A group of rheumatology nurses and occupational therapists will train to deliver a six-week cognitive-behavioural course to help rheumatoid arthritis patients manage crippling fatigue. Fatigue is one of the most disabling symptoms of rheumatoid arthritis, yet it is rarely addressed directly in routine care. Patients are typically given a leaflet, but no structured support. This trial tests whether a team of existing clinic staff—not specialist therapists—can be trained to run group sessions that teach patients practical skills: pacing activities, prioritising tasks, improving sleep, and managing stress. The goal is to give patients tools they can use every day to reduce fatigue’s impact on work, family life, and social activities. If the approach works, it could be rolled out across the NHS at low cost, using staff already in post. That would transform how fatigue is managed in rheumatology clinics, shifting from a problem patients are left to cope with alone to one that is actively treated. The trial also tracks costs and quality of life over two years, so funders will know whether the programme delivers value for money.
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Design: Seven-centre RCT of a group cognitive-behavioural (CB) intervention for fatigue self-management in Rheumatoid Arthritis (RA) delivered by the rheumatology team, compared to usual care (Arthritis Research UK fatigue booklet). Setting: Outpatient care; using rheumatology nurses and occupational therapists (OTs) who already support RA self-management, and understand pain, disability and fatigue interactions Population: RA patients with fatigue 6/10 or more, that they consider recurrent or persistent. Exclusion: major RA medication change within 16 wks (glucocorticoids 6 wks). Health technology: CB fatigue self-management intervention, co-facilitated by nurse and OT after brief training. CB interventions use reflective questioning to help patients link thoughts, feelings, symptoms and behaviours, to facilitate behaviour change. Groups of patients attend 6 sessions (2hrs/wk x 6 wks) and a consolidation session (wk 14). Weekly topics build on each other: energy management, pacing, priorities, sleep, stress, and assertiveness. Patients set weekly goals, with self-monitoring of activity, rest and fatigue using daily charts. In the applicants’ original RCT, this was delivered by a CB Therapist and OT (Ambler, Knops) (reference 1). We have created a manual of this programme (RAFT, Reducing Arthritis Fatigue using clinical Teams) for non-CB rheumatology professionals, plus brief training on CB approaches and RAFT delivery followed by observation of their practice course. In our pilot, a rheumatology nurse and OT (tutor pair) then ran a clinical RAFT course, after which RAFT was refined (2). In the proposed RCT, 7 tutor pairs will train together (Ambler, Knops) and run an observed practice course to complete training. Each centre will then run 4 courses for the RCT, with minimal clinical supervision (Ambler). Course quality, homogeneity and fidelity arise from standardised training, programme and materials; a random session in each course is monitored. Control: Fatigue is not routinely addressed, patients pick up leaflets in clinic. Thus the control is usual care including the Arthritis Research UK fatigue self-management booklet (revised by the team after the original RCT). Both arms receive the booklet. Outcomes: Weeks 0, 6, 10, 18, 26, 52, 78 and 104. Primary outcome is fatigue impact at 26 weeks (Bristol RA Fatigue Impact NRS) (3) with persistence evaluated over 2 years. Secondary outcomes are fatigue coping, severity and sub-dimensions, pain, disability, sleep, quality of life, mood, valued life activities, RA core set and acceptability, plus helplessness and self-efficacy (process measures). Exploratory predictors are demographics, co-morbidities and disease activity. Primary outcome is collected by phone to enhance returns. Intention-to-treat analysis of covariance (adjusted for baseline values) will use multivariable linear regression models and standardised effect sizes. Sensitivity analyses will include adjustment for any variables imbalanced at baseline, multi-level mixed effects models to test group and centre effects, and multiple imputation techniques to investigate impact of missing data. Repeated measures mixed effects ANCOVA models to examine long term outcome. Cost effectiveness: Utilities and work disability measured (EQ-5D-5L, Work Productivity and Activity Impairment), NHS costs captured in staff logs (training, delivery, supervision, group size) and patient costs in diaries (appointments, sick leave, transport). Unit costs will be derived from national estimates or local micro-costing, and cost-effectiveness calculated using fatigue impact and EQ-5D-5L for cost/QALY. Bootstrapped confidence intervals will be used with the Incremental Cost-Effectiveness Ratio and net monetary benefit statistic for NHS and societal perspectives, plus sensitivity analyses. Evaluation by tutors: To understand the process and effects of CB training, a focus group with 4 tutor pairs will be held after the final CB course
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