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 in the All of Us Research Program: Design and Implementation Study

Abstract

Background: Longitudinal cohort studies have traditionally relied on clinic-based recruitment models, which limit cohort diversity and the generalizability of research outcomes. Digital research 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: We sought to design and build a secure, privacy-preserving, validated, participant-centric digital health research platform (DHRP) to recruit and enroll participants, collect multimodal data, and engage participants from diverse backgrounds in the National Institutes of Health's (NIH) All of Us Research Program (AOU). AOU is an ongoing national, multiyear study aimed to build a research cohort of 1 million participants that reflects the diversity of the United States, including minority, health-disparate, and other populations underrepresented in biomedical research (UBR).

Methods: We collaborated with community members, health care provider organizations (HPOs), and NIH leadership to design, build, and validate a secure, feature-rich digital platform to facilitate multisite, hybrid, and remote study participation and multimodal data collection in AOU. Participants were recruited by in-person, print, and online digital campaigns. Participants securely accessed the DHRP via web and mobile apps, either independently or with research staff support. The participant-facing tool facilitated electronic informed consent (eConsent), multisource data collection (eg, surveys, genomic results, wearables, and electronic health records [EHRs]), and ongoing participant engagement. We also built tools for research staff to conduct remote participant support, study workflow management, participant tracking, data analytics, data harmonization, and data management.

Results: We built a secure, participant-centric DHRP with engaging functionality used to recruit, engage, and collect data from 705,719 diverse participants throughout the United States. As of April 2024, 87% (n=613,976) of the participants enrolled via the platform were from UBR groups, including racial and ethnic minorities (n=282,429, 46%), rural dwelling individuals (n=49,118, 8%), those over the age of 65 years (n=190,333, 31%), and individuals with low socioeconomic status (n=122,795, 20%).

Conclusions: We built a participant-centric digital platform with tools to enable engagement with individuals from different racial, ethnic, and socioeconomic backgrounds and other UBR groups. This DHRP demonstrated successful use among diverse participants. These findings could be used as best practices for the effective use of digital platforms to build and sustain cohorts of various study designs and increase engagement with diverse populations in health research.

Keywords: biomedical research; cohort studies; database management system; decentralization; digital health technology; health disparities; longitudinal studies; minority populations; precision medicine; vulnerable populations.

Figure 1

Illustration of how an all-in-one platform requires broad functionality to accommodate the varying dimensions of complexities for different study protocols.

Figure 2

AOU core values were used to develop key design features of the DHRP. AOU: All of Us Research Program; DHRP: digital health research platform; HIPAA: Health Insurance Portability and Accountability Act.

Figure 3

Integration of DHRP tools within the AOU digital infrastructure. AOU: All of Us Research Program; DHRP: digital health research platform; EDC: electronic data capture.

Figure 4

Schematic of the DHRP end-to-end unified data informatics platform and its PXM, RC, and DX tools facilitating collaboration among research teams in a large multisite consortium. DHRP: digital health research platform; DX: Data Explorer; PHI: protected health information; PXM: Participant Experience Manager; RC: Research Cloud.

Figure 5

Screenshot of the PXM dashboard. PXM: Participant Experience Management.

Figure 6

Geographic distribution of AOU participants enrolled through the DHRP by US state as of March 21, 2024. State enrollment varied from 13.2% (n=86,803) in California to 0.1% (n=706) in New York. The western region had the highest enrollment (28.1%). AOU: All of Us Research Program; DHRP: digital health research platform.

Figure 7

Heat map showing cross-sectional use of CATI by age and education level. CATI: computer-assisted telephone interviewing; GED: General Educational Development.

Figure 8

Heat maps showing cross-sectional use of CATI by age and income. CATI: computer-assisted telephone interviewing.

Figure 9

Heat maps showing cross-sectional use of CATI by age, race, and ethnicity. AIAN: American Indian or Alaska Native; CATI: computer-assisted telephone interviewing; NHPI: Native Hawaiian or Pacific Islander; MENA: Middle Eastern or North African.