Building a digital health research platform to enable recruitment, enrollment, data collection and follow-up for a highly diverse longitudinal US cohort of 1 million people: The All of Us Research Program (Preprint)

Abstract

BACKGROUND Longitudinal cohort studies have traditionally relied on clinic-based recruitment models, which limit cohort diversity and the generalizability of research outcomes. Digital platforms can be used to increase participant access, improve study engagement, streamline data collection, and increase data quality; however, the efficacy and sustainability of digitally enabled studies rely heavily on the design, implementation, and management of the digital platform being used. OBJECTIVE The National Institutes of Health’s (NIH) All of Us Research Program (AOU) is an ongoing national, multiyear study aimed at building a large research cohort that reflects the diversity of the United States, including minority, health disparate, and other populations underrepresented in biomedical research (UBR). We sought to design and build a highly secure, privacy-preserving, validated, participant-centric digital research platform to recruit, enroll, and engage AOU participants from diverse backgrounds. METHODS AOU applied digital research methods to facilitate multi-site, hybrid, and remote study participation and multimodal data collection. We collaborated with community members, healthcare provider organizations, and NIH leadership to design, build, and validate a secure, feature-rich digital research platform based upon the core values of AOU. Participants were recruited by many methods, including in-person, print, and online digital campaigns. Participants accessed a secure digital research platform via web and mobile applications, either independently or with research staff support. The participant-facing tool facilitated electronic consent, multi-source data collection, including surveys, genomic results, wearables, electronic health records, and ongoing participant engagement. We also built tools for study staff and researchers to provide remote participant support, study workflow management, participant tracking, data analytics, data harmonization, and data management tools. RESULTS We built a secure, participant-centric digital research platform with engaging functionality used to recruit, engage, and collect data from diverse participants throughout the United States. As of April 2024, 87% of participants enrolled via the platform are from UBR groups, including racial and ethnic minorities (46%), rural dwelling individuals (8%), those over the age of 65 (31%), and individuals with low socioeconomic status (20%). CONCLUSIONS This digital research platform demonstrated successful use among diverse participants. We built a user-friendly, participant-centric digital platform with tools to enable engagement with individuals from different racial, ethnic, socioeconomic, and other UBR groups. These findings could be used as best practices for effective use of digital platforms to build and sustain cohorts of various study designs to increase engagement with diverse populations in health research. CLINICALTRIAL N/A