Direct-to-Participant Enrollment in a Virtual Trial
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).
Authors
- Katie Baca-Motes
- Scott Brancato
- Kevin F. Kwaku (ORCID: https://orcid.org/0000-0002-2509-319X)
- Mellanie True Hills (ORCID: https://orcid.org/0000-0001-8298-4418)
- Jill R. Applebaum
- Janeta Nikolovski
- Steven R. Steinhubl (ORCID: https://orcid.org/0000-0002-9256-7914)
- Michael Tarino
- Amish Asthana (ORCID: https://orcid.org/0000-0002-4597-5982)
- Serge Korjian (ORCID: https://orcid.org/0000-0003-0605-8337)
- Jeffrey L. Saver (ORCID: https://orcid.org/0000-0001-9141-2251)
- Simrati Kaul (ORCID: https://orcid.org/0009-0004-0206-9244)
- Oliver Aalami (ORCID: https://orcid.org/0000-0002-7799-2429)
- Cammie Tavakoli
- A. McB. Curtis
- Nieca Goldberg
- Kathleen Doran
- Kate Shute
- Leslie Saxon
- Eugene Scharf
- Nassir Marrouche
- Jeffrey Wessler
- Mithun Patel
- Keith C. Ferdinand
- Dereck Wentworth
- Dominic Angiolillo
- Christina Fanola
- Jared Bunch
- Eric Peterson
- Gerald Chi
- John A. Spertus
- Andrea Natale
- C. Michael Gibson
- Michael J. Cutler
- AnnMarie Navar
- Mikhail Kosiborod
- Rod Passman
- Roger Longman
- Jeremy Ruskin
- James Reiffel
- C.V. Damaraju
- W. Schuyler Jones
- Dhanunjaya Lakkireddy
- Jeff Olgin
- Amy Hughes
Institutions
- Dartmouth College (US)
- Tulane University (US)
- University of Southern California (US)
- Scripps Research Institute (US)
- Northwell Health (US)
- Beth Israel Deaconess Medical Center (US)
- Johnson & Johnson (United States) (US)
- Providence College (US)
- Purdue University West Lafayette (US)
- American Society for Reproductive Medicine (US)
- Baim Institute for Clinical Research (US)
- Texas Cardiac Arrhythmia (US)
- Hope Heart Institute (US)
- Apple (United States) (US)
- New York University (US)
- University at Buffalo, State University of New York (US)
- University of Missouri–Kansas City (US)
- The University of Texas Southwestern Medical Center (US)
Publication Details
- Journal
- JACC Advances
- Published
- 2026-03-23
- DOI
- https://doi.org/10.1016/j.jacadv.2026.102662
- Primary Topic
- Ethics in Clinical Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00