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Cover of Group cognitive–behavioural programme to reduce the impact of rheumatoid arthritis fatigue: the RAFT RCT with economic and qualitative evaluations

Group cognitive–behavioural programme to reduce the impact of rheumatoid arthritis fatigue: the RAFT RCT with economic and qualitative evaluations

Health Technology Assessment, No. 23.57

, , , , , , , , , , , , , , and ; on behalf of the RAFT Study Group.

Author Information
Southampton (UK): NIHR Journals Library; .

Headline

CBT plus usual care, delivered by clinical rheumatology teams, reduced fatigue impact in rheumatoid arthritis at 26 weeks beyond usual care alone, but with uncertain cost-effectiveness.

Abstract

Background:

Fatigue is a major problem in rheumatoid arthritis (RA). There is evidence for the clinical effectiveness of cognitive–behavioural therapy (CBT) delivered by clinical psychologists, but few rheumatology units have psychologists.

Objectives:

To compare the clinical effectiveness and cost-effectiveness of a group CBT programme for RA fatigue [named RAFT, i.e. Reducing Arthritis Fatigue by clinical Teams using cognitive–behavioural (CB) approaches], delivered by the rheumatology team in addition to usual care (intervention), with usual care alone (control); and to evaluate tutors’ experiences of the RAFT programme.

Design:

A randomised controlled trial. Central trials unit computerised randomisation in four consecutive cohorts within each of the seven centres. A nested qualitative evaluation was undertaken.

Setting:

Seven hospital rheumatology units in England and Wales.

Participants:

Adults with RA and fatigue severity of ≥ 6 [out of 10, as measured by the Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scale (BRAF-NRS)] who had no recent changes in major RA medication/glucocorticoids.

Interventions:

RAFT – group CBT programme delivered by rheumatology tutor pairs (nurses/occupational therapists). Usual care – brief discussion of a RA fatigue self-management booklet with the research nurse.

Main outcome measures:

Primary – fatigue impact (as measured by the BRAF-NRS) at 26 weeks. Secondary – fatigue severity/coping (as measured by the BRAF-NRS); broader fatigue impact [as measured by the Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ)]; self-reported clinical status; quality of life; mood; self-efficacy; and satisfaction. All data were collected at weeks 0, 6, 26, 52, 78 and 104. In addition, fatigue data were collected at weeks 10 and 18. The intention-to-treat analysis conducted was blind to treatment allocation, and adjusted for baseline scores and centre. Cost-effectiveness was explored through the intervention and RA-related health and social care costs, allowing the calculation of quality-adjusted life-years (QALYs) with the EuroQol-5 Dimensions, five-level version (EQ-5D-5L). Tutor and focus group interviews were analysed using inductive thematic analysis.

Results:

A total of 308 out of 333 patients completed 26 weeks (RAFT, n/N = 156/175; control, n/N = 152/158). At 26 weeks, the mean BRAF-NRS impact was reduced for the RAFT programme (–1.36 units; p < 0.001) and the control interventions (–0.88 units; p < 0.004). Regression analysis showed a difference between treatment arms in favour of the RAFT programme [adjusted mean difference –0.59 units, 95% confidence interval (CI) –1.11 to –0.06 units; p = 0.03, effect size 0.36], and this was sustained over 2 years (–0.49 units, 95% CI –0.83 to –0.14 units; p = 0.01). At 26 weeks, further fatigue differences favoured the RAFT programme (BRAF-MDQ fatigue impact: adjusted mean difference –3.42 units, 95% CI –6.44 to – 0.39 units, p = 0.03; living with fatigue: adjusted mean difference –1.19 units, 95% CI –2.17 to –0.21 units, p = 0.02; and emotional fatigue: adjusted mean difference –0.91 units, 95% CI –1.58 to –0.23 units, p = 0.01), and these fatigue differences were sustained over 2 years. Self-efficacy favoured the RAFT programme at 26 weeks (Rheumatoid Arthritis Self-Efficacy Scale: adjusted mean difference 3.05 units, 95% CI 0.43 to 5.6 units; p = 0.02), as did BRAF-NRS coping over 2 years (adjusted mean difference 0.42 units, 95% CI 0.08 to 0.77 units; p = 0.02). Fatigue severity and other clinical outcomes were not different between trial arms and no harms were reported. Satisfaction with the RAFT programme was high, with 89% of patients scoring ≥ 8 out of 10, compared with 54% of patients in the control arm rating the booklet (p < 0.0001); and 96% of patients and 68% of patients recommending the RAFT programme and the booklet, respectively, to others (p < 0.001). There was no significant difference between arms for total societal costs including the RAFT programme training and delivery (mean difference £434, 95% CI –£389 to £1258), nor QALYs gained (mean difference 0.008, 95% CI –0.008 to 0.023). The probability of the RAFT programme being cost-effective was 28–35% at the National Institute for Health and Care Excellence’s thresholds of £20,000–30,000 per QALY. Tutors felt that the RAFT programme’s CB approaches challenged their usual problem-solving style, helped patients make life changes and improved tutors’ wider clinical practice.

Limitations:

Primary outcome data were missing for 25 patients; the EQ-5D-5L might not capture fatigue change; and 30% of the 2-year economic data were missing.

Conclusions:

The RAFT programme improves RA fatigue impact beyond usual care alone; this was sustained for 2 years with high patient satisfaction, enhanced team skills and no harms. The RAFT programme is < 50% likely to be cost-effective; however, NHS costs were similar between treatment arms.

Future work:

Given the paucity of RA fatigue interventions, rheumatology teams might investigate the pragmatic implementation of the RAFT programme, which is low cost.

Trial registration:

Current Controlled Trials ISRCTN52709998.

Funding:

This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 57. See the NIHR Journals Library website for further project information.

Contents

About the Series

Health Technology Assessment
ISSN (Print): 1366-5278
ISSN (Electronic): 2046-4924

Article history

The research reported in this issue of the journal was funded by the HTA programme as project number 11/112/01. The contractual start date was in November 2013. The draft report began editorial review in June 2018 and was accepted for publication in January 2019. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.

Declared competing interests of authors

Sarah Hewlett’s institution received a grant from Novartis International AG (Basel, Switzerland) after the trial ended, to train rheumatology teams in fatigue management. Ernest Choy’s institution received grants from the Medical Research Council (London, UK) and Versus Arthritis (formerly Arthritis Research UK) (Chesterfield, UK). In addition, Ernest Choy has received grants/consultancy or speaker’s fees from AbbVie Inc. (North Chicago, IL, USA), Bristol-Myers Squibb (New York, NY, USA), Chugai Pharmaceutical Co. (Tokyo, Japan), Eli Lilly and Company (Indianapolis, IN, USA), Janssen: Pharmaceutical Companies of Johnson & Johnson (Beerse, Belgium), Novartis International AG, ObsEva SA (Geneva, Switzerland), Pfizer Inc. (New York, NY, USA), Regeneron Pharmaceuticals, Inc. (Tarrytown, NY, USA), F. Hoffmann-La Roche AG (Basel, Switzerland), R-Pharm JSC (Moscow, Russia), Sanofi SA (Paris, France), SynAct Pharma (Lund, Sweden), Tonix Pharmaceuticals (New York, NY, USA) and UCB Pharma Ltd (Slough, UK). William Hollingworth is a member of the Health Technology Assessment Clinical Trial Board (2016–present).

Disclaimer

This report contains transcripts of interviews conducted in the course of the research and contains language that may offend some readers.

Last reviewed: June 2018; Accepted: January 2019.

Copyright © Queen’s Printer and Controller of HMSO 2019. This work was produced by Hewlett et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. 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.
Bookshelf ID: NBK547568DOI: 10.3310/hta23570

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