Smartphone App for Improving Self-Awareness of Adherence to Edoxaban Treatment in Patients With Atrial Fibrillation (ADHERE-App Trial): Randomized Controlled Trial

BACKGROUND: Adherence to oral anticoagulant therapy is essential to prevent ischemic stroke in patients with atrial fibrillation (AF). OBJECTIVE: This study aimed to evaluate whether smartphone app-based interventions improve medication adherence in patients with AF. METHODS: This open-label, multicenter randomized controlled trial (ADHERE-App Self-Awareness of Drug Adherence to Edoxaban Using an Automatic App Feedback System study) enrolled patients with AF treated with edoxaban for stroke prevention. They were randomly assigned to app-conditioned feedback (intervention; n=248) and conventional treatment (control; n=250) groups. The intervention group received daily alerts via a smartphone app to take edoxaban and measure blood pressure and heart rate at specific times. The control group received only standard, guideline-recommended care. The primary end point was edoxaban adherence, measured by pill count at 3 or 6 months. Medication adherence and the proportion of adequate medication adherence, which was defined as ≥95% of continuous medication adherence, were evaluated. RESULTS: Medication adherence at 3 or 6 months was not significantly different between the intervention and control groups (median 98%, IQR 95%-100% vs median 98%, IQR 91%-100% at 3 months, P=. 06; median 98%, IQR 94. 5%-100% vs median 97. 5%, IQR 92. 8%-100% at 6 months, P=. 15). However, the proportion of adequate medication adherence (≥95%) was significantly higher in the intervention group at both time points (76. 8% vs 64. 7% at 3 months, P=. 01; 73. 9% vs 61% at 6 months, P=. 007). Among patients aged >65 years, the intervention group showed a higher medication adherence value and a higher proportion of adequate medication adherence (≥95%) at 6 months. CONCLUSIONS: There was no difference in edoxaban adherence between the groups. However, the proportion of adequate medication adherence was higher in the intervention group, and the benefit of the smartphone app-based intervention on medication adherence was more pronounced among older patients than among younger patients. Given the low adherence to oral anticoagulants, especially among older adults, using a smartphone app may potentially improve medication adherence. TRIAL REGISTRATION: International Clinical Trials Registry Platform KCT0004754; https: //cris. nih. go. kr/cris/search/detailSearch. do? seq=28496&searchₚage=L. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10. 1136/bmjopen-2021-048777.