Evidence map›Paper›PMID 41875816›Full record

ArticleJACC. Advances2026

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

Mellanie True Hills, Serge Korjian, Gerald Chi, Andrea Natale, Leslie Saxon, Keith C Ferdinand, Kevin F Kwaku, Scott Brancato, Amy Hughes, Katie Baca-Motes and 17 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in JACC. Advances, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04276441 (HEARTLINE - A Heart Health Study Using Digital Technology to Investigate if Early AF Diagnosis Reduces the Risk of Thromboembolic Events Like Stroke IN the Real-world Environment), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04276441 completednot on this map

HEARTLINE - A Heart Health Study Using Digital Technology to Investigate if Early AF Diagnosis Reduces the Risk of Thromboembolic Events Like Stroke IN the Real-world Environment

TypeobservationalSponsorJanssen Scientific Affairs, LLCRan2020 to 2025Enrolled34,244ConditionsAtrial FibrillationArmsHeart healthy Engagement Program with the Apple Watch Series 5 or later, Anti-Coagulation Adherence Module with the Apple Watch Series 5 or later
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors.

Mellanie True HillsStopAfib.org, American Foundation for Women's Health, Decatur, Texas, USA.
Serge KorjianBaim 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.
Gerald ChiDivision of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, USA.
Andrea NataleTexas 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.
Leslie SaxonDivision of Cardiology, Department of Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.
Keith C FerdinandJohn W. Deming Department of Medicine, Tulane University School of Medicine, New Orleans, Louisiana, USA.
Kevin F KwakuDepartment of Medicine, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire, USA.
Scott BrancatoProvidence Heart Institute, Portland, Oregon, USA.
Amy HughesDivision of Cardiology, Department of Medicine, The University of Texas Southwestern Medical Center, Dallas, Texas, USA.
Katie Baca-MotesScripps Research Translation Institute, La Jolla, California, USA.
Steven R SteinhublWeldon School of Biomedical Engineering, Purdue University, West Lafayette, Indiana, USA.
Jeffrey WesslerHeartbeat Health, New York, New York, USA; Northwell, New Hyde Park, New York, USA.
Nieca GoldbergDepartment of Medicine, NYU Grossman School of Medicine, New York, New York, USA.
Anisha AsthanaJohnson & Johnson, Raritan, New Jersey, USA.
Kate ShuteJohnson & Johnson, Raritan, New Jersey, USA.
Jill ApplebaumJohnson & Johnson, Raritan, New Jersey, USA.
Kathleen DoranJohnson & Johnson, Raritan, New Jersey, USA.
Janeta NikolovskiJohnson & Johnson, Raritan, New Jersey, USA.
Simrati KaulJohnson & Johnson, Titusville, New Jersey, USA.
Dereck WentworthJohnson & Johnson, Titusville, New Jersey, USA.
C V DamarajuJohnson & Johnson, Titusville, New Jersey, USA.
Cammie TavakoliApple Inc., Cupertino, California, USA.
Mithun PatelApple Inc., Cupertino, California, USA.
Anne B CurtisDepartment of Medicine, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, USA.
John A SpertusUniversity of Missouri-Kansas City's Healthcare Institute for Innovations in Quality and Saint Luke's Mid America Heart Institute, Kansas City, Missouri, USA.
C Michael GibsonBaim 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.
Heartline Executive Committee and Steering Committee

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDecentralized clinical trials using direct-to-participant recruitment can potentially engage large, representative participant pools.

objectivesThe 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.

methodsEligible 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.

resultsAcross 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.

conclusionsThe 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).

Indexed as

atrial fibrillationheartlinerecruitment strategiesRUCA representationvirtual trial

Identifiers

PMID41875816
PMCPMC13049618

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.