Background The availability of a wide range of innovative wearable sensor technologies today allows for the ability to capture and collect potentially important health-related data in ways not previously possible. These sensors can be adopted in digitalized clinical trials, i.e., clinical trials conducted outside the clinic to capture data about study participants in their day-to-day life. However, having participants activate, charge, and wear the digital sensors for long hours may prove to be a significant obstacle to the success of these trials. Objective This study explores a broad question of wrist-wearable sensor effectiveness in terms of data collection as well as data that are analyzable per individual. The individuals who had already consented to be part of an asymptomatic atrial fibrillation screening trial were directly sent a wrist-wearable activity and heart rate tracker device to be activated and used in a home-based setting. Methods A total of 230 participants with a median age of 71 years were asked to wear the wristband as frequently as possible, night and day, for at least a 4-month monitoring period, especially to track heart rhythm during sleep. Results Of the individuals who received the device, 43% never transmitted any data. Those who used the device wore it a median of ∼15 weeks (IQR 2-24) and for 5.3 days (IQR 3.2-6.5) per week. For rhythm detection purposes, only 5.6% of all recorded data from individuals were analyzable (with beat-to-beat intervals reported). Conclusions This study provides some important learnings. It showed that in an older population, despite initial enthusiasm to receive a consumer-quality wrist-based fitness device, a large proportion of individuals never activated the device. However, it also found that for a majority of participants it was possible to successfully collect wearable sensor data without clinical oversight inside a home environment, and that once used, ongoing wear time was high. This suggests that a critical barrier to overcome when incorporating a wearable device into clinical research is making its initiation of use as easy as possible for the participant.

中文翻译：

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腕戴式智能手表在直接面向参与者的随机实用临床试验中的可用性


背景 如今，各种创新型可穿戴传感器技术的出现使得人们能够以以前不可能的方式捕获和收集潜在的重要健康相关数据。这些传感器可用于数字化临床试验，即在诊所外进行的临床试验，以捕获研究参与者日常生活的数据。然而，让参与者长时间激活、充电和佩戴数字传感器可能会成为这些试验成功的重大障碍。目的 本研究探讨了腕部可穿戴传感器在数据收集以及每个人可分析的数据方面的有效性的广泛问题。已经同意参加无症状心房颤动筛查试验的个人将被直接发送一个腕部可穿戴活动和心率追踪设备，以便在家庭环境中激活和使用。方法 总共 230 名平均年龄为 71 岁的参与者被要求尽可能频繁地佩戴腕带，日夜不停，持续至少 4 个月的监测期，特别是跟踪睡眠期间的心律。结果 在收到该设备的人中，43% 的人从未传输过任何数据。使用该设备的人平均佩戴该设备约 15 周（IQR 2-24），每周佩戴 5.3 天（IQR 3.2-6.5）。出于节律检测目的，所有记录的个人数据中只有 5.6% 是可分析的（报告了逐次心跳间隔）。结论 这项研究提供了一些重要的经验教训。研究表明，在老年人群中，尽管最初热衷于购买消费者品质的腕式健身设备，但很大一部分人从未激活过该设备。 然而，研究还发现，对于大多数参与者来说，无需在家庭环境中进行临床监督就可以成功收集可穿戴传感器数据，而且一旦使用，持续佩戴时间很长。这表明，将可穿戴设备纳入临床研究时需要克服的一个关键障碍是让参与者尽可能轻松地开始使用。