The DCM Project Portal: A direct-to-participant platform of The DCM Research Project

Abstract

Study objective: To develop a digital platform to conduct family-based, dilated cardiomyopathy (DCM) genetic research.

Design: Innovative approaches are needed to achieve large family enrollment targets. The DCM Project Portal, a direct-to-participant electronic recruitment, consent, and communication tool, was designed using prior experience with traditional enrollment methods, characteristics and feedback of current participants, and internet access of the US population.

Participants: DCM patients (probands) and their family members.

Results: The portal was designed as a self-guided, three module (registration, eligibility, and consent) process with internally created supporting informational and messaging resources integrated throughout. The experience can be tailored to user type and the format adapted with programmatic growth. Characteristics of participants of the recently completed DCM Precision Medicine Study were assessed as an exemplary user population. A majority of the diverse (34% non-Hispanic Black (NHE-B), 9.1% Hispanic; 53.6% female) proband (n=1223) and family members (n=1781) participants aged ≥18 years reported not at all or rarely having problems learning about their health from written information (81%) and a high confidence in completing medical forms (77.2% very much or often confident). A majority of participants across age and race-ethnicity groups reported internet access, with highest rates of no reported access in those ≥77 years, NHE-B, and Hispanic, which reflects patterns similar to rates reported by the US Census Bureau as of 2021.

Conclusions: Digital enrollment tools offer opportunity to improve access and efficiency. The portal is an example of a digital approach to family-based genetic research.

Keywords: Research design; dilated cardiomyopathy; family members.

Figure 1.

Reported internet access in the US population in 2019 and 2021 according to US Census Data The percentage of individuals in the population within generational age groups by year of birth, self-identified race, and self-identified ethnicity that reported having access to internet at home according to The United States Census Bureau. Individuals who reported having access to the internet, with or without paying a cell phone company or internet service provider, in 2019 (orange) are shown with the increase for each subgroup from 2019 to 2021 shown in blue. The years 2019 and 2021 were selected to demonstrate any increase in access before and after the COVID-19 pandemic, which increased across all groups. The percentage reporting to have no access at home as of 2021 is shown in gray and those living in group quarters or housing units vacant at the time of data collection in 2021 are shown in yellow. Generational age groups including generations with individuals ≥18 years of age as of 2023 are presented, including Generation Z (born 2012–1997), Millennials (1996–81), Generation X (1980–65), Baby Boomer (1964–46), and Silent Generation (1945–28). The data included in this figure are also provided in a table format in Supplementary Table S2.

Figure 2.

The Three Step DCM Project Portal Process by User Type The three-step process tailored to the user type is shown, including (1) Registration, (2) Eligibility, and (3) Consent Modules. The Registration step establishes an account by collecting basic demographic and contact information, permission to communicate through text messaging, and preferred language. To complete Registration, users are required to create a password so that they may exit and return to their account. If the registered user does not provide skip code indicating that they are eligible, they are directed to the Eligibility Module. This section consists of a series of eight self-guided “yes,” “no,” or “not sure” questions adapted from the study’s eligibility criteria (Supplementary Material). Upon completion, logic is built to determine in real time if a user is eligible, ineligible, or has inconclusive eligibility, which requires additional staff review to determine the status. The Consent Module for eligible individuals is similarly built, consisting of a 15-item design with seven questions and eight acknowledgment statements. Upon completion of the Consent Module an electronic signature is collected. Once a user has completed the process specific to their user type, as indicated by the four colored pathways shown, they have full access to the user features of the portal.