Peer-Reviewed Publication
JACC Adv2026;5(4):102662.April 1, 2026Journal Article
Direct-to-Participant Enrollment in a Virtual Trial: Lessons Learned From the Heartline Study.
Mellanie True Hills1, Serge Korjian2, Gerald Chi3, Andrea Natale4, Leslie Saxon5, Keith C Ferdinand6, Kevin F Kwaku7, Scott Brancato8, Amy Hughes9, Katie Baca-Motes10, Steven R Steinhubl11, Jeffrey Wessler12, Nieca Goldberg13, Anisha Asthana14, Kate Shute14, Jill Applebaum14, Kathleen Doran14, Janeta Nikolovski14, Simrati Kaul15, Dereck Wentworth15, C V Damaraju15, Cammie Tavakoli16, Mithun Patel16, Anne B Curtis17, John A Spertus18, C Michael Gibson19,
1StopAfib.org, American Foundation for Women's Health, Decatur, Texas, USA.
2Baim Institute for Clinical Research, Boston, Massachusetts, USA; Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, USA. Electronic address: serge.korjian@baiminstitute.org.
3Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, USA.
4Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas, USA; Interventional Electrophysiology, Scripps Clinic, San Diego, California, USA; Metro Health Medical Center, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA; Department of Biomedicine and Prevention, Division of Cardiology, University of Tor Vergata, Rome, Italy.
5Division of Cardiology, Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.
6John W. Deming Department of Medicine, Tulane University School of Medicine, New Orleans, Louisiana, USA.
7Department of Medicine, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire, USA.
8Providence Heart Institute, Portland, Oregon, USA.
9Division of Cardiology, Department of Medicine, The University of Texas Southwestern Medical Center, Dallas, Texas, USA.
10Scripps Research Translation Institute, La Jolla, California, USA.
11Weldon School of Biomedical Engineering, Purdue University, West Lafayette, Indiana, USA.
12Heartbeat Health, New York, New York, USA; Northwell, New Hyde Park, New York, USA.
13Department of Medicine, NYU Grossman School of Medicine, New York, New York, USA.
14Johnson & Johnson, Raritan, New Jersey, USA.
15Johnson & Johnson, Titusville, New Jersey, USA.
16Apple Inc., Cupertino, California, USA.
17Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, USA.
18University of Missouri-Kansas City's Healthcare Institute for Innovations in Quality and Saint Luke's Mid America Heart Institute, Kansas City, Missouri, USA.
19Baim Institute for Clinical Research, Boston, Massachusetts, USA; Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, USA. Electronic address: michael.gibson@baiminstitute.org.
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 e…
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