The Atrial Fibrillation Health Literacy Information Technology Trial: Pilot Trial of a Mobile Health App for Atrial Fibrillation (Preprint)

BACKGROUND Atrial fibrillation (AF) is a common arrhythmia that adversely affects health-related quality of life (HRQoL). We conducted a pilot trial of individuals with AF using a smartphone to provide a relational agent as well as rhythm monitoring. We employed our pilot to measure acceptability and adherence and to assess its effectiveness in improving HRQoL and adherence. OBJECTIVE This study aims to measure acceptability and adherence and to assess its effectiveness to improve HRQoL and adherence. METHODS Participants were recruited from ambulatory clinics and randomized to a 30-day intervention or usual care. We collected baseline characteristics and conducted baseline and 30-day assessments of HRQoL using the Atrial Fibrillation Effect on Quality of Life (AFEQT) measure and self-reported adherence to anticoagulation. The intervention consisted of a smartphone-based relational agent, which simulates face-to-face counseling and delivered content on AF education, adherence, and symptom monitoring with prompted rhythm monitoring. We compared differences in AFEQT and adherence at 30 days, adjusted for baseline values. We quantified participants’ use and acceptability of the intervention. RESULTS A total of 120 participants were recruited and randomized (59 to control and 61 to intervention) to the pilot trial (mean age 72.1 years, SD 9.10; 62/120, 51.7% women). The control group had a 95% follow-up, and the intervention group had a 93% follow-up. The intervention group demonstrated significantly higher improvement in total AFEQT scores (adjusted mean difference 4.5; 95% CI 0.6-8.3; P=.03) and in daily activity (adjusted mean difference 7.1; 95% CI 1.8-12.4; P=.009) compared with the control between baseline and 30 days. The intervention group showed significantly improved self-reported adherence to anticoagulation therapy at 30 days (intervention 3.5%; control 23.2%; adjusted difference 16.6%; 95% CI 2.8%-30.4%; P<.001). Qualitative assessments of acceptability identified that participants found the relational agent useful, informative, and trustworthy. CONCLUSIONS Individuals randomized to a 30-day smartphone intervention with a relational agent and rhythm monitoring showed significant improvement in HRQoL and adherence. Participants had favorable acceptability of the intervention with both objective use and qualitative assessments of acceptability.