Design and rationale of the mobile health intervention for rural atrial fibrillation

Background Atrial fibrillation (AF) is a highly morbid condition which requires long-term adherence to oral anticoag-ulation and may be associated with adverse quality of life and health care utilization. We developed a relational agent-an interactive smartphone-based intervention accessible regardless of digital or health literacy-to assist individuals residing in rural, Western Pennsylvania, with AF with chronic disease self-management.Methods The Mobile health intervention for rural atrial fibrillation is a single center, parallel-arm randomized clinical trial for adults with AF funded by the National Institute of Health's National Heart, Lung, and Blood Institute to enroll 264 par ticipants. All par ticipants receive a smar tphone with data plan: The intervention is a 4 month relational agent coupled with the AliveCor Kardia for heart rate and rhythm monitoring provided by smartphone, and the control a pre-installed, smartphone-based application for health-related information (WebMD). The study uses remote recruitment and engagement to enroll individuals who would otherwise be unlikely to participate in clinical research due to rurality. The primary outcome of the trial is adherence to oral anticoagulation, determined by proportion of days covered, as measured at 12 months. The secondary outcomes are quality of life, both AF-specific and general, and health care utilization. The study entails a baseline visit, a 4 month intervention phase, and 8 and 12 month follow-up visits. Conclusions This mobile health trial tests the effectiveness of a smartphone-based relational agent to improve clinical and patient-reported outcomes in rural-dwelling individuals. (Am Heart J 2022;252:16-25.)

Automated summary

This study aims to test the efficacy of a smartphone-based relational agent in improving clinical and patient-reported outcomes in rural-dwelling individuals.