher assumed that the person had not attended the session. If a person was introduced part way through the programme, the sessions that had not been offered to them were excluded from the total number of sessions considered, as the person’s non-attendance at these sessions had not been because of a refusal to attend but because the sessions had been unavailable by the time they joined.

Secondary outcome measures

The secondary outcome measures were identical to those in the STANDOUT trial.

Consent

Informed consent was gained from each staff member and a member of management, and this was identical to the STANDOUT trial. Ethics and local R&D approvals were obtained.

Blinding

The procedure for blinding was identical to that in the STANDOUT trial.

Analyses
Demographics

In total, 300 individuals, 28 centres and 12 trusts expressed interest or were approached to participate in the research. Overall, 241 staff members were recruited across 63 centres in both the STANDOUT and MONOU trials. All of the staff members consented and completed the baseline assessment before randomisation. Four people were randomised by association, after randomisation had occurred but before the centre was aware of whether or not they were in receipt of the intervention. In total there were 115 (48%) people not in receipt of the intervention across 28 centres and 126 (52%) who were in receipt of intervention across 35 centres. The majority of staff members were female (88%) and white (71%). Generally, staff had between 1 and 10 years of experience (43%), with 41% having a qualification up to diploma/degree level. Most sites were dementia specialist settings (64%), with 33% being care home settings (Table 11).

TABLE 11

TABLE 11

Staff demographics

Attendance in STANDOUT and MONOU trials

A combined analysis of the results from the STANDOUT trial (175 participants) and the MONOU trial (66 participants) was carried out. The primary outcome was the total number of sessions attended for each centre (total number of sessions run × average number of people at each) per centre, assuming an intracluster correlation of p < 0.05.

For the group receiving the intervention of outreach support, 18 (51%) out of 35 centres went on to deliver the CST programme, whereas in the TAU group 12 (43%) out of 28 centres delivered the programme (Table 12).

TABLE 12

TABLE 12

Number of CST programmes delivered based on intervention

A chi-squared statistic suggests that there is not a statistically significant difference in the proportion of CST groups run in the intervention group and the number of CST groups run in the TAU group (p = 0.458).

Leading on from the CST programme, 12 (67%) out of the 18 centres in the intervention group went on to deliver the MCST and 8 (67%) out of 12 centres in the TAU group delivered the MCST programme (Table 13).

TABLE 13

TABLE 13

Number of MCST programmes delivered based on the intervention

A chi-squared statistic suggests there is a statistically significant difference, with more MCST groups run in the intervention group than in the TAU group (p = 0.011).

Attendance

Staff at each centre running the CST and MCST programmes marked the attendance of the people with dementia after each session was completed. This information was then collected at the end of the programme and the researcher entered it into a Microsoft Excel® 2003 spreadsheet (Microsoft Corporation, Redmond, WA, USA). By calculating the primary outcome of total number of sessions attended for each centre, the researcher was able to group the centres by the average number of people attending during the programme. Centres unable to run the programme scored zero, centres considered to have delivered CST poorly scored < 41 overall (and so had, on average, fewer than three group members) and centres considered to have delivered CST OK scored between 42 and 69, reflecting that, on average, there were three or four group members. Finally, CST was considered good if a centre scored ≥ 70, demonstrating that, on average, in these centres there were ≥ 5 group members over the duration of the programme (Table 14).

TABLE 14

TABLE 14

Whether or not in receipt of intervention and rating of CST delivery

A chi-squared statistic suggests that there is no statistical significance between the centres that were in receipt of the intervention and those that were not, and the delivery of the programme as determined by the number of average attendees across the CST programme (p = 0.87; 2 df). However, Table 14 does not reflect one centre that ran the programme in the intervention group, as the attendance and adherence booklet was mislaid, so for the purposes of this table the centre has been included in the intervention ‘no groups’ column.

From the centres that followed the CST programme with the MCST programme, the primary outcome of total number of sessions attended enabled the researcher to group the centres according to the average number of people who attended across the delivery of the programme (24 sessions). A score of 0 was assigned to centres in which groups were not run; centres in which MCST was considered to have been delivered poorly (a score of < 71 indicating fewer than three group members) were assigned a score of 1. Centres with between 3 and fewer than 5 people, on average scoring between 72 and 119, were given a score of 2 and those centres with ≥ 5 group members, as demonstrated by a score of > 120, were assigned a score of 3 (Table 15).

TABLE 15

TABLE 15

Whether or not in receipt of intervention and rating of MCST delivery

A chi-squared statistic suggests that there is no statistically significant difference between the centres in receipt of the intervention and the average number of attendees in the delivery of the MCST programme (p = 0.35; 3 df).

A comparison was also carried out to look at the different pathways by which participants entered the trial, either ‘new’ to CST (STANDOUT) or with previous experience (MONOU). Of the centres recruited into the STANDOUT trial, 17 out of 50 went on to deliver the CST programme. The MONOU trial had a total of 13 centres and, of these, 12 went on to deliver the CST programme (Table 16).

TABLE 16

TABLE 16

Strand of trial and success of CST

A chi-squared statistic suggests that there is a statistically significant difference, in that more CST groups were run in the MONOU group than in the STANDOUT group (p = 0.001; 1 df).

This comparison was also considered for the centres within the two strands of the trial that went on to deliver the MCST programme. Within the STANDOUT trial, 9 of the 17 centres continued with the MCST programme, whereas in the MONOU trial 11 of the 13 centres went on to deliver the MCST programme (Table 17).

TABLE 17

TABLE 17

Strand of trial and success of MCST

A chi-squared statistic suggests there is a statistically significant difference, in that more MCST groups were run in the centres recruited into the MONOU trial than in those recruited into the STANDOUT trial (p = 0.000; 3 df).

Access of outreach support

The researcher recorded outreach support each time it was accessed by a staff member in the intervention group. In total, three centres signed up to the online forum, the e-mail support was accessed twice and local supervision in the form of a telephone call was used 15 times. However, within this staff members initiated three of the telephone calls, whereas the remaining 12 were the monthly follow-up support telephone calls in which staff members were asked if they needed support. It was also noted that within the MONOU trial two of the trusts (Kent and North Staffordshire) had a support network already set up that they accessed in monthly meetings across the duration of their involvement in the research.

Secondary outcome measures
Adherence

To determine if the centres running the CST programme were adhering to the key principles, one-third of the CST adherence records were randomly chosen. The adherence questions were devised with the CST key principles in mind (Table 18). There were five CST records chosen from the centres in receipt of the intervention and five records from centres in the TAU group; these comprised six centres in the STANDOUT trial and four centres in the MONOU trial.

TABLE 18

TABLE 18

Adherence and related key principles

When the responses were recorded, any adherence questions left blank were considered incorrect and for any adherence sheets missing these were deducted from the overall score that the centre obtained. The self-reported adherence score of not adhering to the key principle across the delivery of the CST programme ranged from 11% to 24%. The three main key principles that were not adhered to were: (14) were group members given the choice of activities for the session, (9) did anyone struggle to join in with the session and (7) were indirect questions used during the session. However, when key principle 17 was reviewed by the researcher there was either no comment or it was stated that they were following the session structure. So, it was considered that the question was ambiguous and needs further clarification in the future. With regard to key principle 9, when the centre highlighted that people were struggling within the centre it generally was a result of one or two group members being more impaired than the others or being unwell on the day of the session. It was expected that people’s participation over the time frame of the programme might vary and it is arguably a positive sign that the staff were able reflect on the session and identify participants struggling during the session, as one would hope that this would enable the staff to then cater to the individual needs of each participant and to keep the group as inclusive as possible. Key principle 7 identified that there was a lack of indirect questions used when delivering the programme. The use of indirect questions is important to ensure that people do not feel put on the spot, so it is useful to understand that this is a principle that staff find difficult to adhere to.

Staff outcome measures

An ANCOVA was applied to the secondary outcomes measures including job satisfaction, approaches to dementia, dementia knowledge, responses relating to challenging behaviour, perceived sense of competence and learning characteristics, as well as barriers to change. Each measure was calculated factoring in sex, age, frequency in the delivery of CST, type of centre, whether or not it was a specialist dementia setting, how the participant was recruited into the project (MONOU/STANDOUT) and, finally, if they were in receipt of the intervention.

A one-way between-group ANCOVA was conducted to compare the effectiveness of outreach support as the intervention versus TAU on participants’ job satisfaction, approaches to dementia, dementia knowledge, responses relating to challenging behaviour, perceived sense of competence and learning characteristics, as well as barriers to change. The independent variable was the type of intervention (outreach support or no outreach support) and the dependent variables consisted of scores on the secondary outcomes at 6 and 12 months. Participants’ scores at baseline in these measures were used as the covariate in the analysis. Preliminary checks were carried out to ensure that there was no violation of the assumptions of normality, linearity, homogeneity of variances, homogeneity of regression slopes and reliable measurement of the covariates.

Job satisfaction as measured by the Minnesota Satisfaction Questionnaire113 evaluated job satisfaction using a score ranging from 100 to 500, with a higher score indicating a higher sense of satisfaction. In general, job satisfaction increased for both the control and intervention groups at follow-up 1, but decreased at follow-up 2 to lower than the baseline score. After adjusting for baseline scores, job satisfaction showed no statistical difference at follow-up 1 (p = 0.72) or follow-up 2 (p = 0.99).

Approach to dementia was measured using the ADQ114 and looked at the attitude of the staff members, with a low score suggesting a negative attitude and a higher score indicating a positive attitude (19–95). The score in both the control and intervention groups increased slightly over the duration of the research. However, there was no significant difference for approaches to dementia on the hope subscale at follow-up 1 (p = 0.82) or follow-up 2 (p = 0.97), or person-centred subscale at follow-up 1 (p = 0.18) or follow-up 2 (p = 0.95).

Perceived barriers to change, including institutional constraints, support from colleagues, philosophical opposition, interference and additional factors, were measured using the Barriers to Change Questionnaire,119 with a higher score indicating more perceived barriers (0–80). Overall, the score decreased at follow-up 1, but then increased at follow-up 2. For barriers to change there was no significant difference at either time point, follow-up 1 (p = 0.54) or follow-up 2 (p = 0.96).

To look at training transfer, the brief LTSI117 was used looking at learning characteristics, motivation, work environment and ability/enabling, with a higher score (16–80) indicating a more positive transfer of learning. The scores improved at follow-up 1 compared with baseline and, although they decreased at follow-up 2, still remained higher than the baseline score. For transfer of learning there was no significant difference at follow-up 1 (p = 0.1) or follow-up 2 (p = 0.34) when comparing the intervention and control groups.

To determine the level of control that the staff member considered the person with dementia to have over their own behaviour, the Controllability Beliefs Scale120 was used, with a higher score indicating a higher level of control (15–75). The challenging behaviour scale was split into two subscales: high control and low control. Over the duration of the study, both the intervention and the control groups attributed a lower controllability rating, although neither follow-up 1 (p = 0.56) nor follow-up 2 (p = 0.84) showed a significant difference. In addition, although the lower controllability score increased at follow-up 1 and decreased at follow-up 2 but remained higher than baseline, the low control score was not statistically significant at follow-up 1 (p = 0.20) or at follow-up 2 (p = 0.65).

To understand the level of dementia knowledge, the Dementia Knowledge – 20 scale115 was used at baseline and follow-up 2 only. Within the scale there are two subdomains, dementia core knowledge and dementia care knowledge, with a higher score demonstrating a higher level of dementia knowledge (0–20); however, this was low at baseline, it remained low at final follow-up and there was no significant difference at this time point (p = 0.72).

Sense of competence was measured using the Sense of Competence in Dementia care – Staff questionnaire,116 with a higher score demonstrating a higher perceived rating of competence (17–68). Sense of competence continually increased at follow-up 1 and follow-up 2 and, although not reaching significance at follow-up 1 (p = 0.61), showed statistical difference at follow-up 2 (p = 0.05), indicating that sense of competence significantly increased at final follow-up compared with the control group (Table 19).

TABLE 19

TABLE 19

Secondary outcome measures and statistical significance

Observational study of cognitive stimulation therapy in practice

The design was a multicentre, longitudinal observational study with people with dementia. Sites that were running or in the process of setting up CST groups completed minimal outcome measures at three time points with people with dementia participating in the CST and MCST programme (Figure 17). The measures were completed before the group started (baseline), at 7 or 14 weeks depending on how they implemented the CST programme (once or twice weekly) and after the MCST at 31 or 38 weeks. However, this end time point did differ when taking into consideration staff and group member availability and holidays. The intervention of CST was routinely offered in the care setting. The aim of this study was to determine whether or not groups were running in practice and to determine if the positive findings for cognition and quality of life for the person with dementia found in previous CST research5 could be demonstrated in practice.

FIGURE 17. Flow diagram of observational study and assessment schedule.

FIGURE 17

Flow diagram of observational study and assessment schedule.

Recruitment

Centres that were starting or running CST groups were approached and the staff were asked to complete measures of cognition and quality of life with the people with dementia taking part in the groups. If the staff were unfamiliar with the measures then the researcher agreed to complete the follow-up time points with the people with dementia. The centre type, level of staff experience and training were all recorded. The centres were given the MCST manual and staff training DVD. The recruited participants had a confirmed diagnosis of mild to moderate dementia.

Participants

Centres that were currently running or setting up CST groups were approached to participate in the observational study. It was explained that they would be expected to run the CST and MCST programme. Eleven centres were recruited, with some running more than one programme, providing us with 89 people with dementia. To participate, the people with dementia had to have a score of between 0.5 and 2 on the CDR scale,121 a diagnosis of dementia, adequate spoken and written English, the ability to participate in a ‘meaningful’ conversation and the ability to remain in a group for 45 minutes. The participants also needed to have adequate eyesight and hearing, be able and willing to give informed consent and have the ability to complete a cognitive and quality-of-life measure at three intervals over 1 year. Once between five and eight people with dementia in a centre gave informed consent to complete the minimal outcome measures with a staff member or researcher, the centre was recruited in to the study and a letter explaining their participation in the research was sent to the people with dementia’s general practitioners (GPs). The interviews with people with dementia were carried out by a researcher or staff member who was trained to undertake the assessment and had training in Good Clinical Practice and taking informed consent.

Training package

The staff members in the centres had the CST manual or had previously attended CST training which included the CST manual. To participate in the research programme, in addition to the resources they already had the staff at the centre received the MCST manual and DVD.

Randomisation

No randomisation was necessary, as this was a naturalistic study of CST in practice, so people with dementia who were about to start the CST programme were approached and informed, and their consent was obtained.

Outcome measures

The primary and secondary outcome measures for people with dementia were completed at baseline (time 0) prior to the CST programme starting, and then post CST groups (time 1) (at 7 or 14 weeks depending on whether groups were implemented once or twice weekly). The final follow-up was completed after the MCST had been completed or the programme had ceased running (time 2). Sociodemographic information was collected about the person with dementia, including age, sex, ethnicity, diagnosis of dementia, type of diagnosis and medication. Medication was recorded at each follow-up to mark any differences for the duration of their participation in the trial.

  • The primary outcome was cognition as measured by the MMSE.45 The MMSE has a score of up to 30 points and is widely used as a brief indicator of level of cognitive impairment. It has good reliability and validity.
  • The secondary outcome measure was quality of life as measured by the QOL-AD.89 The QOL-AD is a 13-item scale measuring different aspects of life. The scale totals 52 points and higher scores indicate better quality of life. It has good internal consistency, validity and reliability.122
Consent

Ethics and local R&D approvals were obtained and all participants provided informed consent to participate in the trial. The British Psychological Society’s guidance on the evaluation of capacity was adhered to, as it was in the MCST trial.111

Blinding

Blinding was unnecessary for the staff members and researchers, as each person with dementia had the opportunity to participate in the CST and MCST programme and the staff members or researcher were completing the assessment at each time point.

Analyses

Analysis was a pre–post analysis based on intention to treat, in that all collected data made available by the person with dementia were included, regardless of whether or not that person completed the programme. Imputation methods such as last observation carried forward are of limited use in dementia, as there is the expectation of gradual decline and that participants will be lost through illness or death. A linear regression model was used when there were missing data to predict the missing value and impute the total when possible. The sample size calculation accounted for the number of people expected to be available at the study end point. All participants were in receipt of the CST and MCST programme. Analysis took into account the evaluation at 24 weeks after CST as the primary end point. The secondary analysis considered the effects immediately following the CST programme. Age, sex, AChEI and baseline scores on the two scales being measured were entered as covariates, together with ‘centre’ entered as a random factor.

Ethics arrangements

Risks and anticipated benefits for trial participants

As per the previous study, no documented harmful side effects from participating in either CST training or the running of the CST and MCST programme were apparent and any SAEs were reported to the chief investigator.

Results
Demographics

The majority of the sample was female (57%) and white (94%), with a mean age of 80 years. Just over half were diagnosed with Alzheimer’s disease (51%), with 17% diagnosed with Alzheimer’s and vascular dementia, 16% diagnosed with vascular only and the remaining 16% diagnosed with another type of dementia or unknown. Approximately two-thirds were on dementia medication (62%), with 35% accessing the CST groups through a memory clinic (35%), although overall 91% were in a specialist dementia setting (Table 20).

TABLE 20

TABLE 20

People with dementia demographics (n = 89)

If the CST programme was adhered to twice weekly and followed up immediately with the MCST programme, a person would be expected to participate for 7 months and 21 days. For the centres that delivered the CST twice weekly, the amount of time spent in the trial (from baseline to final follow-up assessment) ranged from 7 months and 23 days to 9 months and 6 days. When the CST programme was run once weekly and followed up with the MCST programme, a person would be expected to participate for 9 months and 14 days. The amount of time participants spent in the trial ranged from 8 months and 27 days to 12 months and 29 days. The variation in time was accounted for by practical issues such as time constraints, lack of staffing, transport difficulties or lack of group members.

Cognition

Cognition as measured by the MMSE45 remained stable over the time frame of the CST and MCST programme. At baseline, 89 participants ranged in score from 7 to 30, with a mean score of 21.2. At follow-up 1, 62 participants ranged in score from 10 to 29, with a mean score of 22. At follow-up 2, 55 participants ranged in score from 4 to 30, with a mean score of 21.4 (Table 21).

TABLE 21

TABLE 21

Details of participants’ cognition

A paired sample t-test was conducted to evaluate the impact of CST on cognition at baseline and final follow-up scores. There was no statistical significance difference in MMSE scores from baseline (mean = 21.36, SD 4.9) to final follow up (mean = 21.42, SD 5.68) [t = –0.138, p = 0.891 (two-tailed)]. The mean increase in the MMSE scores was 0.06 with a 95% CI ranging from –0.85 to 0.74. The eta-squared statistic (–0.14) indicated no effect size (Table 22). A paired sample t-test was also conducted between baseline and follow-up 1; however, there was no statistical significance between time points (p = 0.16).

TABLE 22

TABLE 22

Paired t-test of participants’ cognition

Quality of life

Quality of life as measured by the QOL-AD 89 increased slightly over the time frame of the CST and MCST programme. At baseline, 89 participants ranged in score from 0 to 49, with a mean score of 35.7. At follow-up 1, 62 participants ranged in score from 24 to 49, with a mean score of 36.8. At follow-up 2, 56 participants ranged in score from 25 to 47, with a mean score of 36.7 (Table 23).

TABLE 23

TABLE 23

Details of participants’ quality of life

A paired sample t-test was conducted to evaluate the impact of CST on quality of life at baseline and final follow-up score. There was no statistical significance difference in QOL-AD scores from baseline (mean 36.34, SD 7.63) to final follow-up (mean 36.7, SD 5.3) [t = –0.43, p = 0.667 (two-tailed)]. The mean increase in the QOL-AD scores was 0.39 with a 95% CI ranging from –2.21 to 1.43. The eta-squared statistic (–0.00) indicated no effect size (Table 24).

TABLE 24

TABLE 24

Paired t-test participants’ quality of life

Discussion

This project pragmatically evaluated the effectiveness of staff training and outreach support by increasing the delivery of CST in practice by outreach support intervention in both new (STANDOUT trial) and experienced (MONOU trial) CST practitioners. The MONOU trial provided a naturalistic evaluation of the benefits of manual only versus manual and training in CST implementation, and both the STANDOUT and MONOU trial identified staff and situational factors that impeded or facilitated CST implementation. It also allowed the research to demonstrate, on a large scale, the knowledge, views and understanding, and approach of staff members to dementia in a variety of care settings nationwide with the secondary outcome measures.

As outreach support was rarely accessed, it may seem unsurprising that there was no statistical difference in the delivery of the CST programme between the intervention and TAU groups. However, this study shows similar uptake of CST (one in three) to that in the previously conducted pilot study110 after 1-day training for the STANDOUT trial. There was an increase in both the intervention group (51%) and the TAU group (43%), compared with the 33% reported in the pilot study. This indicated that the outreach support increases the uptake of CST; however, it may be that research involvement inflated this figure also, as when the centre enrolled in the study they agreed to intend to implement the programme. One might expect this initial effort to have dwindled by the time of implementing the MCST programme but this study demonstrates that, with the additional outreach support, the centres were more likely to run MCST following on from the original programme.

The secondary outcome measures provided a useful overview of staff perceptions and knowledge before, during and after the research study, and there was an indication that the intervention improved staff sense of competence. However, it is important to consider the situational factors that impeded the running of the CST and MCST programme. In particular, staff left posts because of restructuring, left their current post or retired, or there was a lack of staff or a lack of suitable participants when considering the inclusion criteria or the time frame of the study. There was a higher than expected dropout rate that could be attributed to these reasons; however, another reason was that staff who did not run the programme felt that it was unnecessary to complete the questionnaire or staff did not have enough time to complete it. On reflection the questionnaire could have been shortened in attempt to maintain a higher retention rate.

In relation to the observational study, it provided an evaluation of long-term cognitive and quality-of-life benefits of CST and MCST in practice. It is the first study to measure outcome measures with people with dementia when only staff members are delivering CST and MCST as part of usual care. Although there were no statistically significant differences from baseline to final follow-up in either cognition or quality of life, the scores remained stable over the time frame of the programme. This is useful as previous research has suggested a decrease of 2–4 points on the MMSE over time frame of a year and a half.123

Although this study looks at groups in practice, and this was reflected in the time frame of the follow-ups, it would be useful to conduct a trial in which staff members in centres emulated the time frame the researchers followed in previous work111 so that it would be possible to make a direct comparison.

Conclusions

In conclusion, the project has attempted to demonstrate the potential benefits of offering outreach support to dementia care staff across a variety of settings. There is no statistical difference between the intervention and TAU groups in running CST. However, those in the intervention group were more likely than those in TAU to go on to run MCST. Positively, in the delivery of CST no groups were considered poor, with all in the OK–good range (≥ 3 group members) and the majority in the latter category. However, this rating did diminish slightly for the MCST programme, for which the majority were in the OK range. There were more groups run among the staff recruited as part of the MONOU trial, and this could be attributed to the staff’s prior experience in delivering CST making them more adept at running the programme.

There was no significant difference in secondary outcome measures when comparing the intervention group with TAU, apart from the staff members in the intervention group at final follow-up considering themselves more competent. It is a positive finding that staff in receipt of outreach support consider themselves more competent, although it would also be useful to develop a measure to determine if this is evident in practice.

With regard to the observational study, there may not have been an improvement in cognition and quality of life over the duration of the programme; however, maybe just as importantly, there was no deterioration in scores either. This is important as the CST originally designed to be run twice weekly was also implemented once weekly and this did not affect the cognition and quality-of-life scores. A future trial would be useful to control the frequency in delivery of the CST, the time frame of completing the assessment time points and the rigorousness of the inclusion criteria required to participate in the programme.

Overall, this study has made a positive step towards demonstrating the benefits of offering outreach support to staff in delivering CST as part of their usual practice. Although the support may not be able to overcome the wider factors that might impede the successful delivery of the programme, such as organisational change, it does appear to build on the staff members’ perceived levels of competence and increase the delivery of the MCST programme following on from the original programme.

Focus groups about the experience and effect of maintenance cognitive stimulation therapy

Three focus groups were undertaken with people with dementia taking part in the observational study and the staff facilitating these sessions. The results were originally written up by Priyanka Chauhan, a BSc (Bachelor of Science) psychology student supervised by Professor Martin Orrell, entitled ‘The experience and effect of Maintenance Cognitive Stimulation Therapy (maintenance CST): The perspective of people with dementia and maintenance CST group facilitators’. However, the focus groups were co-run and supported by a researcher (Amy Streater) as part of the SHIELD programme.

Aim

The study explored the experiences and effects of participating in the MCST programme by conducting semistructured interviews with people with dementia and CST facilitators. It also aimed to explore the mechanisms of change and compare the findings with those of a previously conducted study110 on the experiences of CST to determine if the MCST continued the perceived benefits identified from the original programme.

Sample

Ten people with dementia who had completed the CST programme and were part way through the MCST programme were recruited from an East London community day centre for older people. The mean age was 84 years and the sample was made up of four male and six female participants. There was a mean baseline MMSE45 score of 16, indicating a moderate level of impairment. All had completed the CST programme and were up to the sixth MCST session.

Five staff members were recruited that had previously acted as a cofacilitator or main facilitator in running the CST programme and were in the process of running the MCST programme with the people with dementia recruited into the study. The day centre was purposefully chosen as it had previously been enrolled in the MCST research project111 and staff had gone on to run their own groups following on from the research, it was considered that the staff were experienced enough to provide an in-depth experience of the MCST programme. The staff members either had attended the CST training day or had the CST ‘Making a difference’ manual. All staff members were female and between them they had an average of 11 years of dementia care experience.

Inclusion criteria

People with dementia were initially approached if they had completed the CST programme and regularly attended the MCST programme that was currently under way at the centre. However, they also needed to (1) have met the DSM-IV124 criteria for dementia, (2) have scored between 10 and 24 on the MMSE,45 (3) be able to adequately communicate, (4) see and hear well enough to participate in the group, (5) not present behaviour or have a physical illness that could limit their participation, and (6) not have a diagnosis of a learning disability. These inclusion criteria were used to ensure that people could adequately participate and provide useful information in the focus group.

The staff members were considered eligible to participate in the focus group if they had participated in the running of the CST and MCST programme and met with the service users accessing CST at least twice weekly; this was considered sufficient time for staff to be familiar enough with the service users that they could comment on everyday effects that might arise from the MCST programme.

Procedure

Managers were approached 1 month before the focus groups were undertaken to gauge their level of interest and identify potential participants from both staff and people with dementia. A week prior to the focus groups being undertaken, a researcher approached the staff and people with dementia and went through the information and consent form, allowing any questions to be asked. The researcher went through the information sheet and consent form again on the day of the focus group and discussed this with the participant for a second time before informed consent was obtained. Consent was obtained in accordance with the British Psychological Society40 guidelines and ongoing consent was adhered to; participants were reminded that they could withdraw at any time and no adverse consequences would result from this.

Materials

A discussion guide was devised, based on the findings from a previous study,110 to guide the conversation. This allowed a reliable comparison to be made between the person’s MCST experience and the original CST programme. Questions were created with the aim of understanding any mechanisms of change that might be occurring; this was in relation to a person-centred approach (PCA).125 Swaab’s theory of stimulating underused cognitive ability126 and the biopsychosocial model127 were explored. All focus groups were audio-taped and field notes were taken by a cofacilitator to document any useful non-verbal communication and interaction of group members that might have been lost in the transcription stage of the data analysis.

Data analysis

The data analysis followed the stages of framework analysis128 and followed the principles of thematic content analysis.129 Each focus group transcript was analysed with the following steps: (1) immersion in the data; (2) categorising the data to identify a thematic framework; (3) coding; and (4) interpretation and association. In the first stage it consisted of the researcher familiarising himself or herself with the general ideas generated from the focus group discussion that were identified from reading the transcripts. In stage 2, ‘open coding’130 was used to categorise the data into general themes, followed by themes more representative of the data. To ensure the validity of the themes, a second researcher also analysed the transcripts so that a final set of themes was agreed by both researchers. The third stage involved the coding of the transcripts in accordance with the thematic framework and this was then followed by the final stage of interpreting the findings in accordance with the existing literature.

Results

After the data were analysed, two main themes emerged across the three focus groups. The first was ‘positive experiences of being in the group’ including the subthemes ‘enjoyable company’, ‘positive feelings’ and ‘benefits of a smaller group’. The second theme identified was ‘cognitive stimulation and cognitive benefits’, with the subthemes ‘importance of and improvement in communication’, ‘importance of variety’ and ‘improvements in memory’.

In the following quotations, to clarify who was speaking, P will be used to identify a person with dementia and S will be used to identify a staff member.

Positive experiences of being in the group
Enjoyable company

People with dementia emphasised the building of relations resulting from their participation in the programme and time spent with others as key reasons that they enjoyed the sessions. They openly expressed their enjoyment and appreciation of interacting with others, including the staff.

It’s nice to have a group, it feels like you’ve got friends.

P

Current affairs was discussed as being the most enjoyable activity (see Importance of conversation); however, people with dementia were receptive to all of the activities in the programme and emphasised that the company of others was the primary reason that the sessions were enjoyable.

I’m never bothered about what they are going to discuss, I can be a listener as well as a talker . . . when I’m with people the atmosphere does me.

P

Positive feeling

People with dementia often reported feelings of happiness and feeling lifted and more relaxed. Some also mentioned that they could recall the MCST session later when they were at home, demonstrating lasting effects beyond the group itself.

It’s nice, when you get indoors you’re relaxed and in your mind you can see it all over again. You’re doing it all over again in your mind, you relive it.

P

Another repeated positive feeling was that of being valued and comfortable.

Nobody’s taking the quiet mick out of anybody.

P

Staff members also noted that the group members felt a sense of inclusion and that the attendees highlighted the group they attended as ‘theirs’.

They ask each other ‘Which group are you going?’ and he says ‘No, no, no, I’m going to my own group, this is my own group’.

S

Benefits of a smaller group

Staff members felt that the larger group size usually used for activities in the day centre (group size of 12) would not generate the positive feelings demonstrated by the CST group members. Having a group size of between five and eight people facilitated the positive feelings. People with dementia were also aware of the difference in numbers.

She’s allowed to say what she wants to say. I think because it’s a smaller and it’s a happy group as we say.

S

When we amongst a lot of others (common areas), it’s not the same.

P

However, the point was made that a balance had to be struck in terms of group size so that groups did not get too small with the potential to bring in new members.

We’ve been so small we haven’t diversified a lot. I’d like to see us know get more people in here so discussions become more broad and diversify.

P

Cognitive stimulation and cognitive benefits
Importance of and improvement in communication

Both staff members and people with dementia believed that cognitive stimulation occurred through discussion. Discussion is one form of cognitive stimulation with the MCST programme, as it helps to facilitate the learning of new information and allows people to express their opinions. All participants rated a session theme entitled ‘Current affairs’ the most enjoyable.

It is nice to hear other people’s opinion, you think to yourself, ‘Oh I never thought of that’. It livens you up.

P

You can develop some sort of discussion and people will join in it, irrespective whether they like it or not, and that gives a feeling that they appreciate you and don’t want to decline what you’re saying.

P

Staff members noticed improvements in people with dementia’s ways of expressing themselves and identified an increase in their willingness to communicate and participate in the MCST group.

She never used to say much, but in the group she’s got loads to say, I just have to sit back and listen to her, just going on and on and she won’t stop you know.

S

She’s thinking about things and more confident about expressing her opinions.

S

Importance of variety

The staff members clearly felt that cognitive stimulation occurred owing to the range of activities and discussion topics available and raised the idea that the variety of sessions would be key to the continuing success of the MCST programme. The service users also emphasised the importance of flexibility and choice within the programme that would not be possible without there being a variety of sessions.

You’ve got different sections to it, you’ve got the reminiscence you know, you’ve got the newspapers, you’ve got the activities so even if there is something that they are not interested in the activities, but you might find that they would have a lovely discussion during the newspaper reading. There is always something for someone.

S

They [staff] allow a free discussion . . . it creates a good atmosphere, it gives people confidence then to talk.

P

Improvement in memory

Both service users and staff reported that the sessions aided recall and led to specific improvements in memory, such as the repetition of the group song or orientation to the current time and place.

They didn’t even know the road that the day centre was on . . . now as soon as we sit down . . . they can tell you the resource centre, [road name], even the postcode now.

S

I’m using it more . . . I was becoming really as if I had no memory at all. Since coming here it’s revived it all.

P

Discussion

This study aimed to explore the experiences and effects of the MCST programme for people with dementia and the perceptions of the facilitators. It also looked to identify possible mechanisms for change and to see if the findings of this study were comparable with the themes identified in the CST programme,110 to see if the MCST programme sustains the positive experiences and effects when it follows on from CST. The identified themes indicate that there is a similarity between the experiences and effects of CST and those of the MCST programme, and each theme ties into at least one of the mechanisms of change explored: Kitwood’s PCA,125 Swaab’s theory of stimulating underused cognitive abilities126 and the biopsychosocial model.127

Comparison with Spector et al.110 CST findings

The first theme identified was ‘positive experience of being in the group’, which was identified in the previous study. Within this theme, ‘positive feeling’ was also found in the 2011 study and within this were feelings of enjoyment, relaxation and something to look forward to. The second subtheme, ‘enjoyable company’, corresponds to the identified subtheme in the previous study of ‘supportive and non-threatening environment’, as both recognise the positive effects of relationship building between group members and with the facilitators. A difference in the main theme between this study and that by Spector et al.110 is that the latter did not find the subtheme of ‘benefits of a smaller group’ and this study did not report the service users gaining and remaining confident for the remainder of the day after CST. However, the increase in confidence for people with dementia had been identified through their family caregivers and, as this demographic was not used in this study, it cannot be assumed that this is different for the MCST programme. However, it is important to note that staff members noticed that for some people with dementia their increased confidence outside the group could be considered evidence of their enhanced confidence (see Importance of and improvement in communication).

Two of the subthemes, ‘cognitive stimulation and cognitive benefits’ and ‘importance of and improvement in communication’, tally with the subtheme ‘positive experience of being in the group’ as identified in the 2010 study. Within this were the subthemes ‘finding it easier to talk’ and ‘sharing a diagnosis’, which can be considered reasons for improvement in communication. An increase of confidence in communication ties in with the first theme of ‘positive experience of being in the group’, as comfort in a smaller group size, valued contributions and friendship can lead to a heightened confidence in expressing oneself. The corresponding subthemes demonstrate that the opportunity that is created in CST to discuss, give and receive opinions is a factor in the perceived success of the CST and MCST programme. It would seem unlikely that conversation would have been an important element without having ‘positive feelings’ and the ‘benefits of a smaller group’. The importance placed on opinion links into the CST key principles of opinion over fact and implicit learning, both of which fall under ‘positive person work’ (PCA). Placing value on what people say rather than on the factual content or accuracy of what they say increases their confidence in expressing their opinion. The subtheme ‘importance of variety’, under the main theme of ‘cognitive stimulation and cognitive benefits’, did not correspond to the Spector et al.110 study, yet it was a key point of agreement in this study (see Mechanisms of change); however, this might be have been emphasised owing to the extended duration of the MCST programme.

Both a general and a specific improvement in memory were identified in Spector et al.110 and in this study. It could be argued that ‘improvement in memory’ resulted from the use of reality orientation,131 as a result of the reality orientation board used for every CST and MCST session and the repetitiveness of the implicit information processing (group name, song, location) as well as the session structure as presented in both the CST and MCST manual. This can be related to the subtheme of ‘positive experience of being in the group’, as one might expect that, without an environment conducive to participation and enjoyment, the likelihood of someone becoming actively involved in the discussion and activities might decrease and, in turn, lead to a negative impact on their memory and cognition.

Mechanisms of change

An analysis of the mechanisms of change was necessary to develop an understanding of what is effective in relation to CST. Two of the themes emerged in this study, ‘benefits of a smaller group’ and ‘importance of variety’, that can be considered mechanisms of change. As both the Spector et al.110 and this study identified ‘positive experience of being in a group’ as a theme, it is apparent that both the CST and MCST programmes created an environment that facilitated ‘positive feelings’ of value and inclusion as well as the building of relationships. This theme is evidence of the benefits of using a PCA.125 A PCA places emphasis on seeing the person with dementia as a person and an individual, rather than defining them according to their diagnosis.

The ‘benefits of a smaller group’ subtheme appears to fit well as part of a PCA125 as it encourages more in-depth relationships, something one might expect to be harder with a larger group . The possibility of developing friendships in a small group might encourage the active participation of each group member and increase the cognitive benefits of CST.126 So, although a larger group might adhere to the same principles, it may not demonstrate the same benefits for the group members.

The variety of activities and current affairs to be discussed at the beginning of each session follows another key principle of CST: choice. Allowing choice reiterates that the group belongs to the group members and increases the chance of catering to each person’s needs and interests, further facilitating the use of a PCA. The flexibility of variety is in keeping with the biopsychosocial model,127 which states that treatment should consider the fixed biological factors as well as the changeable psychological and social factors when working with a person with dementia. This model works with CST as it identifies the fixed factors that are reflected in the inclusion criteria of the therapy of scoring 10–24 on the MMSE,45 as well as the tractable factors such as sensory impairment when it is necessary for the person with dementia to see and hear well enough to participate in the programme.6 The biopsychosocial model does link in with the inclusion criteria used for participation in the programme but it is more strongly related to the psychological factors as recognised in the model. CST as a psychosocial intervention creates a social support network through the group format of the therapy leading to improvements in social relations and uses a multisensory stimulation through the session themes and materials to encourage implicit mental stimulation (psychological tractable factor). An understanding of the person’s history, personality and beliefs before starting CST emphasises a PCA as this can be considered when running discussion or activities. The variety offered by CST also allows for personal psychology and individual differences to be taken into account when creating sessions that can cater for a range of interests.

Limitations

The study focused on the opinions generated from the people with dementia participating in the programme as well as those of the staff members facilitating the groups. As the staff members were familiar with the service users, it was not considered necessary to include family members. However, when conducting the focus group, staff did not feel comfortable commenting on the possible after-effects of MCST. Staff might also be unaware of the person with dementia’s feelings about the group, whereas the service user might be more open with a family member about their experiences. So, focus groups run with family members might be useful when considering the after-effects and a more in-depth understanding of the perceptions of the MCST programme.

Owing to the limited time frame of the study the focus groups were conducted after the sixth session of MCST. The full maintenance programme is run over 24 weeks so the opinions expressed were after one-third of the programme had been delivered. It could be considered that focus groups conducted at the end of the MCST programme would be more beneficial in getting a truer account of the experience of the programme, as in the study the people with dementia could discuss the experience of the first six sessions only. This point might not be as relevant to the staff as they were able to draw on their previous experience of the MCST programme, having delivered it prior to the current group.

As there was a time constraint on collecting the data, only one centre could be recruited into the study. This might have biased the results as the feedback on the MCST programme was specific to the delivery of it in that particular centre. There was also a small number of participants (10 people with dementia and five staff members) and so the amount of feedback was limited to a small sample size. However, the same thoughts about the programme were mentioned across the three groups, so it might be that more participants would not necessarily generate any additional themes but rather would strengthen those already identified in this study.

Conclusion

This study used focus groups to explore the experience and effect of MCST with people with dementia and staff members, and in addition looked at the mechanisms of change and compared the findings with those of a previously conducted study on service users’, family members’ and staff members’ experience of CST.110 This study identified that the experience of MCST closely matched the experience of CST and that MCST appears to preserve the perceived benefits across the duration of the programme. The main themes identified were ‘positive experience of being in the group’ and ‘cognitive stimulation and cognitive benefits’, and both of these can be indirectly related to one of the mechanisms of change (PCA and benefits of a small group). Further research is required to look further at the mechanisms of change identified in both quantitative and qualitative methods and relate this to CST and MCST to determine what is most important in attempting to further understand and increase the benefits for people with dementia.

Copyright © Queen’s Printer and Controller of HMSO 2017. This work was produced by Orrell et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

Included under terms of UK Non-commercial Government License.

Bookshelf ID: NBK424178

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