Effect of a Home-Based Wearable Continuous ECG Monitoring Patch on Detection of Undiagnosed Atrial Fibrillation: The mSToPS Randomized Clinical Trial | Atrial Fibrillation | JAMA | JAMA Network
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This video summarizes findings from a combined randomized trial and matched cohort study testing the effects of immediate vs delayed use of a self-applied adhesive continuous ECG monitoring patch on new diagnoses of atrial fibrillation in patients at high risk of the dysrhythmia.

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Original Investigation
July 10, 2018

Effect of a Home-Based Wearable Continuous ECG Monitoring Patch on Detection of Undiagnosed Atrial Fibrillation: The mSToPS Randomized Clinical Trial

Author Affiliations
  • 1Scripps Translational Science Institute, La Jolla, California
  • 2Wave Research Center, La Jolla, California
  • 3Healthagen Outcomes, Chicago, Illinois
  • 4Janssen Scientific Affairs, Titusville, New Jersey
JAMA. 2018;320(2):146-155. doi:10.1001/jama.2018.8102
Key Points

Question  Can a home-based self-applied wearable electrocardiogram (ECG) patch improve the diagnosis of atrial fibrillation (AF) relative to routine care?

Findings  In this randomized clinical trial of 2659 individuals at increased risk for AF, immediate monitoring using a self-applied ECG patch, compared with delaying ECG monitoring for 4 months, led to a significantly higher rate of AF diagnosis at 4 months (3.9% vs 0.9%).

Meaning  Among individuals at increased risk for AF, use of a home-based self-applied ECG patch facilitated AF diagnosis; further research is needed regarding clinical implications.


Importance  Opportunistic screening for atrial fibrillation (AF) is recommended, and improved methods of early identification could allow for the initiation of appropriate therapies to prevent the adverse health outcomes associated with AF.

Objective  To determine the effect of a self-applied wearable electrocardiogram (ECG) patch in detecting AF and the clinical consequences associated with such a detection strategy.

Design, Setting, and Participants  A direct-to-participant randomized clinical trial and prospective matched observational cohort study were conducted among members of a large national health plan. Recruitment began November 17, 2015, and was completed on October 4, 2016, and 1-year claims-based follow-up concluded in January 2018. For the clinical trial, 2659 individuals were randomized to active home-based monitoring to start immediately or delayed by 4 months. For the observational study, 2 deidentified age-, sex- and CHA2DS2-VASc–matched controls were selected for each actively monitored individual.

Interventions  The actively monitored cohort wore a self-applied continuous ECG monitoring patch at home during routine activities for up to 4 weeks, initiated either immediately after enrolling (n = 1364) or delayed for 4 months after enrollment (n = 1291).

Main Outcomes and Measures  The primary end point was the incidence of a new diagnosis of AF at 4 months among those randomized to immediate monitoring vs delayed monitoring. A secondary end point was new AF diagnosis at 1 year in the combined actively monitored groups vs matched observational controls. Other outcomes included new prescriptions for anticoagulants and health care utilization (outpatient cardiology visits, primary care visits, or AF-related emergency department visits and hospitalizations) at 1 year.

Results  The randomized groups included 2659 participants (mean [SD] age, 72.4 [7.3] years; 38.6% women), of whom 1738 (65.4%) completed active monitoring. The observational study comprised 5214 (mean [SD] age, 73.7 [7.0] years; 40.5% women; median CHA2DS2-VASc score, 3.0), including 1738 actively monitored individuals from the randomized trial and 3476 matched controls. In the randomized study, new AF was identified by 4 months in 3.9% (53/1366) of the immediate group vs 0.9% (12/1293) in the delayed group (absolute difference, 3.0% [95% CI, 1.8%-4.1%]). At 1 year, AF was newly diagnosed in 109 monitored (6.7 per 100 person-years) and 81 unmonitored (2.6 per 100 person-years; difference, 4.1 [95% CI, 3.9-4.2]) individuals. Active monitoring was associated with increased initiation of anticoagulants (5.7 vs 3.7 per 100 person-years; difference, 2.0 [95% CI, 1.9-2.2]), outpatient cardiology visits (33.5 vs 26.0 per 100 person-years; difference, 7.5 [95% CI, 7.2-7.9), and primary care visits (83.5 vs 82.6 per 100 person-years; difference, 0.9 [95% CI, 0.4-1.5]). There was no difference in AF-related emergency department visits and hospitalizations (1.3 vs 1.4 per 100 person-years; difference, 0.1 [95% CI, −0.1 to 0]).

Conclusions and Relevance  Among individuals at high risk for AF, immediate monitoring with a home-based wearable ECG sensor patch, compared with delayed monitoring, resulted in a higher rate of AF diagnosis after 4 months. Monitored individuals, compared with nonmonitored controls, had higher rates of AF diagnosis, greater initiation of anticoagulants, but also increased health care resource utilization at 1 year.

Trial Registration  ClinicalTrials.gov Identifier: NCT02506244