Evidence map›Paper›PMID 35234659›Full record

ArticleBMJ open2021

Heart Watch Study: protocol for a pragmatic randomised controlled trial.

Sanket S Dhruva, Nilay D Shah, Sreekanth Vemulapalli, Abhishek Deshmukh, Alexis L Beatty, Ginger M Gamble, James V Freeman, James P Hummel, Jonathan P Piccini, Joseph G Akar and 7 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04468321 (Heart Watch Study), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 20% of its field
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.

NCT04468321 nacompletednot on this map

Heart Watch Study: a Pragmatic Randomized Controlled Trial

TypeinterventionalSponsorYale UniversityRan2021 to 2024Enrolled105ConditionsCardioversion, Atrial FibrillationArmsApple Watch, Withings Move
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Article
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 at 7 institutions in 1 country.

Sanket S DhruvaSection of Cardiology, San Francisco Veterans Affairs Medical Center, San Francisco, California, USA sanket.dhruva@ucsf.edu.ORCID 0000-0003-0674-2032
Nilay D ShahDepartment of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA.
Sreekanth VemulapalliDuke Clinical Research Institute, Durham, North Carolina, USA.
Abhishek DeshmukhDepartment of Cardiovascular Medicine, Mayo Clinic, Rochester, New York, USA.
Alexis L BeattyDepartment of Medicine, University of California, San Francisco School of Medicine, San Francisco, California, USA.
Ginger M GambleCenter for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, Connecticut, USA.ORCID 0000-0002-8912-7440
James V FreemanCenter for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, Connecticut, USA.
James P HummelSection of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA.
Jonathan P PicciniDuke Clinical Research Institute, Durham, North Carolina, USA.ORCID 0000-0003-0772-2404
Joseph G AkarSection of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA.
Keondae ErvinNational Evaluation System for health Technology Coordinating Center (NESTcc), Medical Device Innovation Consortium, Arlington, Virginia, USA.
Kristine L ArgesDuke Clinical Research Institute, Durham, North Carolina, USA.
Lindsay EmanuelDepartment of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA.
Peter A NoseworthyRobert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota, USA.
Tiffany HuCenter for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, Connecticut, USA.
Victoria BartlettYale School of Medicine, New Haven, Connecticut, USA.
Joseph S RossCenter for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, Connecticut, USA.
Yale New Haven Hospital · USClinical Research Institute · USYale University · USMayo Clinic · USMayo Clinic in Arizona · USSan Francisco VA Medical Center · USUniversity of California, San Francisco · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Short-Term Reserch Training: Students in Health SchoolsT35HL007649 · NHLBI · YALE UNIVERSITY · PI Sarwat I Chaudhry, Erica L Herzog · 1987 to 2026
$5.7M
Shared decision making for stroke prevention in atrial fibrillation (SDM4Afib)R01HL131535 · NHLBI · MAYO CLINIC ROCHESTER · PI MONTORI, VICTOR MANUEL · 2016 to 2020
$3.2M
UCSF Career Development Program in Implementation Research in Heart and Lung DiseasesK12HL138046 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI BIBBINS-DOMINGO, KIRSTEN, CATTAMANCHI, ADITHYA · 2017 to 2021
$2.9M
Leveraging Physician Networks to Improve Care and Outcomes for Low-Income PopulationsR01HL144644 · NHLBI · YALE UNIVERSITY · PI NDUMELE, CHIMA · 2019 to 2021
$1.6M
Diffusion of Clinical Evidence into Practice: Physician Networks, Delivery Organizations, and MarketsR56HL130496 · NHLBI · UNIVERSITY OF MINNESOTA · PI KARACA-MANDIC, PINAR · 2016 to 2016
$634k
AHRQ HHS R01 HS022882AHRQ HHS R01 HS025164AHRQ HHS R01 HS025402AHRQ HHS R03 HS025517AHRQ HHS U19 HS024075FDA HHS U01 FD005938FDA HHS U01 FD006292NCATS NIH HHS UL1 TR001863NHLBI NIH HHS K12 HL138046NHLBI NIH HHS R01 HL131535NHLBI NIH HHS R01 HL144644NHLBI NIH HHS R56 HL130496NHLBI NIH HHS T35 HL007649
6 · The paper itself

Abstract

introductionPersonal digital devices that provide health information, such as the Apple Watch, have developed an increasing array of cardiopulmonary tracking features which have received regulatory clearance and are directly marketed to consumers. Despite their widespread and increasing use, data about the impact of personal digital device use on patient-reported outcomes and healthcare utilisation are sparse. Among a population of patients with atrial fibrillation and/or atrial flutter undergoing cardioversion, our primary aim is to determine the impact of the heart rate measurement, irregular rhythm notification, and ECG features of the Apple Watch on quality of life and healthcare utilisation. METHODS AND ANALYSIS: We are conducting a prospective, open-label multicentre pragmatic randomised clinical trial, leveraging a unique patient-centred health data sharing platform for enrolment and follow-up. A total of 150 patients undergoing cardioversion for atrial fibrillation or atrial flutter will be randomised 1:1 to receive the Apple Watch Series 6 or Withings Move at the time of cardioversion. The primary outcome is the difference in the Atrial Fibrillation Effect on QualiTy-of-life global score at 6 months postcardioversion. Secondary outcomes include inpatient and outpatient healthcare utilisation. Additional secondary outcomes include a comparison of the Apple Watch ECG and pulse oximeter features with gold-standard data obtained in routine clinical care settings. ETHICS AND DISSEMINATION: The Institutional Review Boards at Yale University, Mayo Clinic, and Duke University Health System have approved the trial protocol. This trial will provide important data to policymakers, clinicians and patients about the impact of the heart rate, irregular rhythm notification, and ECG features of widely used personal digital devices on patient quality of life and healthcare utilisation. Findings will be disseminated to study participants, at professional society meetings and in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04468321.

Indexed as

Atrial FibrillationAtrial FlutterElectric CountershockHumansMulticenter Studies as TopicPragmatic Clinical Trials as TopicProspective StudiesQuality of LifeRandomized Controlled Trials as Topicadult cardiologypacing & electrophysiologytelemedicine

Identifiers

PMID35234659
PMCPMC8719216
OpenAlexW4206806559

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.