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

Autor: Nicholas Ambler, Joanna Thorn, Celia Almeida, Alison Hammond, Clive Rooke, Nicholas Turner, Zoe Plummer, Emma Dures, Peter S Blair, Sarah Hewlett, Bryar Kadir, John R. Kirwan, Jonathan I Pollock, William Hollingworth, Ernest Choy
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Male
Coping (psychology)
Cost-Benefit Analysis
medicine.medical_treatment
law.invention
Arthritis
Rheumatoid
0302 clinical medicine
Occupational Therapy
Randomized controlled trial
law
Medicine
030212 general & internal medicine
Qualitative Research
Fatigue
Randomised controlled trial
Self-management
COST–BENEFIT ANALYSIS
Cost–benefit analysis
Health Policy
Research Support
Non-U.S. Gov't
Cost-benefit analysis
Cognition
Focus Groups
Middle Aged
lcsh:R855-855.5
England
Randomized Controlled Trial
Female
BRTC
Research Article
medicine.medical_specialty
lcsh:Medical technology
Cognitive therapy
BTC (Bristol Trials Centre)
Interviews as Topic
03 medical and health sciences
Internal medicine
Qualitative research
Journal Article
Humans
Rheumatoid arthritis
SELF-MANAGEMENT
RHEUMATOID ARTHRITIS
Aged
Patient Care Team
030203 arthritis & rheumatology
Wales
Cognitive Behavioral Therapy
business.industry
COGNITIVE THERAPY
Rheumatology
Physical therapy
Self Report
RANDOMISED CONTROLLED TRIAL
business
Zdroj: Hewlett, S, Almeida, C, Ambler, N, Blair, P S, Choy, E, Dures, E, Hammond, A, Hollingworth, W, Kadir, B, Kirwan, J, Plummer, Z, Rooke, C, Thorn, J, Turner, N & Pollock, J 2019, ' Group cognitive-behavioural programme to reduce the impact of rheumatoid arthritis fatigue : the RAFT RCT with economic and qualitative evaluations ', Health Technology Assessment, vol. 23, no. 57, pp. 1-166 . https://doi.org/10.3310/hta23570
Hewlett, S E, Almeida, C J, Ambler, N, Blair, P, Choy, E, Dures, E K, Hammond, A, Hollingworth, W, Kadir, B, Kirwan, J R, Plummer, Z E, Rooke, C, Thorn, J, Turner, N L, Pollock, J 2019, ' Group cognitive behavioural programme to reduce the impact of rheumatoid arthritis fatigue : the RAFT RCT with economic and qualitative evaluations ', Health Technology Assessment, vol. 23, no. 57 . https://doi.org/10.3310/hta23570
Health Technology Assessment, Vol 23, Iss 57 (2019)
ISSN: 1366-5278
DOI: 10.3310/hta23570
Popis: 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 p 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 p 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 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.
Databáze: OpenAIRE
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