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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.)

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

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

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Chapter 1Introduction

Background

Dementia is very common in old age and the frequency of dementia increases with age, from around 5% in those aged > 65 years to around 20% in those aged > 85 years.1,2 In the UK there are 850,000 people living with dementia3 which leads to progressive intellectual deterioration, increasing disability and social exclusion.4 This has an enormous social and economic impact on health and social care services, and on family carers. There is little high-quality research on the effectiveness of psychological and social interventions, and there is an urgent need to find more useful interventions to help reduce the impact of dementia on people with dementia, carers and society. Drug treatments have an important role in dementia care, but in the UK they are limited to people with Alzheimer’s disease, with mild to moderately severe dementia, have a limited impact on the illness, are not suitable for all patients and cost approximately £1000 per year.5 There is increasing recognition that psychological and social interventions may have comparable value6 and may be preferable (e.g. when medication may have intolerable side effects).7

In the UK there is recognition that psychological therapies for older people should be more widely available, and the National Service Framework for Older People4 states that ‘treatment for dementia always involves using non-pharmacological management strategies such as mental stimulation’ (contains public sector information licensed under the Open Government Licence v3.0). However, the delivery of such therapies has been generally unstandardised, and many evaluations of psychological treatments have been either small or of poor methodological quality, or both. A number of systematic reviews of psychosocial interventions are now available,810 as well as a number of Cochrane reviews on interventions with a cognitive focus.11,12 Cognitive stimulation therapy (CST) is an evidence-based approach which has been shown to be beneficial to cognitive function and quality of life, and also cost-effective.6,13 Indeed, the recent draft National Institute for Health and Care Excellence (NICE) guidelines on dementia14 recommend that all people with mild to moderate dementia should be ‘given the opportunity to participate in a structured group cognitive stimulation programme’.

In the UK, reminiscence work with people with dementia has an extensive history;15,16 it involves enjoyable activities that tap into early memories and encourage communication and well-being. However, its popularity has not led to a corresponding body of evidence on its effects. The Remembering Yesterday, Caring Today (RYCT) trial platform suggested that it was useful to involve family carers in reminiscence groups with people with dementia, and a recent meta-analysis of outcomes for family caregivers confirms that involving people with dementia and their carers together is more effective than working with carers only.10 Over the last decade, the needs of carers have remained a high priority, with a national strategy published in 1999.17 Being a family carer is stressful and a recent study showed that one in three carers had a mental illness.18 The carers of people with dementia experience greater strain and distress than the carers of other older people.19 The Expert Patients Programme for people with long-term conditions aims to increase their confidence, improve their quality of life and better manage their conditions.20 In a 2006 White Paper21 the government pledged funding for the creation of an Expert Carer Programme, which would include training to develop carers’ skills in addition to self-care skills of people with dementia. The progressive decline and the changing nature of dementia over time mean that family carers’ needs will change.22 There is an evidence base for cognitive–behavioural packages being the predominant approach for psychoeducation, stress and behaviour management, with principles and basic components that could be disseminated for use by non-therapists. For example, in caring for a person with dementia, sessions may include coping with the psychological and behavioural symptoms of dementia.

In the last few years there has also been an increasing emphasis on maintaining older people with dementia at home, rather than admitting them to hospital, to help to maintain their independence and quality of life. The document Everybody’s Business: Integrated Mental Health Services for Older Adults23 advised that community mental health teams (CMHTs) for older people needed to have some provision for 24-hour home-based crisis support, and Raising the Standard: Specialist Services for Older People with Mental Illness24 highlighted the need for alternatives to inpatient care. A 2005 review25 noted the lack of evidence for alternatives to acute psychiatric admissions for older people and another study from the same year indicated that home treatment teams (HTTs)/crisis teams are effective at reducing admissions for those aged < 65 years.26 There are suggestions that this approach may also reduce admissions for those aged > 65 years with mental health problems,27,28 including people with dementia.

Aims and objectives

The aim of this research programme is to prevent excess disability, promote social inclusion, improve health outcomes and enhance the quality of life of people with dementia and their carers. The aim was achieved by a rigorous 5-year programme of psychosocial research building on our existing work in cognitive stimulation, reminiscence work and carer support, and also by a new initiative developing intensive home support to manage crises at home and prevent admission to hospital for people with dementia.

Cognitive stimulation therapy is an evidence-based approach which has been shown to be beneficial to cognitive function and quality of life, and also cost-effective. As the degree of cognitive benefit from CST is similar to that from cholinesterase inhibitors, longer-term CST may have an impact on long-term care.

Reminiscence work with people with dementia taps into early memories and encourages communication and well-being, and a recent meta-analysis indicated that involving people with dementia and their carers is more effective than working with carers only. Our trial platform successfully developed a manual for joint reminiscence, RYCT, and suggests that RYCT improves the caring relationship and benefits both people with dementia and carers. Our experience from the Befriending and Costs of Caring (BECCA) programme29 showed that many ex-carers are motivated to support others at an earlier stage in their role as a family carer, through mentoring and teaching.

There is some evidence that HTTs may reduce admissions for people with dementia; however, better evidence for their effectiveness is required before wider implementation is considered.

This research programme provides essential evidence to clarify the role of each of these interventions in helping to support people at home, reducing hospital and care home admissions, and improving the quality of life of people with dementia and their carers.

The three projects are (1) cognitive stimulation groups for people with dementia to improve their cognition and quality of life, (2) a new initiative called the Expert Carer Programme, which trains ex-carers to help new carers of people with dementia and was undertaken alongside reminiscence groups for people with dementia and their carers which help to maintain quality of life and improve their relationships, and (3) the development of intensive home support to help manage crises at home and prevent admission to hospital for people with dementia.

Each of the three projects completed a number of components of the pathway through development of theory, modelling, feasibility and evaluation to dissemination and implementation, as illustrated in the Medical Research Council (MRC) framework for complex interventions.30

All of these approaches were carefully evaluated to look at their potential benefits to people with dementia and their carers. We have also produced training manuals which will be made widely available to help other services implement the same approaches.

Objectives

  1. To develop a model to identify the most promising interventions and components for an effective home treatment package (HTP) for dementia.
  2. To carry out systematic reviews in the areas of home treatment for dementia and to update the Cochrane review on reality orientation/CST for dementia.
  3. To develop a HTP for dementia and a package for carer supporters.
  4. To carry out a pilot study for (a) the reminiscence and carer programmes separately and in combination, and (b) the effectiveness of maintenance CST (MCST) with donepezil.
  5. To provide definitive randomised controlled trials (RCTs) for MCST, RYCT and the Carer Supporter Programme (CSP).
  6. To conduct in-depth field testing of the HTP for dementia.
  7. To conduct a post-RCT surveillance study of MCST in practice, including minimal outcome measures and qualitative approaches.
  8. To provide economic evaluations for the MCST and CSP/RYCT interventions.
  9. To involve users, carers and the voluntary sector, and to develop a model of user/carer involvement that can be widely used.
  10. To develop training and manuals for all three interventions.
  11. To disseminate service models, training programmes, tools and outcomes.

This report outlines the work undertaken for each project and individual aims and objectives for each study are given in their respective chapters. The development of the interventions focuses on the involvement of service users and key stakeholders.

User and carer involvement

User and carer involvement is now central to research and development (R&D) strategy in health and social care nationally, and their involvement is required as a condition of funding.31 User involvement and collaboration has been found to improve the quality, depth and utility of research.32,33 We developed a strategy for user and carer involvement as part of the SHIELD (Support At Home – Interventions to Enhance Life in Dementia) research programme.34 The strategy encompassed principles of good involvement practice (i.e. clarity and transparency, respect, diversity, flexibility and accessibility) and meaningful involvement.35 Service users and carers were involved in consensus workshops, focus groups and consultation processes for developing interventions to ensure their relevance and acceptability. User involvement can help develop more theoretically coherent and evidence-based interventions, which are more likely to be practical, generalisable and meaningful for potential users.36 Carers were also involved in the recruitment of staff and provision of training and as part of the SHIELD research programme steering and monitoring committees.

Ethics arrangements and research governance for the SHIELD research programme

All projects obtained ethics approval from a NHS Research Ethics Committee and local R&D approvals for all sites involved in the research. Amendments to protocols were made and approvals were sought from ethics committees as needed throughout the research programme. The trial was sponsored by University College London and North East London Foundation Trust (NELFT). Our Programme Steering Committee consisted of an independent chairperson and external committee members comprised interested clinicians, academics, voluntary sector staff and service users, as well as the grantholders and key individuals from the research programme (see Acknowledgements).37 A Data Monitoring and Ethics Committee was created as a subcommittee of the Programme Steering Committee. This group consisted of an independent academic as chairperson, an independent statistician and a family carer37 (see Acknowledgements).

Consent

Informed consent was sought whenever appropriate. Participants were at various stages of dementia ranging from mild to moderate, to severe. Some participants were competent to give informed consent for participation, provided that appropriate care was taken in explaining the research and sufficient time was allowed for them to reach a decision. However, those people with more advanced dementia were also included and, in these situations, the provisions of the Mental Capacity Act were followed.38,39 It was helpful for a family member or other supporter to be involved, and we aimed to ensure that this was done whenever possible. It was made clear to all that no disadvantage would accrue if they chose not to participate. In seeking consent, we followed current guidance from the British Psychological Society40 on the evaluation of capacity; thus, consent was regarded as a continuing process rather than a definitive, and willingness to participate was continually checked through discussion with participants during the assessments. When a participant’s level of impairment was more severe or increased so that they were no longer able to provide informed consent, the provisions of the Mental Capacity Act were followed.38,39 The initial giving of informed consent provided a clear indication of the person’s likely perspective on continuing at this point, and the family caregiver was consulted in this regard. If a participant with dementia became distressed during the assessments, the assessments were discontinued.

Adverse events

Prospective participants were fully informed of the potential risks and benefits of the projects they were recruited to. A reporting procedure was in place to ensure that serious adverse events (SAEs) were reported to the chief investigator (MO).41 On becoming aware of an adverse event involving a participant or carer, the research programme co-ordinator (JH) assessed its seriousness. A SAE was defined in the trial as an untoward occurrence experienced by either a participant or a carer which resulted in death; was life-threatening; required hospitalisation or prolongation of existing hospitalisation; resulted in persistent or significant disability or incapacity; was otherwise considered medically significant by the investigator; or was within the scope of the Protection of Vulnerable Adults protocol.41 A reporting form was submitted to the chief investigator, who assessed whether or not the SAE was related to the conduct of the trial and was unexpected. If SAEs were judged to be related and unexpected, they were reported to the Multicentre Research Ethics Committee and the trial Data Monitoring and Ethics Committee.

Changes from the planned protocol

National Institute for Health Research (NIHR) funding for SHIELD was received in August 2007 and the research programme commenced in February 2008. The original scope of the programme was to undertake four trials examining the effectiveness of MCST programmes, the implementation of MCST in practice, RYCT and the CSP, and a HTP for dementia. Time and budgetary constraints meant that we were advised by the NIHR review team not to complete a trial of the home treatment intervention. This will now be tested in a further NIHR-funded trial. All studies followed the MRC guidance for developing and evaluating complex interventions.30

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: NBK424171

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