一款用于类风湿性关节炎疾病活动自我监测以辅助患者自主护理的智能手机应用程序：一项随机对照试验方案

A Smartphone App for Self-Monitoring of Rheumatoid Arthritis Disease Activity to Assist Patient-Initiated Care: Protocol for a Randomized Controlled Trial.

作者信息

Seppen Bart F, L'ami Merel J, Duarte Dos Santos Rico Sharon, Ter Wee Marieke M, Turkstra Franktien, Roorda Leo D, Catarinella Fabio S, van Schaardenburg Dirkjan, Nurmohamed Michael T, Boers Maarten, Bos Wouter H

机构信息

Amsterdam Rheumatology and Immunology Center, Reade, Amsterdam, Netherlands.

Department of Rheumatology, VU Medical Center, Amsterdam UMC, Amsterdam, Netherlands.

出版信息

JMIR Res Protoc. 2020 Feb 19;9(2):e15105. doi: 10.2196/15105.

BACKGROUND

Telemedicine based on self-measurement of disease activity could be one of the key components to create the health care system of the future. Previous publications in various medical fields have shown that it is possible to safely telemonitor patients while reducing the number of outpatient clinic visits. For this purpose, we developed a mobile phone app for patients with rheumatoid arthritis (RA), which allows them to self-monitor their disease.

OBJECTIVE

The objective of this study is to assess the safety and efficacy of self-initiated care assisted by a smartphone app in patients with RA.

METHODS

This is a randomized controlled trial that will be performed for 1 year. A total of 176 patients with RA will be randomized to either self-initiated care with only one scheduled follow-up consultation assisted by our app or usual care. The coprimary outcome measures are the number of outpatient clinic consultations with a rheumatologist taking place during the trial period and the mean disease activity score as measured by the disease activity score 28 (DAS28) at 12 months. The secondary outcomes are patient satisfaction, adherence, patient empowerment, and cost evaluation of health care assisted by the app.

RESULTS

Recruitment started in May 2019, and up to 18 months will be required for completion of recruitment. Thus far, 78 patients have been randomized, and thus far, experiences with the app have been positive. The study results are expected to be published by the end of 2021.

CONCLUSIONS

The completion of this study will provide important data regarding the following: (1) safety of self-initiated care supported by a smartphone app in terms of DAS28 and (2) efficacy of lowering health care usage with this new strategy of providing health care.

TRIAL REGISTRATION

Netherlands Trial Register NL7715; https://www.trialregister.nl/trial/7715.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/15105.

背景

基于疾病活动自我测量的远程医疗可能是构建未来医疗保健系统的关键组成部分之一。先前在各个医学领域的出版物表明，在减少门诊就诊次数的同时对患者进行安全的远程监测是可行的。为此，我们为类风湿性关节炎（RA）患者开发了一款手机应用程序，使他们能够自我监测疾病。

目的

本研究的目的是评估智能手机应用程序辅助下的自我启动护理在类风湿性关节炎患者中的安全性和有效性。

方法

这是一项将进行1年的随机对照试验。总共176名类风湿性关节炎患者将被随机分为两组，一组接受仅由我们的应用程序辅助进行一次预定随访咨询的自我启动护理，另一组接受常规护理。共同主要结局指标是试验期间与风湿病专家进行门诊咨询的次数，以及在12个月时通过疾病活动评分28（DAS28）测量的平均疾病活动评分。次要结局指标包括患者满意度、依从性、患者赋权以及该应用程序辅助下的医疗保健成本评估。