Reducing rheumatoid Arthritis Fatigue impact - clinical Teams using cognitive behavioural approaches (RAFT): randomised controlled trial with economic and qualitative evaluations

Background: Fatigue is a major problem in rheumatoid arthritis (RA). There is evidence for cognitive behavioural therapy (CBT) delivered by clinical psychologists but few rheumatology units have psychologists. Objectives: To compare clinical and cost-effectiveness of a group CBT programme for RA fatigue (RAFT) delivered by the rheumatology team in addition to usual care, versus usual care alone; to evaluate RAFT tutors’ experiences. Design: Randomised controlled trial. Central trials unit computerised randomisation in four consecutive cohorts within each of 7 centres. Nested qualitative evaluation.Setting: Seven hospital rheumatology units in England/WalesParticipants: Adults with RA and fatigue severity u003e6/10; no recent changes in major RA medication/glucocorticoids.Interventions: RAFT: group CBT course delivered by rheumatology tutor pairs (nurses/occupational therapists). Usual care; brief discussion of an RA fatigue self-management booklet with the research nurse.Main outcome measures: Primary: Fatigue impact (Bristol RA Fatigue Numerical Rating Scale) at 26 weeks. Secondary: Fatigue severity/coping (BRAF-NRS), broader fatigue impact (BRAF Multi-Dimensional Questionnaire), self-reported clinical status, quality of life, mood, self-efficacy, satisfaction (26, 52, 78, 104 weeks). Intention-to-treat analysis conducted blind to allocation, adjusted for baseline scores and centre. Cost-effectiveness explored through intervention and RA-related health/social care costs, calculating quality-adjusted life-years (QALYs) with EQ-5D-5L. Tutor interviews/focus group analysed with inductive thematic analysis.Results: 308/333 patients completed 26 weeks (156/175 RAFT, 152/158 controls). At 26 weeks mean BRAF-NRS Impact was reduced for RAFT (-1.36, p 8/10 (controls rating booklet 54%, pu003c0.0001); and 96%/68% recommending RAFT/booklet to others (pu003c0.001). There was no significant difference between arms for total societal costs including RAFT training/delivery (£434, CI £-389, +£1258) nor QALYs gained (0.008, CI -0.008, +0.023). The probability of RAFT being cost-effective was 28-35% at NICE thresholds of £20-30,000/QALY. Tutors felt RAFT’s CB approaches challenged their usual problem-solving habits but helped patients make life changes, and improved tutors’ wider clinical practice.Limitations: Primary outcome data missing for 25 patients; EQ-5D-5L might not capture fatigue change; 30% of 2-year economic data missing. Conclusions: RAFT improves RA fatigue impact beyond usual care alone, sustained for two years with high patient satisfaction, enhanced team skills and no harms. RAFT is u003c50% likely to be cost-effective but NHS costs were similar between arms.Future work: Given the paucity of RA fatigue interventions, rheumatology teams might investigate pragmatic implementation of RAFT, which is low-cost.