School of Healthcare, University of Leeds, Leeds, UK
Leeds Institute of Rheumatic and Musculoskeletal Medicine and NIHR Leeds Biomedical Research Centre, University of Leeds, Leeds, UK.
BMJ Open. 2021 Jul 21;11(7):e045389. doi: 10.1136/bmjopen-2020-045389.
To determine the feasibility of conducting a randomised controlled trial (RCT) of a peer mentorship intervention to improve self-management of osteoarthritis (OA).
Six-month parallel group non-blinded randomised feasibility trial.
One secondary care and one primary care UK National Health Service Trust.
Fifty adults aged ≥55 years old with hip and/or knee OA.
Participants were allocated 1:1 to the intervention or control group using an online randomisation service. Intervention group participants received usual care (information resources) and up to eight community-based self-management support sessions delivered by a peer mentor (trained volunteer with hip and/or knee OA). Control group participants received usual care only.
Key feasibility outcomes were participant and peer mentor recruitment and attrition, intervention completion and the sample size required for a definitive RCT. Based on these feasibility outcomes, four success criteria for proceeding to a definitive RCT were prespecified. Patient-reported outcomes were collected via questionnaires at baseline, 8 weeks and 6 months.
Ninety-six individuals were screened, 65 were eligible and 50 were randomised (25 per group). Of the 24 participants who commenced the intervention, 20 completed it. Four participants did not complete the 6-month questionnaire. Twenty-one individuals were eligible for the peer mentor role, 15 were trained and 5 withdrew prior to being matched with a participant. No intervention-related harms occurred. Allowing for 20% attrition, the sample size required for a definitive RCT was calculated as 170 participants. The intervention group showed improvements in self-management compared with the control group.
The feasibility outcomes achieved the prespecified criteria for proceeding to an RCT. The exploratory analyses suggest peer mentorship may improve OA self-management. An RCT of the OA peer mentorship intervention is therefore warranted with minor modifications to the intervention and trial procedures.
ISRCTN:50675542.
确定开展一项同伴指导干预以改善骨关节炎（OA）自我管理的随机对照试验（RCT）的可行性。
6 个月平行组非盲随机可行性试验。
一家二级保健和一家初级保健英国国民保健服务信托。
50 名年龄≥55 岁的髋和/或膝关节 OA 成人。
参与者使用在线随机服务以 1:1 的比例分配到干预组或对照组。干预组参与者接受常规护理（信息资源）和最多 8 次由同伴导师（经过培训的患有髋和/或膝关节 OA 的志愿者）提供的社区自我管理支持课程。对照组参与者仅接受常规护理。
主要可行性结果是参与者和同伴导师的招募和流失、干预完成情况以及进行确定性 RCT 所需的样本量。基于这些可行性结果，预先指定了进行确定性 RCT 的四个成功标准。通过问卷在基线、8 周和 6 个月时收集患者报告的结果。
对 96 名个体进行了筛选，其中 65 名符合条件，50 名被随机分配（每组 25 名）。在开始接受干预的 24 名参与者中，有 20 名完成了干预。有 4 名参与者未完成 6 个月的问卷。有 21 名个体符合同伴导师角色的资格，其中 15 人接受了培训，5 人在与参与者匹配之前退出。未发生与干预相关的伤害。考虑到 20%的流失率，进行确定性 RCT 所需的样本量计算为 170 名参与者。与对照组相比，干预组的自我管理得到了改善。
可行性结果达到了进行 RCT 的预定标准。探索性分析表明，同伴指导可能改善 OA 的自我管理。因此，有必要对 OA 同伴指导干预进行 RCT，仅对干预和试验程序进行微小修改。
ISRCTN:50675542。
