Rurality and atrial fibrillation: A pathway to virtual engagement and clinical trial recruitment in response to COVID-19

Study objective To summarize trial adaptation from in-clinic to virtual design in response to the SARS-2 coronavirus-2 (COVID-19). Design A clinical trial of a mobile health intervention to improve chronic disease self-management for rural individuals with atrial fibrillation (AF). The trial has a 4-month intervention – accessible regardless of health or digital literacy – to enhance AF medication adherence and patient experience with 8- and 12-month assessments of sustainability. Setting Rural, western Pennsylvania. Participants Rural individuals with AF receiving oral anticoagulation for stroke prevention. Interventions Enrolled participants underwent a telephone-based orientation, provided verbal consent, and were randomized using a digital platform. They received a smartphone with intervention or control applications and a curriculum on usage tailored for study arm. Participants received study assessments by mail with telephone-based administration and contact for the 12-month trial. Main outcome measures Successful adaptation to virtual engagement and recruitment. Results The study enrolled 18 participants during in-clinic recruitment (January–March 2020). From 5/1/2020 to 5/6/2021 the study team enrolled 130 individuals (median age 72.4 years, range 40.8–92.2; 49.2% women, 63.1% without college degree, and 45.4% with limited health literacy). Retention of participants enrolled using virtual methods during the 4-month intervention phase is 92%. Conclusions We report a virtual trial of a mobile health intervention for rural individuals with AF. Our successful implementation suggests promise for engaging geographically isolated rural individuals, potential to enhance digital health access, and advance rural health equity.