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

초록

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 patientswith AF. Methods: This open-label, multicenter randomized controlled trial (ADHERE-App [Self-Awareness of Drug Adherence toEdoxaban 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 heartrate at specific times. The control group received only standard, guideline-recommended care. The primary end point was edoxabanadherence, 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 median97.5%, IQR 92.8%-100% at 6 months, P=.15). However, the proportion of adequate medication adherence (>= 95%) was significantlyhigher 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 ofadequate medication adherence (>= 95%) at 6 months. Conclusions: There was no difference in edoxaban adherence between the groups. However, the proportion of adequatemedication adherence was higher in the intervention group, and the benefit of the smartphone app-based intervention on medicationadherence 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&search_page=LInternational Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2021-048777

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