背景:使用电子患者报告结果(ePro)和可穿戴设备的数字健康研究带来了新的挑战,包括参与者需要始终如一地提供试验数据.
目的:本研究旨在表征参与,遵守协议,参与关节炎纵向数字追踪(DIGITAL)研究的类风湿关节炎参与者的数据和完整性。
方法:参与者被邀请参加这项基于应用程序的研究,其中包括14天的磨合和84天的主要研究。在磨合期,数据是通过ArthritisPower移动应用程序收集的,以增加应用程序的熟悉度,并确定有动机参与的个人。磨合期的成功完成者邮寄了可穿戴智能手表,并向参与者发送了自动和手动提示,提醒他们完成应用程序输入或定期佩戴和同步设备,分别,在主要研究过程中。研究协调员监控参与者数据,并通过电子邮件与参与者联系。短信,并通过电话根据先验规则解决遵守问题,其中丢失数据的连续跨度触发了参与者联系。在主要研究期间坚持数据收集被定义为在84天中提供>70%的所需数据(每日ePRO,每日智能手表数据≥80%)或12周至少9周(每周ePRO)。
结果:在表达最初兴趣的470名参与者中,278(59.1%)完成了磨合期,并符合主要研究的条件。在为期12周的主要研究期间,87.4%(243/278)的参与者符合每周ePRO遵守协议规定的数据收集的定义,57.2%(159/278)的每日ePRO这样做。对于智能手表数据,81.7%(227/278)的参与者遵守协议规定的数据收集。总的来说,52.9%(147/278)的参与者符合复合依从性。
结论:与其他数字健康类风湿性关节炎研究相比,较短的磨合期似乎有助于识别可能参与研究的参与者,该研究通过移动应用程序和可穿戴设备收集数据,并为参与者提供适应研究要求的时间.自动或手动提示(即,\“是时候同步您的智能手表\”)可能是优化依从性的必要条件。遵守情况因数据收集类型而异(例如,ePROvs智能手表数据)。
■RR2-10.2196/14665。
Digital health studies using electronic patient-reported outcomes (ePROs) and wearables bring new challenges, including the need for participants to consistently provide
trial data.
This study aims to characterize the engagement, protocol adherence, and data completeness among participants with rheumatoid arthritis enrolled in the Digital Tracking of Arthritis Longitudinally (DIGITAL)
study.
Participants were invited to participate in this app-based
study, which included a 14-day run-in and an 84-day main
study. In the run-in period, data were collected via the ArthritisPower mobile app to increase app familiarity and identify the individuals who were motivated to participate. Successful completers of the run-in period were mailed a wearable smartwatch, and automated and manual prompts were sent to participants, reminding them to complete app input or regularly wear and synchronize devices, respectively, during the main study. Study coordinators monitored participant data and contacted participants via email, SMS text messaging, and phone to resolve adherence issues per a priori rules, in which consecutive spans of missing data triggered participant contact. Adherence to data collection during the main
study period was defined as providing requested data for >70% of 84 days (daily ePRO, ≥80% daily smartwatch data) or at least 9 of 12 weeks (weekly ePRO).
Of the 470 participants expressing initial interest, 278 (59.1%) completed the run-in period and qualified for the main study. Over the 12-week main study period, 87.4% (243/278) of participants met the definition of adherence to protocol-specified data collection for weekly ePRO, and 57.2% (159/278) did so for daily ePRO. For smartwatch data, 81.7% (227/278) of the participants adhered to the protocol-specified data collection. In total, 52.9% (147/278) of the participants met composite adherence.
Compared with other digital health rheumatoid arthritis studies, a short run-in period appears useful for identifying participants likely to engage in a study that collects data via a mobile app and wearables and gives participants time to acclimate to study requirements. Automated or manual prompts (ie, \"It\'s time to sync your smartwatch\") may be necessary to optimize adherence. Adherence varies by data collection type (eg, ePRO vs smartwatch data).
RR2-10.2196/14665.