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Baca-Motes K, Edwards AM, Waalen J, et al. Digital recruitment and enrollment in a remote nationwide trial of screening for undiagnosed atrial fibrillation: Lessons from the randomized, controlled mSToPS trial. Contemp Clin Trials Commun. 2019;14:100318doi: 10.1016/j.conctc.2019.100318.
Baca-Motes, K., Edwards, A. M., Waalen, J., Edmonds, S., Mehta, R. R., Ariniello, L., Ebner, G. S., Talantov, D., Fastenau, J. M., Carter, C. T., Sarich, T. C., Felicione, E., Topol, E. J., & Steinhubl, S. R. (2019). Digital recruitment and enrollment in a remote nationwide trial of screening for undiagnosed atrial fibrillation: Lessons from the randomized, controlled mSToPS trial. Contemporary clinical trials communications, 14100318. https://doi.org/10.1016/j.conctc.2019.100318
Baca-Motes, Katie, et al. "Digital recruitment and enrollment in a remote nationwide trial of screening for undiagnosed atrial fibrillation: Lessons from the randomized, controlled mSToPS trial." Contemporary clinical trials communications vol. 14 (2019): 100318. doi: https://doi.org/10.1016/j.conctc.2019.100318
Baca-Motes K, Edwards AM, Waalen J, Edmonds S, Mehta RR, Ariniello L, Ebner GS, Talantov D, Fastenau JM, Carter CT, Sarich TC, Felicione E, Topol EJ, Steinhubl SR. Digital recruitment and enrollment in a remote nationwide trial of screening for undiagnosed atrial fibrillation: Lessons from the randomized, controlled mSToPS trial. Contemp Clin Trials Commun. 2019 Jan 07;14:100318. doi: 10.1016/j.conctc.2019.100318. eCollection 2019 Jun. PMID: 30656241; PMCID: PMC6329362.
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Contemp Clin Trials Commun. 2019 Jan 07;14:100318. doi: 10.1016/j.conctc.2019.100318. eCollection 2019 Jun.

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

Contemporary clinical trials communications

Katie Baca-Motes, Alison M Edwards, Jill Waalen, Shawn Edmonds, Rajesh R Mehta, Lauren Ariniello, Gail S Ebner, Dimitri Talantov, John M Fastenau, Chureen T Carter, Troy C Sarich, Elise Felicione, Eric J Topol, Steven R Steinhubl

Affiliations

  1. Scripps Research Translational Institute, 3344 N Torrey Pines Ct, Plaza Level, La Jolla, CA, 92037, USA.
  2. Wave Research Center, 8330 W Third St, Los Angeles, CA, 90048, USA.
  3. Healthagen Outcomes, 123 N Wacker Dr STE 650, Chicago, IL, 60606, USA.
  4. Janssen Scientific Affairs, 1125 Trenton-Harbourton Rd, PO Box 200, Titusville, NJ, 08560, USA.

PMID: 30656241 PMCID: PMC6329362 DOI: 10.1016/j.conctc.2019.100318

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

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