Direct-to-Participant Enrollment in a Virtual Trial
Year: 2026
Type: article
Abstract: BACKGROUND: Decentralized clinical trials using direct-to-participant recruitment can potentially engage large, representative participant pools. OBJECTIVES: The objective of the study was to share insights on multichannel strategies for participant recruitment in the decentralized Heartline Study, a randomized trial testing the impact of a mobile application-based heart health program with the electrocardiogram and Irregular Rhythm Notification features on an Apple Watch for early diagnosis, treatment, and outcomes of atrial fibrillation. METHODS: Eligible participants were U.S. adults aged ≥65 years with an iPhone and Medicare coverage. Multiple pathways for broad outreach were explored, including digital (eg, email, social media) and traditional channels (eg, direct mail, community outreach). Recruitment efforts were assessed and refined throughout the study to maximize reach. RESULTS: Across multiple channels, 321,272 Heartline Study applications were installed, with 34,244 participants (11%) completing enrollment (February 2020-December 2022) and 82% (28,155/34,244) completing baseline demographic assessments. Women accounted for 54.2% (15,258/28,155) of study participants; 93.0% identified as White (26,192/28,155), 2.8% Asian (781/28,155), 2.7% Black (747/28,155), and 2.5% Hispanic (699/28,155). Broad geographic representation throughout the United States was achieved. CONCLUSIONS: The Heartline Study demonstrated the ability to recruit large numbers of participants aged ≥65 years. A direct-to-participant approach across multiple channels achieved excellent gender and geographic diversity, enrolling a higher percentage of women than typical cardiology trials and participation from rural areas. However, less racial and ethnic representation was achieved, highlighting the need for additional strategies to meet this goal. Future trials may consider such multichannel recruitment approaches to support decentralized clinical trials. (A Study to Investigate if Early Atrial Fibrillation [AF] Diagnosis Reduces Risk of Events Like Stroke in the Real-World; NCT04276441).
Source: JACC Advances
Authors: Mellanie True Hills, Serge Korjian, Gerald Chi, Andrea Natale, Leslie Saxon, Keith C. Ferdinand, Kevin F. Kwaku, Scott Brancato, Amy Hughes, Katie Baca-Motes, Steven R. Steinhubl, Jeffrey Wessler, Nieca Goldberg, Anisha Asthana, Kate Shute, Jill Applebaum, Kathleen Doran, Janeta Nikolovski, Simrati Kaul, Dereck Wentworth, C.V. Damaraju, Cammie Tavakoli, Mithun Patel, Anne B. Curtis, John A. Spertus, C. Michael Gibson, C. Michael Gibson, John Spertus, Jared Bunch, Anne Curtis, W. Schuyler Jones, Dhanunjaya Lakkireddy, Nassir Marrouche, Rod Passman, Eric Peterson, Jeremy Ruskin, Steven Steinhubl, Leslie Saxon, Michael Tarino, Oliver Aalami, Dominic Angiolillo, Katie Baca-Motes, Scott Brancato, Michael J. Cutler, Christina Fanola, Keith C. Ferdinand, Nieca Goldberg, Mellanie True Hills, Mikhail Kosiborod, Kevin Kwaku, Roger Longman, AnnMarie Navar, Jeff Olgin, James Reiffel, Jeffrey L. Saver, Eugene Scharf, Jeffrey Wessler
Institutions: StopAfib.org, Beth Israel Deaconess Medical Center, Baim Institute for Clinical Research, Harvard University, University of Rome Tor Vergata, St David's Medical Center, Scripps Clinic, Texas Cardiac Arrhythmia, MetroHealth Medical Center, Case Western Reserve University, University of Southern California, Tulane University, Dartmouth College, The University of Texas Southwestern Medical Center, Scripps Research Institute, Purdue University West Lafayette, Northwell Health, New York University, Johnson & Johnson (United States), Apple (United States), University at Buffalo, State University of New York, Saint Luke's Hospital, University of Missouri–Kansas City
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,936
OpenAlex ID: W7140121467