Zahradka Nicole, Pugmire Juliana, Lever Taylor Jessie, Wolfberg Adam, Wilkes Matt
Current Health Inc, Boston, MA, United States.
Current Health Ltd, Edinburgh, United Kingdom.
JMIR Form Res. 2022 Jul 29;6(7):e37832. doi: 10.2196/37832.
The SARS-CoV-2 (COVID-19) pandemic may accelerate the adoption of digital, decentralized clinical trials. Conceptual recommendations for digitalized and remote clinical studies and technology are available to enable digitalization. Fully remote studies may break down some of the participation barriers in traditional trials. However, they add logistical complexity and offer fewer opportunities to intervene following a technical failure or adverse event.
Our group designed an end-to-end digitalized clinical study protocol, using the Food and Drug Administration (FDA)-cleared Current Health (CH) remote monitoring platform to collect symptoms and continuous physiological data of individuals recently infected with COVID-19 in the community. The purpose of this work is to provide a detailed example of an end-to-end digitalized protocol implementation based on conceptual recommendations by describing the study setup in detail, evaluating its performance, and identifying points of success and failure.
Primary recruitment was via social media and word of mouth. Informed consent was obtained during a virtual appointment, and the CH-monitoring kit was shipped directly to the participants. The wearable continuously recorded pulse rate (PR), respiratory rate (RR), oxygen saturation (SpO), skin temperature, and step count, while a tablet administered symptom surveys. Data were transmitted in real time to the CH cloud-based platform and displayed in the web-based dashboard, with alerts to the study team if the wearable was not charged or worn. The study duration was up to 30 days. The time to recruit, screen, consent, set up equipment, and collect data was quantified, and advertising engagement was tracked with a web analytics service.
Of 13 different study advertisements, 5 (38.5%) were live on social media at any one time. In total, 38 eligibility forms were completed, and 19 (50%) respondents met the eligibility criteria. Of these, 9 (47.4%) were contactable and 8 (88.9%) provided informed consent. Deployment times ranged from 22 to 110 hours, and participants set up the equipment and started transmitting vital signs within 7.6 (IQR 6.3-10) hours of delivery. The mean wearable adherence was 70% (SD 19%), and the mean daily survey adherence was 88% (SD 21%) for the 8 participants. Vital signs were in normal ranges during study participation, and symptoms decreased over time.
Evaluation of clinical study implementation is important to capture what works and what might need to be modified. A well-calibrated approach to online advertising and enrollment can remove barriers to recruitment and lower costs but remains the most challenging part of research. Equipment was effectively and promptly shipped to participants and removed the risk of illness transmission associated with in-person encounters during a pandemic. Wearable technology incorporating continuous, clinical-grade monitoring offered an unprecedented level of detail and ecological validity. However, study planning, relationship building, and troubleshooting are more complex in the remote setting. The relevance of a study to potential participants remains key to its success.
严重急性呼吸综合征冠状病毒2（SARS-CoV-2，即新冠病毒）大流行可能会加速数字化、去中心化临床试验的采用。目前已有关于数字化和远程临床研究及技术的概念性建议，以推动数字化进程。完全远程的研究可能会打破传统试验中的一些参与障碍。然而，它们增加了后勤复杂性，并且在技术故障或不良事件发生后进行干预的机会较少。
我们团队设计了一个端到端的数字化临床研究方案，使用美国食品药品监督管理局（FDA）批准的Current Health（CH）远程监测平台，收集社区中近期感染新冠病毒个体的症状和连续生理数据。这项工作的目的是通过详细描述研究设置、评估其性能以及确定成功和失败的关键点，提供一个基于概念性建议的端到端数字化方案实施的详细示例。
主要通过社交媒体和口碑进行招募。在虚拟预约期间获得知情同意，然后将CH监测套件直接运送给参与者。可穿戴设备持续记录脉搏率（PR）、呼吸率（RR）、血氧饱和度（SpO）、皮肤温度和步数，同时平板电脑进行症状调查。数据实时传输到基于CH云的平台，并显示在基于网络的仪表板上，如果可穿戴设备未充电或未佩戴，会向研究团队发出警报。研究持续时间最长为30天。对招募、筛选、同意、设置设备和收集数据所需的时间进行了量化，并使用网络分析服务跟踪广告参与度。
在13个不同的研究广告中，任何时候都有5个（38.5%）在社交媒体上投放。总共完成了38份资格表格，19名（50%）受访者符合资格标准。其中，9名（47.4%）可以联系到，8名（88.9%）提供了知情同意。部署时间从22小时到110小时不等，参与者在收到设备后的7.6（四分位距6.3 - 10）小时内设置好设备并开始传输生命体征数据。8名参与者的可穿戴设备平均依从率为70%（标准差19%），每日调查平均依从率为88%（标准差21%）。在研究参与期间，生命体征处于正常范围，症状随时间减轻。
评估临床研究的实施情况对于了解哪些方面可行以及哪些方面可能需要改进很重要。一种经过精心校准的在线广告和招募方法可以消除招募障碍并降低成本，但仍然是研究中最具挑战性的部分。设备有效地及时运送给参与者，消除了大流行期间与面对面接触相关的疾病传播风险。结合连续临床级监测的可穿戴技术提供了前所未有的详细程度和生态效度。然而，在远程环境中，研究规划、关系建立和故障排除更为复杂。研究与潜在参与者的相关性仍然是其成功的关键。
