JMIR Publications

ABSTRACT

Background:

Atrial fibrillation (AF) is a chronic cardiovascular condition that requires long-term adherence to medications and self-monitoring. Clinical trials for AF have had limited diversity by sex, race and ethnicity, and rural residence, thereby compromising integrity and generalizability of trial findings. Digital technology coupled with remote strategies has potential to increase recruitment of individuals from underrepresented demographic and geographic populations, resulting in increased trial diversity, and improvement in the generalizability of interventions for complex diseases such as AF.

Objective:

To summarize the successful architecture of a research program that used remote methods to enhance recruitment and engagement of diverse participants.

Methods:

We developed a programmatic architecture to conduct remote recruitment and assessments of individuals with AF in 2 complementary randomized clinical trials, funded by the National Institutes of Health, to test the effectiveness of a smartphone-based relational agent on adherence to oral anticoagulation. The study team engaged individuals with either rural or metropolitan residence receiving care for AF at health care settings who then underwent consent, baseline assessments, and randomization during a remotely conducted, telephone visit. Participants were randomized to the receive the relational agent intervention or control and subsequently received by mail a study smartphone with installed applications. Participants received a telephone-based training session on device and application usage accompanied by a booklet with pictures and instructions accessible for any level of health or digital literacy. The program included virtual methods to promote retention at 4-, 8-, and 12-month visits and incentivized return of the smartphone following study participation. The program demonstrated excellent participant engagement and retention throughout the duration of the clinical trials.

Results:

In total, 513 participants were enrolled, surpassing recruitment goals for the rural (n=270; target enrollment, 264) and metropolitan (n=243; target enrollment, 240) studies. Of those enrolled, 62% of participants were women; 30% of participants in the metropolitan study were non-white race, in contrast to 5% in the rural study. Among all participants, 45% had less than an associate’s degree and 44% were characterized as having limited health literacy. Intervention recipients receiving the relational agent used the agent median 95-98 (IQR, 56-109) across both studies and reported excellent satisfaction with it. Retention exceeded 85% at 12 months with study study phones used for median 3.3 (IQR, 1-5) participants.

Conclusions:

We report here the development and implementation of a programmatic architecture for the remote conduct of clinical trials. Our program successfully enhanced trial diversity and composition and applied while providing an innovative mobile health intervention to improve anticoagulation adherence in individuals with AF. Our methods provide a model for enhanced recruitment and engagement of diverse participants in cardiovascular trials. Clinical Trial: ClinicalTrials.gov ID NCT04076020 ClinicalTrials.gov ID NCT04075994