Enrollment and Retention of Participants in Remote Digital Health Studies: Scoping Review and Framework Proposal

Abstract

Background: Digital technologies are increasingly used in health research to collect real-world data from wider populations. A new wave of digital health studies relies primarily on digital technologies to conduct research entirely remotely. Remote digital health studies hold promise to significant cost and time advantages over traditional, in-person studies. However, such studies have been reported to typically suffer from participant attrition, the sources for which are still largely understudied.

Objective: To contribute to future remote digital health study planning, we present a conceptual framework and hypotheses for study enrollment and completion. The framework introduces 3 participation criteria that impact remote digital health study outcomes: (1) participant motivation profile and incentives or nudges, (2) participant task complexity, and (3) scientific requirements. The goal of this study is to inform the planning and implementation of remote digital health studies from a person-centered perspective.

Methods: We conducted a scoping review to collect information on participation in remote digital health studies, focusing on methodological aspects that impact participant enrollment and retention. Comprehensive searches were conducted on the PubMed, CINAHL, and Web of Science databases, and additional sources were included in our study from citation searching. We included digital health studies that were fully conducted remotely, included information on at least one of the framework criteria during recruitment, onboarding or retention phases of the studies, and included study enrollment or completion outcomes. Qualitative analyses were performed to synthesize the findings from the included studies.

Results: We report qualitative findings from 37 included studies that reveal high values of achieved median participant enrollment based on target sample size calculations, 128% (IQR 100%-234%), and median study completion, 48% (IQR 35%-76%). Increased median study completion is observed for studies that provided incentives or nudges to extrinsically motivated participants (62%, IQR 43%-78%). Reducing task complexity for participants in the absence of incentives or nudges did not improve median study enrollment (103%, IQR 102%-370%) or completion (43%, IQR 22%-60%) in observational studies, in comparison to interventional studies that provided more incentives or nudges (median study completion rate of 55%, IQR 38%-79%). Furthermore, there were inconsistencies in measures of completion across the assessed remote digital health studies, where only around half of the studies with completion measures (14/27, 52%) were based on participant retention throughout the study period.

Conclusions: Few studies reported on participatory factors and study outcomes in a consistent manner, which may have limited the evidence base for our study. Our assessment may also have suffered from publication bias or unrepresentative study samples due to an observed preference for participants with digital literacy skills in digital health studies. Nevertheless, we find that future remote digital health study planning can benefit from targeting specific participant profiles, providing incentives and nudges, and reducing study complexity to improve study outcomes.

Keywords: conceptual framework; digital epidemiology; digital health; health outcome; interventional study; participant recruitment; population-based digital health; remote clinical trials; remote cohorts; remote digital health studies; user-centered design.