Digital Tracking of Rheumatoid Arthritis Longitudinally (DIGITAL) Using Biosensor and Patient-Reported Outcome Data: Protocol for a Real-World Study
Digital Tracking of Rheumatoid Arthritis Longitudinally (DIGITAL) Using Biosensor and Patient-Reported Outcome Data: Protocol for a Real-World Study
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DOI：
10.2196/14665
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发表时间：
2019-09-01
影响因子：
1.7
通讯作者：
Haynes, Virginia S.
中科院分区：
文献类型：
--
作者：
Nowell, William Benjamin;Curtis, Jeffrey R.;Haynes, Virginia S.
背景：类风湿性关节炎（RA）是一种症状随时间变化的疾病。典型的3至6个月的医生就诊间隔可能导致患者无法回忆或少报在此期间经历的症状。可穿戴数字技术可以定期被动收集患者的生物特征和活动数据。如果它被证明与患者报告结果（PRO）测量捕获的数据密切相关，则从可穿戴数字技术被动收集的信息可以作为客观代理或补充患者对RA症状的主观体验。目的：本研究的目的是表征从消费级智能手表收集的数字测量值与通过智能手机应用收集的RA疾病活动和其他PROs测量值的一致程度。方法：该观察性研究将对每位参与者持续6个月。我们的目标是招募250名关节炎诊断的注册者，他们将在研究期间佩戴智能手表。通过智能手机上的arthritis tispower移动应用程序，参与者将被提示回答前三个月每天和每周的电子PRO （ePRO）测量。结果：该研究于2018年12月启动，将需要长达18个月的时间才能完成。研究结果预计将于2021年底公布。结论：本研究的完成将在以下方面提供重要数据：(1)通过智能手机应用程序输入与疼痛、疲劳、身体功能和RA发作相关的ePROs的智能手表上被动收集的与活动、心率和睡眠相关的数字测量之间的关系；(2)确定智能手表和智能手机应用技术依从性的预测因素；(3)评估研究特定提醒对坚持使用智能手表的影响。
Background: Rheumatoid arthritis (RA) is a condition with symptoms that vary over time. The typical 3- to 6-month interval between physician visits may lead to patients failing to recall or underreporting symptoms experienced during the interim. Wearable digital technology enables the regular passive collection of patients' biometric and activity data. If it is shown to be strongly related to data captured by patient-reported outcome (PRO) measures, information collected passively from wearable digital technology could serve as an objective proxy or be complementary to patients' subjective experience of RA symptoms.Objective: The goal of this study is to characterize the extent to which digital measures collected from a consumer-grade smartwatch agree with measures of RA disease activity and other PROs collected via a smartphone app.Methods: This observational study will last 6 months for each participant. We aim to recruit 250 members of the ArthritisPower registry with an RA diagnosis who will receive a smartwatch to wear for the period of the study. From the ArthritisPower mobile app on their own smartphone device, participants will be prompted to answer daily and weekly electronic PRO (ePRO) measures for the first 3 months.Results: The study was launched in December 2018 and will require up to 18 months to complete. 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) the relationship between passively collected digital measures related to activity, heart rate, and sleep collected from a smartwatch with ePROs related to pain, fatigue, physical function, and RA flare entered via smartphone app; (2) determine predictors of adherence with smartwatch and smartphone app technology; and (3) assess the effect of study-specific reminders on adherence with the smartwatch.