Galarnyk Michael, Quer Giorgio, McLaughlin Kathryn, Ariniello Lauren, Steinhubl Steven R
Scripps Research Translational Institute, La Jolla, California, USA.
Digit Biomark. 2019 Dec 20;3(3):176-184. doi: 10.1159/000504838. eCollection 2019 Sep-Dec.
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.
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.
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.
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).
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.
如今广泛的创新型可穿戴传感器技术，使得以从前不可能的方式捕获和收集潜在重要的健康相关数据成为可能。这些传感器可应用于数字化临床试验，即在诊所外进行的临床试验，以收集研究参与者日常生活中的数据。然而，让参与者长时间激活、充电并佩戴数字传感器可能成为这些试验成功的重大障碍。
本研究从数据收集以及个体可分析数据方面，探讨了腕部可穿戴传感器有效性这一广泛问题。已同意参与无症状房颤筛查试验的个体，被直接发送了一款腕部可穿戴活动和心率追踪设备，以便在家庭环境中激活并使用。
总共230名中位年龄为71岁的参与者被要求尽可能频繁地佩戴腕带，日夜佩戴，至少进行4个月的监测期，尤其要在睡眠期间追踪心律。
在收到设备的个体中，43%从未传输过任何数据。使用该设备的人佩戴的中位时长约为15周（四分位距为2 - 24周），每周佩戴5.3天（四分位距为3.2 - 6.5天）。出于心律检测目的，个体所有记录数据中只有5.6%是可分析的（报告了逐搏间期）。
本研究提供了一些重要经验教训。研究表明，在老年人群中，尽管最初对收到一款消费级腕部健身设备充满热情，但很大一部分个体从未激活该设备。然而，研究还发现，对于大多数参与者来说，在家庭环境中无需临床监督就能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该设备。
