Impact of Clinical Trial Virtualization on Recruitment in Underserved Communities for a Type 2 Diabetes mHealth Intervention

Poster Number: P182
Presentation Time: 05:00 PM - 06:30 PM

Abstract Keywords: Mobile Health, Diversity, Equity, Inclusion, Accessibility, and Health Equity, Evaluation, Health Equity
Primary Track: Applications
Programmatic Theme: Consumer Health Informatics

mHealth interventions are increasingly investigated in randomized clinical trials (RCTs), but representation of underserved populations remains a challenge. The move towards virtualization of clinical trials during the COVID-19 pandemic has highlighted the viability of decentralized clinical trials utilizing technology and, if adopted, may reduce barriers to participation in RCTs, even after the pandemic. In this study, we discuss an approach to virtualizing an RCT for a Type 2 Diabetes (T2DM) mHealth intervention for a medically underserved population. We compare demographic, clinical, and technical literacy characteristics of participants recruited in-person pre-pandemic versus virtually after the pandemic’s onset. Gender, education, age, HbA1c, employment status, technical literacy, combined family income, and language spoken at home were not significantly different between participants recruited in-person versus virtually. Race/ethnicity and birth location were significantly different, although this may be due to differences in demographic characteristics between patients receiving care at the two FQHCs pre-pandemic, and the remaining four FQHCs. Overall, our approach did not lead to any delays in recruitment or significant changes in the population recruited into the study. Consequently, these virtualization strategies may be used in future trials testing mHealth and other technological interventions, potentially reaching a broader and more diverse population, without exacerbating the under-representation of medically underserved populations or increasing the demands on busy, FQHCs and other under-resourced practices.

Speaker(s):
Elizabeth Campbell, MS, MSPH, PhD
Columbia University Department of Biomedical Informatics

Author(s):
Elizabeth Campbell, MS, MSPH, PhD - Columbia University Department of Biomedical Informatics; Pooja Desai, BA, MA - Columbia University Irving Medical Center; Arlene Smaldone, PhD - Columbia University; Haomiao Jia, PhD - Columbia University; Andrea Cassells, MPH - Clinical Directors Network; Jacqeline Cortez, MPH - Clinical Directors Network; TJ Lin, MPH - Clinical Directors Network; Jonathan Tobin, PhD - Clinical Directors Network; Lena Mamykina, PhD - Columbia University;