Strong Men, Strong Communities

This paper describes the revision of the in-person Strong Men, Strong Communities (SMSC) study to a remote protocol and highlights key successes, challenges, and critical lessons learned applicable to remote trial implementation. The SMSC study is the first randomized controlled trial to exclusively recruit American Indian and Alaska Native men into a diabetes prevention intervention. The five-year randomized controlled trial was in its 42nd month with 99 subjects enrolled when the COVID-19 pandemic ceased all in-person research. The study protocol was revised to accommodate remote implementation which required multiple protocol and procedural changes, including the use of Facebook for national recruitment of participants; alteration of the informed consent process; use of REDCap for independent participant completion of informed consent; revised eligibility criteria; and use of Zoom to deliver intervention classes. The remote study protocol proved superior to the in-person protocol in terms of recruitment, retention, engagement in intervention classes, and efficiency of data collection. Challenges to participation and retention included competing demands of participant's jobs as essential workers and for some, the trauma of the losing a loved one(s) to COVID-19. Future studies are needed to evaluate the effectiveness of a remote protocol in the absence of a pandemic

Alternative medicine · Data collection · Disease · Family medicine · Informed consent · Pandemic · Pathology · Randomized controlled trial · Ethics in Clinical Research · Health Policy Implementation Science · Medicine · Nursing · Telemedicine and Telehealth Implementation · Surgery