Global Healthy Living Foundation, Upper Nyack, NY, United States.
University of Alabama at Birmingham, Birmingham, AL, United States.
JMIR Hum Factors. 2023 Nov 7;10:e44034. doi: 10.2196/44034.
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).
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/14665.
使用电子患者报告结局（ePRO）和可穿戴设备的数字健康研究带来了新的挑战，包括参与者需要持续提供试验数据。
本研究旨在描述类风湿关节炎患者参与数字关节炎纵向追踪（DIGITAL）研究的参与度、方案依从性和数据完整性。
参与者被邀请参与这项基于应用程序的研究，包括 14 天的预试验期和 84 天的主要研究期。在预试验期间，通过 ArthritisPower 移动应用程序收集数据，以增加对应用程序的熟悉度，并确定有意愿参与的人员。成功完成预试验期的参与者会收到一个可穿戴智能手表，并且在主要研究期间，会自动和手动提示参与者完成应用程序输入或定期佩戴和同步设备。研究协调员监测参与者的数据，并通过电子邮件、短信和电话联系参与者，根据预先设定的规则解决依从性问题，其中连续缺失数据的时间段会触发与参与者的联系。主要研究期间的数据采集依从性定义为提供请求数据的天数超过 84 天的 70%（每日 ePRO，每日智能手表数据≥80%）或至少 12 周中的 9 周（每周 ePRO）。
在表示最初兴趣的 470 名参与者中，有 278 名（59.1%）完成了预试验期并符合主要研究的条件。在 12 周的主要研究期间，87.4%（243/278）的参与者符合每周 ePRO 协议规定的数据采集依从性定义，57.2%（159/278）符合每日 ePRO。对于智能手表数据，278 名参与者中有 81.7%（227/278）符合协议规定的数据采集依从性。总的来说，52.9%（147/278）的参与者符合综合依从性。
与其他数字健康类风湿关节炎研究相比，较短的预试验期似乎有助于识别可能参与通过移动应用程序和可穿戴设备收集数据的研究的参与者，并使参与者有时间适应研究要求。自动化或手动提示（例如，“现在是同步智能手表的时候了”）可能是优化依从性所必需的。依从性因数据采集类型而异（例如，ePRO 与智能手表数据）。
