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Publications

Journal Article Ahead of print

PubMed: 41875816 DOI: 10.1016/j.jacadv.2026.102662

Direct-to-Participant Enrollment in a Virtual Trial: Lessons Learned From the Heartline Study.

JACC Adv 5(4):102662

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

Affiliations

  • StopAfib.org, American Foundation for Women's Health, Decatur, Texas, USA.
  • Baim 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.
  • Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, USA.
  • Texas 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.
  • Division of Cardiology, Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.
  • John W. Deming Department of Medicine, Tulane University School of Medicine, New Orleans, Louisiana, USA.
  • Department of Medicine, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire, USA.
  • Providence Heart Institute, Portland, Oregon, USA.
  • Division of Cardiology, Department of Medicine, The University of Texas Southwestern Medical Center, Dallas, Texas, USA.
  • Scripps Research Translation Institute, La Jolla, California, USA.
  • Weldon School of Biomedical Engineering, Purdue University, West Lafayette, Indiana, USA.
  • Heartbeat Health, New York, New York, USA; Northwell, New Hyde Park, New York, USA.
  • Department of Medicine, NYU Grossman School of Medicine, New York, New York, USA.
  • Johnson & Johnson, Raritan, New Jersey, USA.
  • Johnson & Johnson, Titusville, New Jersey, USA.
  • Apple Inc. Cupertino, California, USA.
  • Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, USA.
  • University of Missouri-Kansas City's Healthcare Institute for Innovations in Quality and Saint Luke's Mid America Heart Institute, Kansas City, Missouri, USA.
  • Baim 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.

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).

MeSH

Atrial Fibrillation, Aged