手部骨关节炎电子自我管理干预措施（“快乐手部”应用程序）的评估：一项多中心随机对照试验的研究方案。
Evaluation of an e-self-management intervention (Happy Hands app) for hand osteoarthritis: Study protocol for a multicentre randomised controlled trial.
作者信息
Tveter Anne Therese, Fjeldstad Kristine Aasness, Varsi Cecilie, Maarnes Marit Kristin, Pedersen Stein Jarle, Christensen Barbara S, Blanck Thalita, Nyheim Sissel B, Prior Yeliz, Björk Mathilda, Pelle Tim, Kjeken Ingvild
机构信息
Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Health Service Research and Innovation Unit, Oslo, Norway.
Faculty of Health and Social Sciences, University of South-Eastern Norway, Drammen, Norway.
出版信息
Rheumatol Int. 2025 Jan 16;45(1):30. doi: 10.1007/s00296-025-05787-6.
OBJECTIVE
This protocol paper describes the rationale and design of a randomised controlled trial (RCT) that aims to evaluate the (cost-)effectiveness of a 12 week e-self-management intervention (Happy Hands app) in people with hand osteoarthritis (HOA).
METHODS
In this multicentre RCT, 376 people with HOA will be recruited from all four health regions in Norway. Consenting participants will be randomly allocated to either a control group receiving usual care or an intervention group receiving the Happy Hands app in addition to usual care. Primary outcome will be measured at 3-months follow-up as the proportion of participants classified as OMERACT-OARSI responders (a composite score comprising change in pain, function, and disease activity), analysed using logistic regression. Secondary outcomes, including pain, hand function, stiffness, quality-of-care, health-related quality-of-life, grip strength, adherence and healthcare costs will be measured at 3- and 6-months follow-up.
RESULTS
Recruitment was initiated in November 2022 with a total of 386 participants recruited by August 2023, 194 in the intervention group and 192 in the control group. Data collection was completed in February 2024.
DISCUSSION
To our knowledge, this is one of the first large-scale, multicentre RCTs assessing the (cost-)effectiveness of a self-management program delivered through a smartphone app for people with HOA. The results from this trial can enhance our understanding of the role technology can play in managing HOA.
TRIAL REGISTRATION
NCT05568875 ( https://clinicaltrials.gov/study/NCT05568875 , pre-registered October 3, 2022).
目的
本方案文件描述了一项随机对照试验（RCT）的基本原理和设计，该试验旨在评估一项为期12周的电子自我管理干预措施（“快乐之手”应用程序）对手部骨关节炎（HOA）患者的（成本）效益。
方法
在这项多中心RCT中, 将从挪威所有四个健康地区招募376名HOA患者。同意参与的参与者将被随机分配到接受常规护理的对照组或除常规护理外还接受“快乐之手”应用程序的干预组。主要结局将在3个月随访时测量，作为被分类为OMERACT - OARSI反应者的参与者比例（一个由疼痛、功能和疾病活动变化组成的综合评分），使用逻辑回归进行分析。次要结局，包括疼痛、手部功能、僵硬程度、护理质量、健康相关生活质量、握力、依从性和医疗费用，将在3个月和6个月随访时测量。
结果
招募工作于2022年11月开始，截至2023年8月共招募了386名参与者，其中干预组194名，对照组192名。数据收集于2024年2月完成。
讨论
据我们所知，这是首批大规模、多中心RCT之一，评估通过智能手机应用程序为HOA患者提供的自我管理计划的（成本）效益。该试验结果可以增进我们对技术在管理HOA中所起作用的理解。
试验注册
NCT05568875（https://clinicaltrials.gov/study/NCT05568875，2022年10月3日预注册）。
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