Background: The prevalence of atrial fibrillation (AF) increases with age and can lead to stroke. Therefore, older adults may benefit the most from AF screening. However, older adult populations tend to lag more than younger groups in the adoption of, and comfort with, the use of mobile health (mHealth) apps. Furthermore, although mobile apps that can detect AF are available to the public, most are designed for intermittent AF detection and for younger users. No app designed for long-term AF monitoring has released detailed system design specifications that can handle large data collections, especially in this age group.

Objective: This study aimed to design an innovative smartwatch-based AF monitoring mHealth solution in collaboration with older adult participants and clinicians.

Methods: The Pulsewatch system is designed to link smartwatches and smartphone apps, a website for data verification, and user data organization on a cloud server. The smartwatch in the Pulsewatch system is designed to continuously monitor the pulse rate with embedded AF detection algorithms, and the smartphone in the Pulsewatch system is designed to serve as the data-transferring hub to the cloud storage server.

Results: We implemented the Pulsewatch system based on the functionality that patients and caregivers recommended. The user interfaces of the smartwatch and smartphone apps were specifically designed for older adults at risk for AF. We improved our Pulsewatch system based on feedback from focus groups consisting of patients with stroke and clinicians. The Pulsewatch system was used by the intervention group for up to 6 weeks in the 2 phases of our randomized clinical trial. At the conclusion of phase 1, 90 trial participants who had used the Pulsewatch app and smartwatch for 14 days completed a System Usability Scale to assess the usability of the Pulsewatch system; of 88 participants, 56 (64%) endorsed that the smartwatch app is "easy to use." For phases 1 and 2 of the study, we collected 9224.4 hours of smartwatch recordings from the participants. The longest recording streak in phase 2 was 21 days of consecutive recordings out of the 30 days of data collection.

Conclusions: This is one of the first studies to provide a detailed design for a smartphone-smartwatch dyad for ambulatory AF monitoring. In this paper, we report on the system's usability and opportunities to increase the acceptability of mHealth solutions among older patients with cognitive impairment.

Trial registration: ClinicalTrials.gov NCT03761394; https://www.clinicaltrials.gov/ct2/show/NCT03761394.

International registered report identifier (irrid): RR2-10.1016/j.cvdhj.2021.07.002.