Title: Reducing Arthritis Fatigue - clinical Teams using cognitive-behavioural approaches (RAFT)
Funder: Department of Health and Social Care

Abstract: 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. Inductive thematic analysis will be used to identify and code ideas, explore links and build themes, then findings explored in a focus group of the other 3 tutor pairs. Sample size: Our original RCT showed an adjusted statistically significant difference in fatigue impact of 1.95 units on a VAS of 0-10 (SD 2.7, effect size 0.77), from CBT delivered by a clinical psychologist. We have assumed clinical teams using CB approaches can achieve 75% of this, indicative of a modest but clinically significant effect. Including design effects from group and centre/therapist clustering, an analytical sample size of 75/arm would achieve 90% power (p<0.05, two-sided). We have capacity to recruit up to 300 patients to allow for attrition at the required 2 year follow-up period, and other contingencies. Recruitment: A pragmatic approach takes account of natural variation in group size, the need for viable groups, and number of centres for timely completion. Seven centres running 4 courses allows for variation in group size (5-7 per group gives 140-196 CB participants) or for some centres to run fewer courses (eg in staff absence). Recruitment will stop as close to 150 patients/arm as is consistent with viable group formation. Translation into care: Any minor adjustments to RAFT and feasibility of wide delivery will be informed by the RCT experiences. A trainer’s guide will be developed for local CB Therapists to train and supervise in clinical practice (aligned to QISMET standards for self-management programmes). RAFT will be copyrighted with free licensed use across the NHS. Findings will be submitted to NICE for inclusion in RA guidelines. Clinical Commissioning Groups will be informed, and all UK rheumatology teams invited to RAFT taster sessions at interactive RoadShows. Project management: Weekly business meetings; monthly Trial Management Group meetings; annual Trial Steering Committee meetings with Data Management Committee responsibilities. Plan: -6-0 months: Ethics, R&D, staff recruited. 0-8m: Site visits, recruitment starts, training and practice courses. 8-27m: 4 courses/centre. 27-36m: primary outcome paper; qualitative study and paper. 36-48m data returns; 48-54m: long-term effects paper; submission to NICE and Clinical Commissioning Groups; mailshot NHS teams, taster RoadShows; website; conference symposia 1) Hewlett et al. Ann Rheum Dis 2011;70:1060-7. 2) Dures et al. Rheumatology 2012;51(S3):167–8. 3) Nicklin et al. Arth Care Res 2010;62:1559-68

Lay abstract: Rheumatoid Arthritis (or RA) is a lifelong inflammatory condition affecting most joints, with fluctuating pain and swelling leading to joint damage and disability. Medication aims to control inflammation, and hospital rheumatology teams support the patient in self-managing their symptoms. About half a million people in the UK have RA and up to 70% have fatigue on most days. They struggle to manage fatigue, which is much worse than normal tiredness, and as bad as their RA pain. Fatigue may be physical (feeling wiped out), cognitive (unable to concentrate) or emotional (frustration), and may affect ability to stay in paid work. Fatigue is rarely asked about in clinic, and support is not routinely offered – patients generally pick up a leaflet. The commissioning brief asks us to test whether a simplified psychological intervention that could be delivered widely in the NHS, reduces RA fatigue and is an efficient use of NHS resources. The intervention we will test is a cognitive-behavioural course, delivered by the usual rheumatology clinical team: Reducing Arthritis Fatigue – clinical Teams using cognitive behavioural approaches (RAFT). RA fatigue seems to be caused by varying combinations of inflammation, pain, disability, depression, stress, poor sleep, or behaviours such as working excessively. This means that helping people adopt self-management strategies should be useful. There are links between people’s thoughts, feelings, behaviours and symptoms. For example if someone thinks that housework must be done perfectly and feels guilty if it is not, they may overwork without a break, leading to exhaustion. In Cognitive Behavioural Therapy, trained CBT practitioners use reflective questioning to help patients work out these links themselves, and then gently challenge patients to re-think their beliefs and feelings, and so make changes in their behaviours. We previously tested a CBT course for RA fatigue in a formal research trial. Courses were led by a psychologist and substantially improved fatigue impact, severity and coping, and mood, sleep and disability. However, few rheumatology teams have psychologists, therefore we wish to test whether rheumatology nurses or occupational therapists (OTs) could lead the course if we teach them these CB skills and give them a detailed, written manual of the course. With the help of two patient partners and two clinical staff, we developed a manual of the original course, with detailed guides for the 7 sessions, and all the patient handouts (eg daily activity charts). We devised a 4-day staff training on CB approaches such as reflective questioning, goal-setting, problem-solving and group management, and how to use the course manual. To complete training, the rheumatology nurse and OT (tutor pair) must run a practice course observed by a psychologist. In our pilot study, the local tutors then ran a course as they would in practice, which patients rated as 8.8/10 for satisfaction. Their feedback helped refine the training and manual. This simplified CB intervention (RAFT) is now ready to be formally tested. To see whether the intervention is widely deliverable in the NHS, CB courses will be delivered jointly by two local rheumatology staff in each of 7 hospitals, to groups of 5-7 patients. A course comprises 2 hours a week for 6 weeks, then a consolidation session 8 weeks later. Patients who agree to join the trial will be assigned randomly (by chance) to either RAFT or for comparison, to their usual care. Patients in both groups will received the Arthritis Research UK fatigue self-management booklet, which is the most recent information available, revised by this team in 2011. We have calculated from our earlier study, that to show any clinically important effects from RAFT are unlikely to have happened by chance, we need to randomise 300 patients. This allows for some patients to drop out, or if some centres cannot run all 4 courses (eg due to staff sickness). The main outcome is change in fatigue impact at 6 months. We will also measure fatigue severity and coping, pain, disability, mood, sleep, quality of life, and return to valued activities (eg hobbies). To evaluate the cost of this intervention to the NHS we will ask patients to record their use of health services in daily diaries, and staff to record time spent on RAFT. To find out how long any effects will last, we will follow patients for 2 years, which may provide helpful information on whether (and when) a booster session is needed. In the last trial we interviewed patients to understand their experience of receiving CBT. This time we will interview staff to understand how easy or hard it was to learn CB approaches and whether the new skills have influenced how they work with patients in their wider clinical practice (and if so, how). In clinical practice a local CBT-trained professional will train and supervise the local rheumatology tutors therefore we will develop a trainer’s guide. RAFT will be copyrighted, with free licensed use across the NHS. We will submit our findings to the National Institute for Health and Clinical Excellence (NICE). NICE review evidence and have published guidelines for managing RA; if it is successful, we hope they will add RAFT to this. The Clinical Commissioning Groups who are responsible for local care provision are required to consider NICE recommendations. To enthuse staff, all UK rheumatology teams will be invited to RAFT taster sessions at interactive RoadShows. Patients will be informed about RAFT through posters in rheumatology clinics and newsletters from the National Rheumatoid Arthritis Society. The team is well-placed to conduct this research. We already work together on other RA fatigue projects, including the original CBT trial, developing questionnaires that capture the different elements of fatigue, a conceptual model of fatigue mechanisms, and systematic reviews of the evidence of what works. It is through our work that fatigue is now required to be measured in all RA clinical trials internationally. We have skills in CBT, rheumatology nursing, OT, arthritis self-management research, statistics, research design, health economics and qualitative research. Our two patient research partners participated in the original CBT trial and contributed to developing the RAFT and its materials. As co-applicants they will bring expert advice on recruitment, retention, questionnaires, and help deliver interactive tutor training.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL;8.2 HEALTH AND WELFARE ECONOMICS
Health categories: MUSCULOSKELETAL