用于预防慢性疼痛患者成功进行多学科治疗后复发的移动健康应用程序（AGRIPPA）：一项随机对照试验的方案
Mobile Health App (AGRIPPA) to Prevent Relapse After Successful Interdisciplinary Treatment for Patients With Chronic Pain: Protocol for a Randomized Controlled Trial.
作者信息
Elbers Stefan, Pool Jan, Wittink Harriët, Köke Albère, Scheffer Else, Smeets Rob
机构信息
Lifestyle and Health Research Group, Healthy and Sustainable Living Research Centre, University of Applied Sciences Utrecht, Utrecht, Netherlands.
Department of Rehabilitation Medicine, Faculty of Health, Life Sciences and Medicine, Maastricht University, Maastricht, Netherlands.
出版信息
JMIR Res Protoc. 2020 Aug 18;9(8):e18632. doi: 10.2196/18632.
BACKGROUND
To facilitate adherence to adaptive pain management behaviors after interdisciplinary multimodal pain treatment, we developed a mobile health app (AGRIPPA app) that contains two behavior regulation strategies.
OBJECTIVE
The aims of this project are (1) to test the effectiveness of the AGRIPPA app on pain disability; (2) to determine the cost-effectiveness; and (3) to explore the levels of engagement and usability of app users.
METHODS
We will perform a multicenter randomized controlled trial with two parallel groups. Within the 12-month inclusion period, we plan to recruit 158 adult patients with chronic pain during the initial stage of their interdisciplinary treatment program in one of the 6 participating centers. Participants will be randomly assigned to the standard treatment condition or to the enhanced treatment condition in which they will receive the AGRIPPA app. Patients will be monitored from the start of the treatment program until 12 months posttreatment. In our primary analysis, we will evaluate the difference over time of pain-related disability between the two conditions. Other outcome measures will include health-related quality of life, illness perceptions, pain self-efficacy, app system usage data, productivity loss, and health care expenses.
RESULTS
The study was approved by the local Medical Research Ethics Committee in October 2019. As of March 20, 2020, we have recruited 88 patients.
CONCLUSIONS
This study will be the first step in systematically evaluating the effectiveness and efficiency of the AGRIPPA app. After 3 years of development and feasibility testing, this formal evaluation will help determine to what extent the app will influence the maintenance of treatment gains over time. The outcomes of this trial will guide future decisions regarding uptake in clinical practice.
TRIAL REGISTRATION
Netherlands Trial Register NL8076; https://www.trialregister.nl/trial/8076.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/18632.
背景
为促进患者在多学科综合疼痛治疗后坚持适应性疼痛管理行为，我们开发了一款移动健康应用程序（AGRIPPA应用程序），其中包含两种行为调节策略。
目的
本项目的目标是：（1）测试AGRIPPA应用程序对疼痛残疾的有效性；（2）确定成本效益；（3）探索应用程序用户的参与度和可用性水平。
方法
我们将进行一项有两个平行组的多中心随机对照试验。在12个月的纳入期内，我们计划在6个参与中心之一招募158名处于多学科治疗项目初始阶段的成年慢性疼痛患者。参与者将被随机分配到标准治疗组或强化治疗组，强化治疗组将使用AGRIPPA应用程序。从治疗项目开始到治疗后12个月对患者进行监测。在我们的主要分析中，我们将评估两组之间疼痛相关残疾随时间的差异。其他结果指标将包括健康相关生活质量、疾病认知、疼痛自我效能感、应用程序系统使用数据、生产力损失和医疗费用。
结果
该研究于2019年10月获得当地医学研究伦理委员会批准。截至2020年3月20日，我们已招募88名患者。
结论
本研究将是系统评估AGRIPPA应用程序有效性和效率的第一步。经过3年的开发和可行性测试，此次正式评估将有助于确定该应用程序在多大程度上会随着时间的推移影响治疗效果的维持。该试验的结果将指导未来关于在临床实践中应用的决策。
试验注册
荷兰试验注册中心NL8076；https://www.trialregister.nl/trial/8076。
国际注册报告识别码（IRRID）：DERR1-10.2196/18632。
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