Title: A feasibility study to test a caregiver intervention for people with chronic pain (JOINT SUPPORT)
Funder: Department of Health and Social Care

Abstract: RESEARCH QUESTION: What is the feasibility of conducting a pragmatic, multi-centre randomised controlled trial (RCT) to test the effectiveness of an informal caregiver training programme to support people with chronic musculoskeletal pain. BACKGROUND: Chronic musculoskeletal pain is a disabling condition seen in all age groups.[1] This commonly includes low back pain, neck pain, fibromyalgia and osteoarthritis, affecting approximately 17 million people in the UK.[2] Patients frequently struggle to manage their pain and everyday activities to maintain independence and quality of life.[3] They often gain support from informal caregivers including a spouse, partner, family members or friends. Supporting people with chronic musculoskeletal pain during day-to-day tasks can have a negative impact both physically and mentally. Usual NHS care focuses on the patient. It does not include caregiver interventions to support patient s symptom management. We have developed an intervention (JOINT SUPPORT) to address this, which we will test in this study. AIMS: To assess the feasibility of conducting a pragmatic, multi-centre RCT to test the effectiveness of an informal caregiver training programme to support people with chronic musculoskeletal pain. OBJECTIVES: To evaluate: 1. Feasibility of recruitment. 2. Acceptability of the intervention. 3. Fidelity of health professionals to deliver the intervention. 4. Fidelity of caregivers to deliver the intervention at home. 5. Acceptability of randomisation. 6. Risk of intervention contamination. 7. Completeness of data collection. 8. Signal of whether the intervention works. METHODS: Setting: 4 NHS physiotherapy/occupational therapy services. Population: 80 community-dwelling patients with chronic musculoskeletal pain who have an informal caregiver. Experimental Intervention: 52 patients will be randomised to JOINT SUPPORT PLUS standard NHS care. JOINT SUPPORT comprises 5, 1-hour, group sessions, delivered by a physiotherapist or occupational therapist, to the patient and their main informal caregiver, in a group of up to 5 dyads. Sessions cover: exercise, lifestyle modification, problem-solving everyday tasks, education on pain, coping strategies for the patient and caregiver, and medication use. Dyads will be supported with 3 telephone calls and the JOINT SUPPORT Workbook, providing interactive worksheets, goal-setting plans and checklists to help caregivers support their friend/family member. Control: 28 patients will receive standard NHS care comprising patient-focused treatments including: exercise; medication prescription; advice/education. There is no routine formal support for caregivers. Frequency and composition of control interventions will be monitored. Measurement: Data collected at baseline and 3 months post-randomisation will include: screening logs, intervention logs, fidelity checklists, delegation logs and clinical outcomes including quality of life, physical, emotional, adverse event and resource use for the patient and caregiver. Qualitative Study: Interviews with 48 participants (patients and caregivers) and 12 health professionals to investigate perceptions of the study. TIMELINES: Prior to start: Protocol and approvals Month 1-3: Finalise approvals. Site set-up Month 4-14: Recruitment Month 4-20: Data collection Month 20-24: Analysis, final publications, dissemination Post-contract: Protocol preparation for a definitive trial/NIHR grant application (if indicated) ANTICIPATED IMPACT/DISSEMINATION: The results will support the design of a definitive NIHR-funded RCT. With our PPI representatives and stakeholders, we have co-developed a dissemination strategy including papers, briefing reports and media content.

Lay abstract: Bone, joint and muscle pain causes disability and reduces quality of life and independence. People with long-term bone, joint and muscle pain often use family members or friends to be caregivers, to help with washing, dressing, cooking, eating, shopping and other tasks. Unfortunately, these people are often unsure how to help. They are left to work out what to do by themselves. We suggest that showing caregivers how to help in a training programme could solve many of these problems, to improve patient and caregiver health and well-being. We want to test this programme (which we have called JOINT SUPPORT) and the project design in a small way, to see if this can be made to work. We will recruit 80 patients with long-term bone, joint and muscle pain, and their caregivers. These will be allocated at random to one of two groups (randomised controlled trial or RCT). One group of 52 patients will receive the JOINT SUPPORT programme PLUS normal NHS care. The other group of 28 patients will receive normal NHS care. The JOINT SUPPORT programme involves five, 1-hour group sessions with a patient and their main caregiver where they are provided with information and will talk about topics including: exercise, lifestyle changes, problem-solving everyday tasks, taught about pain, how to cope and painkiller use. After the group sessions, they will have three telephone calls, and be given a workbook with all the information talked about in. We will collect information on how the project worked in recruiting people, providing the JOINT SUPPORT programme and collecting data. We will also interview patients, caregivers and health professionals to get their views on how the study worked for them. The views of patients and caregivers have helped design this study. They have helped with the research question, the JOINT SUPPORT programme and study design. One of our co-applicants (Martin Smith) has long-term knee pain. He and his wife Christine, who is his caregiver, are part of our team and will help us by providing a patient and caregiver voice during the project. The findings will be shared with health professionals and patients through articles, conference presentations, social media blogs and newsletters. Free resources developed through this study will be shared through UK community networks and charities.

Research activity codes: 6.7 PHYSICAL
Health categories: MUSCULOSKELETAL