Warwick Medical School, University of Warwick, Coventry, UK
Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, Norfolk, UK.
BMJ Open. 2023 Jan 27;13(1):e070865. doi: 10.1136/bmjopen-2022-070865.
Chronic musculoskeletal (bone, joint or muscle) pain is disabling. People with it frequently have difficulties in managing everyday activities. Individuals may rely on family members or friends to support them. These people are known as informal caregivers. No interventions have previously addressed the health needs of people with chronic musculoskeletal pain and their caregivers. In response, the JOINT SUPPORT programme was developed. In this study, we will assess the feasibility and acceptability of conducting a pragmatic, multicentre, randomised controlled trial (RCT) to test the clinical and cost-effectiveness of the JOINT SUPPORT programme to support these individuals.
This will be a mixed-methods feasibility RCT. We will recruit 80 patients with chronic musculoskeletal pain with their informal caregivers. Patients will be randomised to usual National Health Service (NHS) care usual NHS care plus a caregiver-patient dyad training programme (JOINT SUPPORT). This programme comprises of five, 1-hour, group-based sessions for patients and caregivers, delivered by trained physiotherapists or occupational therapists. It includes developing skills in: understanding pain, pacing, graded activity, fear avoidance and goal-setting, understanding benefits of physical activity and skills in medication management. This will be re-enforced with a workbook. After the group-based sessions, patients and caregivers will be supported through three telephone sessions with a therapist. Data collected at baseline and 3 months will include: screening logs, intervention logs, fidelity checklists and clinical outcomes on quality of life, physical and emotional outcomes, adverse events and resource use. Qualitative research with 24 patient-caregiver dyads and 12 healthcare professionals will explore the acceptability of trial processes. Stop-go criteria will inform the progression to a full trial.
Ethical approval was obtained on 22 February 2022 (National Research Ethics Committee Number: 22/NW/0015). Results will be reported at conferences, peer-review publications and across social media channels.
ISRCTN78169443.
慢性肌肉骨骼(骨骼、关节或肌肉)疼痛会使人丧失能力。患有这种疾病的人经常在日常生活活动中遇到困难。他们可能依赖家庭成员或朋友来支持他们。这些人被称为非正式照顾者。以前没有干预措施来满足患有慢性肌肉骨骼疼痛的患者及其照顾者的健康需求。为此,开发了 JOINT SUPPORT 计划。在这项研究中,我们将评估开展实用、多中心、随机对照试验(RCT)的可行性和可接受性,以测试支持这些患者及其照顾者的 JOINT SUPPORT 计划的临床和成本效益。
这将是一项混合方法可行性 RCT。我们将招募 80 名患有慢性肌肉骨骼疼痛的患者及其非正式照顾者。患者将被随机分配到常规的国民保健服务(NHS)护理常规 NHS 护理加患者-照顾者二元培训计划(JOINT SUPPORT)。该计划包括为患者和照顾者提供五个 1 小时的小组课程,由经过培训的物理治疗师或职业治疗师进行,内容包括:了解疼痛、调整活动、分级活动、避免恐惧和设定目标、了解身体活动的益处以及药物管理技能。这将通过工作手册得到加强。在小组课程结束后,患者和照顾者将通过与治疗师的三次电话会话得到支持。在基线和 3 个月时收集的数据包括:筛查日志、干预日志、保真度检查表以及生活质量、身体和情绪结果、不良事件和资源使用的临床结果。对 24 对患者-照顾者和 12 名医疗保健专业人员进行的定性研究将探讨试验过程的可接受性。停止-继续标准将为全面试验的进展提供信息。
2022 年 2 月 22 日获得了伦理批准(国家研究伦理委员会编号:22/NW/0015)。结果将在会议、同行评审出版物和社交媒体渠道上报告。
ISRCTN78169443。