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

Autor:	Dhruva SS; Section of Cardiology, San Francisco Veterans Affairs Medical Center, San Francisco, California, USA sanket.dhruva@ucsf.edu.; Department of Medicine, University of California, San Francisco School of Medicine, San Francisco, California, USA., Shah ND; Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA.; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota, USA., Vemulapalli S; Duke Clinical Research Institute, Durham, North Carolina, USA.; Division of Cardiology, Duke University Medical Center, Durham, North Carolina, USA., Deshmukh A; Department of Cardiovascular Medicine, Mayo Clinic, Rochester, New York, USA., Beatty AL; Department of Medicine, University of California, San Francisco School of Medicine, San Francisco, California, USA.; Department of Epidemiology and Biostatistics, University of California San Francisco School of Medicine, San Francisco, California, USA., Gamble GM; Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, Connecticut, USA., Freeman JV; Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, Connecticut, USA.; Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA., Hummel JP; Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA., Piccini JP; Duke Clinical Research Institute, Durham, North Carolina, USA.; Division of Cardiology, Duke University Medical Center, Durham, North Carolina, USA., Akar JG; Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA., Ervin K; National Evaluation System for health Technology Coordinating Center (NESTcc), Medical Device Innovation Consortium, Arlington, Virginia, USA., Arges KL; Duke Clinical Research Institute, Durham, North Carolina, USA.; Division of Cardiology, Duke University Medical Center, Durham, North Carolina, USA., Emanuel L; Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA.; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota, USA., Noseworthy PA; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota, USA.; Department of Cardiovascular Medicine, Mayo Clinic, Rochester, New York, USA., Hu T; Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, Connecticut, USA., Bartlett V; Yale School of Medicine, New Haven, Connecticut, USA., Ross JS; Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, Connecticut, USA.; Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2021 Dec 30; Vol. 11 (12), pp. e054550. Date of Electronic Publication: 2021 Dec 30.
DOI:	10.1136/bmjopen-2021-054550
Abstrakt:	Introduction: Personal 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. Competing Interests: Competing interests: SSD reports research funding from the National Heart, Lung, and Blood Institute (NHLBI, K12HL138046) of the National Institutes of Health (NIH), from the Medical Device Innovation Consortium (MDIC) as part of the National Evaluation System for health Technology Coordinating Center (NESTcc), Food and Drug Administration (FDA), Greenwall Foundation, and Arnold Ventures. NDS has received research support through Mayo Clinic from the FDA to establish the Yale–Mayo Clinic Center for Excellence in Regulatory Science and Innovation program (CERSI, U01FD005938), from the Centers of Medicare and Medicaid Innovation under the Transforming Clinical Practice Initiative, from the Agency for Healthcare Research and Quality (AHRQ, U19HS024075, R01HS025164, R01HS025402, R03HS025517), from the NHLBI of the NIH (R56HL130496, R01HL131535), from the National Science Foundation, and from the Patient Centered Outcomes Research Institute to develop a Clinical Data Research Network. SV reports receiving funding support from the American College of Cardiology, Society of Thoracic Surgeons, and the NIH (R01 and Small Business Innovation Research BIR), FDA (through NESTcc), Abbott and Boston Scientific. He reports serving as a consultant or on the Advisory Board of Janssen, HeartFlow, the American College of Physicians, and Boston Scientific. ALB reported former employment at Apple and holds stock in Apple Inc. JVF reported salary support from the American College of Cardiology National Cardiovascular Data Registry and the NHLBI and consulting/advisory board fees from Boston Scientific, Medtronic, and Biosense Webster. JPP reports receiving grants for clinical research from Abbott, American Heart Association, Association for the Advancement of Medical Instrumentation, Bayer, Boston Scientific, and Philips and serves as a consultant to Abbott, Abbvie, Ablacon, Altathera, ARCA Biopharma, Biotronik, Boston Scientific, Bristol Myers Squibb, LivaNova, Medtronic, Milestone, ElectroPhysiology Frontiers, Itamar, Pfizer, Sanofi, Philips, ResMed, and Up-to-Date. PAN receives research funding from NIH, including the NHLBI and the National Institute on Aging (NIA), AHRQ, FDA and the American Heart Association (AHA). He is a study investigator in an ablation trial sponsored by Medtronic. PAN and Mayo Clinic are involved in potential equity/royalty relationship with AliveCor. JSR received research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing, from the FDA to establish Yale-Mayo Clinic CERSI program (U01FD005938), MDIC as part of the NESTcc, AHRQ (R01HS022882), NHLBI of the NIH (R01HS025164, R01HL144644), and from the Laura and John Arnold Foundation to establish the Good Pharma Scorecard at Bioethics International and to establish the Collaboration for Research Integrity and Transparency (CRIT) at Yale; in addition, JSR is an expert witness at the request of Relator's attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc. (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu