Participant Engagement and Adherence to Providing Smartwatch and Patient-Reported Outcome Data: Digital Tracking of Rheumatoid Arthritis Longitudinally (DIGITAL) Real-World Study.
Participant Engagement and Adherence to Providing Smartwatch and Patient-Reported Outcome Data: Digital Tracking of Rheumatoid Arthritis Longitudinally (DIGITAL) Real-World Study.
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DOI：
10.2196/44034
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发表时间：
2023-11-07
影响因子：
2.7
通讯作者：
Hayes, Virginia S.
中科院分区：
文献类型：
--
作者：
Nowell, William B.;Curtis, Jeffrey R.;Zhao, Hong;Xie, Fenglong;Stradford, Laura;Curtis, David;Gavigan, Kelly;Boles, Jessica;Clinton, Cassie;Lipkovich, Ilya;Venkatachalam, Shilpa;Calvin, Amy;Hayes, Virginia S.
关键词：
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，包括参与者需要持续提供试验数据。本研究旨在描述参与关节炎数字追踪 (DIGITAL) 研究的类风湿关节炎参与者的参与度、方案遵守情况和数据完整性。参与者被邀请参加这项基于应用程序的研究，其中包括为期 14 天的磨合和为期 84 天的主要研究。在磨合期，通过 ArthritisPower 移动应用程序收集数据，以提高应用程序的熟悉度并识别有动力参与的个人。成功完成磨合期的人会收到一块可穿戴智能手表，并向参与者发送自动和手动提示，提醒他们在主要研究期间分别完成应用程序输入或定期佩戴和同步设备。研究协调员监控参与者数据，并通过电子邮件、短信和电话联系参与者，以解决先验规则的遵守问题，其中连续丢失数据会触发参与者联系。在主要研究期间遵守数据收集的定义是，在 84 天的 70% 以上（每日 ePRO，≥80% 的每日智能手表数据）或 12 周中的至少 9 周（每周 ePRO）提供所要求的数据。在表示初步兴趣的 470 名参与者中，278 名 (59.1%) 完成了磨合期并有资格参加主要研究。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 遵守协议指定数据收集的定义，而每日 ePRO 的参与者则有 57.2% (159/278) 符合这一定义。对于智能手表数据，81.7% (227/278) 的参与者遵守协议指定的数据收集。总共有 52.9% (147/278) 的参与者达到了复合依从性。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，并让参与者有时间适应研究要求。为了优化依从性，可能需要自动或手动提示（即“是时候同步您的智能手表了”）。依从性因数据收集类型而异（例如，ePRO 与智能手表数据）。 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
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