• Sarah Hewlett, Celia Almeida, Nicholas Ambler, Peter S Blair, Ernest Choy, Emma Dures, Alison Hammond, William Hollingworth, Bryar Kadir, John Kirwan, Zoe Plummer, Clive Rooke, Joanna Thorn, Nicholas Turner, and Jonathan Pollock.
• Department of Nursing and Midwifery, University of the West of England Bristol, Bristol, UK.
• Health Technol Assess. 2019 Oct 1; 23 (57): 1-130.

BackgroundFatigue 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.ObjectivesTo 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.DesignA randomised controlled trial. Central trials unit computerised randomisation in four consecutive cohorts within each of the seven centres. A nested qualitative evaluation was undertaken.SettingSeven hospital rheumatology units in England and Wales.ParticipantsAdults 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.InterventionsRAFT - 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 MeasuresPrimary - 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.ResultsA 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.LimitationsPrimary 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.ConclusionsThe 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 WorkGiven the paucity of RA fatigue interventions, rheumatology teams might investigate the pragmatic implementation of the RAFT programme, which is low cost.Trial RegistrationCurrent Controlled Trials ISRCTN52709998.FundingThis 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.

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