Accuracy, Usability, and Adherence of Smartwatches for Atrial Fibrillation Detection in Older Adults After Stroke: Randomized Controlled Trial.

Background: Atrial fibrillation (AF) is a common cause of stroke, and timely diagnosis is critical for secondary prevention. Little is known about smartwatches for AF detection among stroke survivors. We aimed to examine accuracy, usability, and adherence to a smartwatch-based AF monitoring system designed by older stroke survivors and their caregivers.

Objective: This study aims to examine the feasibility of smartwatches for AF detection in older stroke survivors.

Methods: Pulsewatch is a randomized controlled trial (RCT) in which stroke survivors received either a smartwatch-smartphone dyad for AF detection (Pulsewatch system) plus an electrocardiogram patch or the patch alone for 14 days to assess the accuracy and usability of the system (phase 1). Participants were subsequently rerandomized to potentially 30 additional days of system use to examine adherence to watch wear (phase 2). Participants were aged 50 years or older, had survived an ischemic stroke, and had no major contraindications to oral anticoagulants. The accuracy for AF detection was determined by comparing it to cardiologist-overread electrocardiogram patch, and the usability was assessed with the System Usability Scale (SUS). Adherence was operationalized as daily watch wear time over the 30-day monitoring period.

Results: A total of 120 participants were enrolled (mean age 65 years; 50/120, 41% female; 106/120, 88% White). The Pulsewatch system demonstrated 92.9% (95% CI 85.3%-97.4%) accuracy for AF detection. Mean usability score was 65 out of 100, and on average, participants wore the watch for 21.2 (SD 8.3) of the 30 days.

Conclusions: Our findings demonstrate that a smartwatch system designed by and for stroke survivors is a viable option for long-term arrhythmia detection among older adults at risk for AF, though it may benefit from strategies to enhance adherence to watch wear.

Trial Registration: ClinicalTrials.gov NCT03761394; https://clinicaltrials.gov/study/NCT03761394.

International Registered Report Identifier (irrid): RR2-10.1016/j.cvdhj.2021.07.002.