Osher Center for Integrative Health, University of California, San Francisco, United States of America.
Department of Psychiatry and Behavioral Sciences, University of California, San Francisco, United States of America.
Contemp Clin Trials. 2024 Feb;137:107425. doi: 10.1016/j.cct.2023.107425. Epub 2023 Dec 24.
There are unique challenges that arise from participating in remote clinical trials. Broadly, findings suggest that participants enrolled in digital intervention trials are more likely to disengage or prematurely dropout than participants in face-to-face trials. Thus, optimizing contact with participants via video-conferencing platforms to build rapport and encourage commitment to the study is critical. Still, challenges with video-conferencing visits can pose challenges. Some of these challenges include a lack of clarity about study requirements, difficulties demonstrating staff engagement and building rapport, and the technical challenges of using video-conferencing software. These challenges can affect participant retention, study validity, and the willingness of underserved groups to participate in research. In the context of a remote randomized clinical trial evaluating a digital intervention for prenatal insomnia, we discuss strategies used to counteract these challenges, including the use of virtual orientation sessions, and practical recommendations to improve staff engagement with participants. These findings are relevant to research teams conducting remote clinical trials, especially those seeking to recruit and retain participants from populations currently and historically underrepresented in research.
远程临床试验会面临一些独特的挑战。研究结果表明,与面对面试验相比,数字干预试验的参与者更有可能脱离或提前退出试验。因此,通过视频会议平台与参与者保持密切联系,建立融洽关系并鼓励他们承诺参与研究至关重要。然而,视频会议访问仍可能会面临挑战。其中一些挑战包括:研究要求不明确、难以展示员工的投入度并建立融洽关系,以及使用视频会议软件的技术难题。这些挑战可能会影响参与者的保留率、研究的有效性,以及服务不足群体参与研究的意愿。在一项评估针对产前失眠的数字干预措施的远程随机临床试验的背景下,我们讨论了用于应对这些挑战的策略,包括使用虚拟介绍会议,以及提高员工与参与者互动的实用建议。这些发现与开展远程临床试验的研究团队相关,特别是那些希望招募和保留目前和历史上在研究中代表性不足的人群的团队。