Reale Carrie, Faiman Janelle, Beebe Russ, Marlin Jessica S, Collins Sean, Boulware David R, Dunsmore Sarah E, Thicklin Florence, Stewart Thomas G, Hernandez Adrian F, Rothman Russell L, Lindsell Christopher J, Anders Shilo
Center for Research and Innovation in Systems Safety (CRISS), Vanderbilt University Medical Center, Nashville, TN, USA.
Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, Nashville, TN, USA.
J Clin Transl Sci. 2025 Apr 16;9(1):e121. doi: 10.1017/cts.2025.69. eCollection 2025.
Inadequate recruitment and retention impede clinical trial goals. Emerging decentralized clinical trials (DCTs) leveraging digital health technologies (DHTs) for remote recruitment and data collection aim to address barriers to participation in traditional trials. The ACTIV-6 trial is a DCT using DHTs, but participants' experiences of such trials remain largely unknown. This study explored participants' perspectives of the ACTIV-6 DCT that tested outpatient COVID-19 therapeutics.
Participants in the ACTIV-6 study were recruited via email to share their day-to-day trial experiences during 1-hour virtual focus groups. Two human factors researchers guided group discussions through a semi-structured script that probed expectations and perceptions of study activities. Qualitative data analysis was conducted using a grounded theory approach with open coding to identify key themes.
Twenty-eight ACTIV-6 study participants aged 30+ years completed a virtual focus group including 1-4 participants each. Analysis yielded three major themes: perceptions of the DCT experience, study activity engagement, and trust. Participants perceived the use of remote DCT procedures supported by DHTs as an acceptable and efficient method of organizing and tracking study activities, communicating with study personnel, and managing study medications at home. Use of social media was effective in supporting geographically dispersed participant recruitment but also raised issues with trust and study legitimacy.
While participants in this qualitative study viewed the DCT-with-DHT approach as reasonably efficient and engaging, they also identified challenges to address. Understanding facilitators and barriers to DCT participation and DHT interaction can help improve future research design.
招募不足和留存率低阻碍了临床试验目标的实现。新兴的去中心化临床试验（DCT）利用数字健康技术（DHT）进行远程招募和数据收集，旨在解决参与传统试验的障碍。ACTIV-6试验是一项使用DHT的DCT，但此类试验中参与者的体验仍 largely unknown。本研究探讨了参与测试门诊COVID-19治疗方法的ACTIV-6 DCT的参与者的观点。
通过电子邮件招募ACTIV-6研究的参与者，让他们在1小时的虚拟焦点小组中分享日常试验经历。两名人为因素研究人员通过一个半结构化脚本指导小组讨论，该脚本探讨了对研究活动的期望和看法。使用扎根理论方法进行定性数据分析，通过开放编码确定关键主题。
28名年龄在30岁及以上的ACTIV-6研究参与者完成了一个虚拟焦点小组，每个小组有1-4名参与者。分析得出三个主要主题：对DCT体验的看法、研究活动参与度和信任。参与者认为，由DHT支持的远程DCT程序的使用是组织和跟踪研究活动、与研究人员沟通以及在家管理研究药物的可接受且有效的方法。社交媒体的使用有效地支持了地理上分散的参与者招募，但也引发了信任和研究合法性方面的问题。
虽然这项定性研究中的参与者认为DCT与DHT相结合的方法相当有效且有吸引力，但他们也指出了需要解决的挑战。了解DCT参与和DHT交互的促进因素和障碍有助于改进未来的研究设计。
