{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,29]],"date-time":"2026-06-29T16:19:27Z","timestamp":1782749967783,"version":"3.54.5"},"reference-count":127,"publisher":"National Institute for Health and Care Research","issue":"57","license":[{"start":{"date-parts":[[2019,10,1]],"date-time":"2019-10-01T00:00:00Z","timestamp":1569888000000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/www.nationalarchives.gov.uk\/doc\/non-commercial-government-licence\/non-commercial-government-licence.htm"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["11\/112\/01"],"award-info":[{"award-number":["11\/112\/01"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"\n Background<\/jats:title>\n Fatigue is a major problem in rheumatoid arthritis (RA). There is evidence for the clinical effectiveness of cognitive\u2013behavioural therapy (CBT) delivered by clinical psychologists, but few rheumatology units have psychologists.<\/jats:p>\n <\/jats:sec>\n \n Objectives<\/jats:title>\n 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\u2013behavioural (CB) approaches], delivered by the rheumatology team in addition to usual care (intervention), with usual care alone (control); and to evaluate tutors\u2019 experiences of the RAFT programme.<\/jats:p>\n <\/jats:sec>\n \n Design<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Setting<\/jats:title>\n Seven hospital rheumatology units in England and Wales.<\/jats:p>\n <\/jats:sec>\n \n Participants<\/jats:title>\n Adults with RA and fatigue severity of \u2265\u20096 [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.<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n RAFT \u2013 group CBT programme delivered by rheumatology tutor pairs (nurses\/occupational therapists). Usual care \u2013 brief discussion of a RA fatigue self-management booklet with the research nurse.<\/jats:p>\n <\/jats:sec>\n \n Main outcome measures<\/jats:title>\n Primary \u2013 fatigue impact (as measured by the BRAF-NRS) at 26 weeks. Secondary \u2013 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.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n A total of 308 out of 333 patients completed 26 weeks (RAFT, n\/N<\/jats:italic>\u2009=\u2009156\/175; control, n\/N<\/jats:italic>\u2009=\u2009152\/158). At 26 weeks, the mean BRAF-NRS impact was reduced for the RAFT programme (\u20131.36 units; p<\/jats:italic>\u2009<\u20090.001) and the control interventions (\u20130.88 units; p<\/jats:italic>\u2009<\u20090.004). Regression analysis showed a difference between treatment arms in favour of the RAFT programme [adjusted mean difference \u20130.59 units, 95% confidence interval (CI) \u20131.11 to \u20130.06 units; p<\/jats:italic>\u2009=\u20090.03, effect size 0.36], and this was sustained over 2 years (\u20130.49 units, 95% CI \u20130.83 to \u20130.14 units; p<\/jats:italic>\u2009=\u20090.01). At 26 weeks, further fatigue differences favoured the RAFT programme (BRAF-MDQ fatigue impact: adjusted mean difference \u20133.42 units, 95% CI \u20136.44 to \u2013 0.39 units, p<\/jats:italic>\u2009=\u20090.03; living with fatigue: adjusted mean difference \u20131.19 units, 95% CI \u20132.17 to \u20130.21 units, p<\/jats:italic>\u2009=\u20090.02; and emotional fatigue: adjusted mean difference \u20130.91 units, 95% CI \u20131.58 to \u20130.23 units, p<\/jats:italic>\u2009=\u20090.01), 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<\/jats:italic>\u2009=\u20090.02), as did BRAF-NRS coping over 2 years (adjusted mean difference 0.42 units, 95% CI 0.08 to 0.77 units; p<\/jats:italic>\u2009=\u20090.02). 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 \u2265\u20098 out of 10, compared with 54% of patients in the control arm rating the booklet (p<\/jats:italic>\u2009<\u20090.0001); and 96% of patients and 68% of patients recommending the RAFT programme and the booklet, respectively, to others (p<\/jats:italic>\u2009<\u20090.001). There was no significant difference between arms for total societal costs including the RAFT programme training and delivery (mean difference \u00a3434, 95% CI \u2013\u00a3389 to \u00a31258), nor QALYs gained (mean difference 0.008, 95% CI \u20130.008 to 0.023). The probability of the RAFT programme being cost-effective was 28\u201335% at the National Institute for Health and Care Excellence\u2019s thresholds of \u00a320,000\u201330,000 per QALY. Tutors felt that the RAFT programme\u2019s CB approaches challenged their usual problem-solving style, helped patients make life changes and improved tutors\u2019 wider clinical practice.<\/jats:p>\n <\/jats:sec>\n \n Limitations<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n 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 <\u200950% likely to be cost-effective; however, NHS costs were similar between treatment arms.<\/jats:p>\n <\/jats:sec>\n \n Future work<\/jats:title>\n Given the paucity of RA fatigue interventions, rheumatology teams might investigate the pragmatic implementation of the RAFT programme, which is low cost.<\/jats:p>\n <\/jats:sec>\n \n Trial registration<\/jats:title>\n Current Controlled Trials ISRCTN52709998.<\/jats:p>\n <\/jats:sec>\n \n Funding<\/jats:title>\n This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment<\/jats:italic>; Vol. 23, No. 57. See the NIHR Journals Library website for further project information.<\/jats:p>\n <\/jats:sec>","DOI":"10.3310\/hta23570","type":"journal-article","created":{"date-parts":[[2019,10,11]],"date-time":"2019-10-11T08:01:18Z","timestamp":1570780878000},"page":"1-130","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":19,"title":["Group cognitive\u2013behavioural programme to reduce the impact of rheumatoid arthritis fatigue: the RAFT RCT with economic and qualitative evaluations"],"prefix":"10.3310","volume":"23","clinical-trial-number":[{"clinical-trial-number":"isrctn52709998","registry":"10.18810\/isrctn","type":"results"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7851-2039","authenticated-orcid":true,"given":"Sarah","family":"Hewlett","sequence":"first","affiliation":[{"name":"Department of Nursing and Midwifery, University of the West of England Bristol, Bristol, 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