Evidence map›Paper›PMID 40839901›Full record

ArticleJACC. Advances2025

The Heartline Experience: Achieving Long-Term Participant Engagement in Digital Health Technology Trials.

Janeta Nikolovski, Ann Marie Navar, Steven Steinhubl, Katie Baca-Motes, Anne B Curtis, Eric D Peterson, Dhanunjaya Lakkireddy, Michael Tarino, Stephanie Juan, Chandrasekhar Rao Venkata Damaraju and 7 more

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

Article in JACC. Advances, 2025. 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 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. 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

17 authors.

Janeta NikolovskiJohnson & Johnson, Raritan, New Jersey, USA. Electronic address: janetanik003@gmail.com.
Ann Marie NavarDivision of Cardiology, Department of Medicine, The University of Texas Southwestern Medical Center, Dallas, Texas, USA.
Steven SteinhublWeldon School of Biomedical Engineering, Purdue University, West Lafayette, Indiana, USA.
Katie Baca-MotesScripps Research Translational Institute, La Jolla, California, USA.
Anne B CurtisDepartment of Medicine, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, USA.
Eric D PetersonDivision of Cardiology, Department of Medicine, The University of Texas Southwestern Medical Center, Dallas, Texas, USA.
Dhanunjaya LakkireddyKansas City Heart Rhythm Institute, HCA Midwest Health, Overland Park, Kansas, USA.
Michael TarinoTiltas Solutions LLC, Union, Washington, USA.
Stephanie JuanJohnson & Johnson, Titusville, New Jersey, USA.
Chandrasekhar Rao Venkata DamarajuJohnson & Johnson, Titusville, New Jersey, USA.
Dereck WentworthJohnson & Johnson, Titusville, New Jersey, USA.
Kevin WildenhausJohnson & Johnson, Titusville, New Jersey, USA.
Mithun PatelApple Inc, Cupertino, California, USA.
Cammie TavakoliApple Inc, Cupertino, California, 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.
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.
Heartline Steering Committee

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDigital health technologies can potentially improve clinical research efficiency and increase participant diversity but have challenges with long-term participant engagement.

objectivesThe Heartline Study evaluated the impact of a mobile app-based heart health engagement program with the Irregular Rhythm Notification (IRN) and electrocardiogram features of the Apple Watch on diagnosis, treatment, and outcomes of atrial fibrillation in U.S. participants aged ≥65 years.

methodsParticipants were randomized 3:1 to the watch group (vs no watch control group), stratified by prevalent atrial fibrillation. Participants interfaced with the study via a custom, app-based engagement program designed to facilitate participant enrollment, post-IRN follow-up, and electronic patient-reported outcome (ePRO) collection. To ensure users would respond to app-based reminders to complete ePROs and follow-up with providers after a potential IRN, targeted engagement strategies based on behavioral science principles were incorporated, including human-centered design, curated health education, and points-based incentives.

resultsOf 34,244 enrolled Heartline participants, 32,299 (94%) started the program. High, longitudinal participant engagement was seen, with 93% actively engaged with the app at least weekly after 1 year, and 86% after 2 years. ePRO completion rates were 82% at 1 year and 76% at 2 years. Upon study completion, participants reported high satisfaction with the study and their personal investment.

conclusionsStudy adherence in Heartline was high and sustained through 2-year follow-up, using a purposely designed engagement program delivered by a mobile app. Participants in this older population remotely and regularly submitted study information through the app and reported high study satisfaction (A Study to Investigate if Early Atrial Fibrillation [AF] Diagnosis Reduces Risk of Events Like Stroke in the Real-World; NCT04276441).

Indexed as

atrial fibrillationdecentralized direct-to-patient clinical studylong term retentionmobile health (mHealth)patient engagement

Identifiers

PMID40839901
PMCPMC12539446

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.