The mobile health intervention for rural patients with atrial fibrillation a randomized controlled trial

BACKGROUND: Rural individuals with atrial fibrillation (AF) experience challenges to anticoagulation adherence and self-management of the condition. We tested an intervention to improve anticoagulation adherence, quality of life, and health care utilization in rural individuals with AF. METHODS: We randomized rural patients with AF receiving anticoagulation to receive a smartphone-based relational agent (for disease education and adherence guidance) and a heart rate and rhythm monitor for 4 months or a smartphone-based health education app. Adherence was determined with 12-month proportion of days covered (PDC), and secondary outcomes of quality of life and health care utilization from interviews and health records. RESULTS: The trial randomized 270 individuals 1:1 (median [IQR] age 73.1 [67.5-78.6]; 163 [60.4 %] female sex). Over the 4-month intervention, intervention participants used the relational agent a median of 101 (IQR: 72, 110) days. In an intention-to-treat analysis there was no significant difference in 12-month PDC between the intervention and control groups (median [IQR]: intervention 0.97 [0.89-1.00] versus control 0.97 [0.92-1.00]) or in PDC ≥0.80. Intervention participants were more likely to self-report anticoagulation adherence than control at 4 and 8 months (95.7 % vs 88.4 % and 93.0 % vs 78.8 %, respectively) but not at 12 months. There were no significant differences by assigned intervention for the other secondary outcomes. CONCLUSIONS: Randomization to the relational agent intervention was not associated with improved PDC at 12-months but with greater interim self-reported adherence compared to a control. This study demonstrates the successful use of a smartphone-based agent to address adherence among rural individuals with AF.