Digital recruitment and enrollment in a remote nationwide trial of screening for undiagnosed atrial fibrillation: Lessons from the randomized, controlled mSToPS trial

Abstract

Objectives: The advent of large databases, wearable technology, and novel communications methods has the potential to expand the pool of candidate research participants and offer them the flexibility and convenience of participating in remote research. However, reports of their effectiveness are sparse. We assessed the use of various forms of outreach within a nationwide randomized clinical trial being conducted entirely by remote means.

Methods: Candidate participants at possibly higher risk for atrial fibrillation were identified by means of a large insurance claims database and invited to participate in the study by their insurance provider. Enrolled participants were randomly assigned to one of two groups testing a wearable sensor device for detection of the arrhythmia.

Results: Over 10 months, the various outreach methods used resulted in enrollment of 2659 participants meeting eligibility criteria. Starting with a baseline enrollment rate of 0.8% in response to an email invitation, the recruitment campaign was iteratively optimized to ultimately include website changes and the use of a five-step outreach process (three short, personalized emails and two direct mailers) that highlighted the appeal of new technology used in the study, resulting in an enrollment rate of 9.4%. Messaging that highlighted access to new technology outperformed both appeals to altruism and appeals that highlighted accessing personal health information.

Conclusions: Targeted outreach, enrollment, and management of large remote clinical trials is feasible and can be improved with an iterative approach, although more work is needed to learn how to best recruit and retain potential research participants.

Trial registration: Clinicaltrials.govNCT02506244. Registered 23 July 2015.

Keywords: AF, atrial fibrillation; Clinical research; Clinical trials; Digital technology; ECG, electrocardiographic; ICF, informed consent form; Outreach; Remote enrollment; Remote monitoring; mSToPS, mHealth Screening to Prevent Strokes.

Figures

Fig. 1

Timeline for email and direct-mail campaigns.

Fig. 2

Enrollment rates by campaign type. The denominator for each group is the number of candidate participants who received each type of communication. PHI - personal health information. *p < 0.01 versus each of the other subject lines. †p < 0.01 versus Control and New Technology. ‡p < 0.01 versus Control.