Title: Fatigue - Reducing its Effects through individualised support Episodes in Inflammatory Arthritis (FREE-IA): A Feasibility Study for a Randomised Controlled Trial
Funder: Department of Health and Social Care

Abstract: Background Inflammatory arthritis refers to a group of auto-immune rheumatic conditions, most commonly rheumatoid arthritis (RA). In the UK, approximately 690,000 adults have RA. Around three quarters of people diagnosed are of working age, and there are 20,000 new cases every year. Fatigue is a distressing symptom, present on most days for most patients with inflammatory arthritis, with >70% reporting levels similar to Chronic Fatigue Syndrome. However, rheumatology nurses and occupational therapists (OTs) working with this patient group have reported that they do not know how to provide appropriate support. Our team has developed an intervention called FREE-IA (Fatigue - Reducing its Effects through individualised support Episodes in Inflammatory Arthritis) to reduce the impact of fatigue. FREE-IA is a brief, pragmatic intervention, delivered by rheumatology nurses/OTs using cognitive techniques. FREE-IA comprises two core sessions plus up to two optional sessions. Aims Our long-term aim is to test the clinical and cost-effectiveness of FREE-IA. However, we first need to answer the question of whether it is feasible to conduct a definitive randomised controlled trial (RCT) of FREE-IA. To address this question, our feasibility study has two main aims: To design and deliver the FREE-IA training package to rheumatology nurses/OTs; To explore and resolve key uncertainties to allow the final development of a definitive RCT of FREE-IA. Plan of investigation The feasibility study will be conducted in four phases: In Phase 1, we will develop and deliver FREE-IA training to approximately 6-8 rheumatology nurses/OTs from four sites. Training will be delivered face-to-face in a central location over two days. We will also prepare study documentation and gain ethics and other necessary approvals for the feasibility study. In Phase 2, we will recruit 50-60 patients from across the four sites, and collect their baseline data. Rheumatology nurses/OTs who have received the training will then deliver FREE-IA to participants at the end of their routine consultations. The two core sessions will be delivered face-to-face. The additional, optional, two sessions can be delivered face-to-face, by telephone, or by Skype, depending on participant preference. In Phase 3, we will collect quantitative outcome data at two time points to determine follow-up rates and completion rates of outcome measures from participants who have received the intervention. Our proposed clinical outcome measures include fatigue impact (the planned primary outcome), fatigue severity and importance, impact of disease, and disability. Our proposed measures of therapeutic mechanisms include participants self-efficacy, health competency, and support for autonomy. We will also collect data to inform the design of a health economics evaluation alongside a future definitive RCT. In Phase 3, we will also conduct a qualitative evaluation to determine the acceptability of FREE-IA to participants, and to gain insight into the experiences of nurses/OTs who have delivered the intervention. Data will be generated in one-to-one semi-structured interviews. In Phase 4, we will refine the intervention and prepare a grant preparation for a definitive RCT, if supported by evidence from Phase 3. The decision will be informed by recruitment rates, uptake and delivery of the intervention, completion rates of outcome measures, and acceptability of FREE-IA to participants. Potential benefits to patients and the NHS Short-term, this study will inform us whether we can design a definitive RCT to test the clinical and cost-effectiveness of FREE-IA. If, following the definitive trial, we find that FREE-IA is effective, it has the potential to benefit patients by offering flexible, accessible support for a symptom that causes high levels of distress. There is the potential to benefit the NHS by providing rheumatology nurses/OTs with additional skills-training to enhance the self-management support that they can offer patients.

Lay abstract: Inflammatory arthritis describes a group of long-term conditions that affect the immune system. Around one in 12 women and one in 20 men will develop inflammatory arthritis during their lifetime. Symptoms include pain, stiffness, joint damage and fatigue. In inflammatory arthritis, fatigue is the main reason for work disability and is associated with high healthcare costs. Patients describe fatigue as disabling, distressing and overwhelming. They consistently report that they need help to deal with it. Rheumatology nurses and occupational therapists (OTs) who provide patient care recognise that fatigue is a problem, but do not know how to help. Previously, we developed a self-management programme that can reduce the effects of fatigue. However, it is lengthy and requires patients to attend six group sessions of two hours each and nurses/OTs to run a separate service. In our experience, almost 40% of patients find it a challenge to attend such a lengthy programme. Therefore we have developed FREE-IA (Fatigue - Reducing its Effects through individualised support Episodes in Inflammatory Arthritis). FREE-IA comprises 2-4 sessions of 20-30 minutes, and can be used in routine consultations. It is designed to help patients identify influences on their fatigue and to manage their activity accordingly. FREE-IA is less demanding in the number and length of sessions, is individualised, and has the potential to be accessible to large numbers of patients. We need to know: Can we train nurses/OTs to use FREE-IA in routine consultations? Is FREE-IA acceptable to patients? Can we collect research data from patients about their fatigue? If this is possible, we will apply for funding to test whether FREE-IA reduces the effects of patients fatigue and healthcare costs, compared to usual support. FREE-IA has the potential to benefit patients by offering accessible support for a symptom that causes high levels of distress.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: INFLAMMATORY AND IMMUNE SYSTEM