Impact of clinical trial virtualization on recruitment in underserved communities for a type 2 diabetes mHealth...

Approaches to randomized clinical trial (RCT) implementation changed during the COVID-19 pandemic as clinical trials transitioned to largely virtual implementation which may continue in the future. Without careful consideration, virtual RCTs may exacerbate the historical under-representation of women, the elderly, and racial and ethnic minorities that has occurred in the past. The following study presents an approach to virtualizing an RCT for an mHealth intervention.

Study participants were recruited from Federally Qualified Health Centers in medically underserved areas of the New York City metropolitan area. Recruitment began in January 2020 but was paused in March 2020 due to the COVID-19 pandemic's onset. The research team developed a virtual protocol for recruitment, onboarding, and study implementation.

Study participants were predominantly from immigrant, low-income, and racial and ethnic minority groups. Our virtualization approach included an easier-to-understand consent form, expanded virtual training materials, and greater one-on-one attention during training. Despite the transition to virtual protocols, we did not detect statistically significant differences in key demographic characteristics, clinical factors, or mobile device proficiency between recruitment modalities, though the small in-person sample size (n = 21) limits definitive conclusions about selection bias.

Our study represents an early investigation into how the change from in-person clinical trial recruitment and study implementation to virtual during the COVID-19 pandemic may impact recruitment of participants from medically underserved communities into RCTs.

This approach may be used in future trials testing mHealth and other technological interventions without exacerbating the under-representation of medically underserved populations.