在类风湿性关节炎中移动健康自我管理干预的有效性和可行性:实用多中心随机对照试验 (AEGORA) 的研究协议
Michaël Doumen1,2, Elias De Meyst3,4, Cedric Lefevre4
1Department of Development and Regeneration, Skeletal Biology and Engineering Research Centre, KU Leuven, Leuven, Belgium. michael.doumen@kuleuven.be.
Trials
|October 29, 2023
概括
这项研究评估了一个移动健康应用程序干预措施,以提高类风湿关节炎的自我有效性和监测疾病影响. 它探讨了使用mHealth工具的患者的应用程序参与和潜在的症状超警.
科学领域:
- 类风湿病学 类风湿病学
- 数字健康数字健康
- 患者自我管理
背景情况:
- 类风湿性关节炎 (RA) 显著影响患者的生活质量.
- 自主管理干预措施,包括移动健康 (mHealth) 应用程序,可以提高患者的自我效能.
- 移动健康应用程序提供患者报告结果的远程监测,但对用户参与和症状超警的担忧.
研究的目的:
- 调查基于mHealth的自我管理干预措施 (AEGORA) 的有效性,以提高RA患者的自我有效性.
- 远程监测疾病影响,使用类风湿关节炎疾病影响 (RAID) 问卷.
- 评估参与者的参与和远程症状监测的潜在负面影响.
主要方法:
- 一个多中心,务实的随机受控试验 (AEGORA) 涉及120名RA患者.
- 干预组获得了一个mHealth应用程序 (Sidekick),提供教育,目标设定和生活方式建议.
- 随机化 (2:1:1) 给常规护理或干预组,对RAID问卷的提示频率有所不同;在基线和4-6个月评估结果.
主要成果:
- 主要终点是干预组与常规护理相比,关节炎自效量表的临床重要改善.
- 二级终点包括疼痛灾难性的非劣势,RAID的优势,睡眠质量和体力活动.
- 探索应用程序参与度,提示频率和研究结果之间的关系.
结论:
- 该AEGORA试验将确定RA的多组分mHealth自我管理干预措施的有效性.
- 它将提供有关疾病活动动态的见解以及远程症状监测的可行性.
- 该研究还将评估与RA的mHealth干预相关的潜在不良影响,例如症状过度警.
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