Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Aug 2, 2024
Date Accepted: Oct 9, 2024
Smartphone application for improving self-awareness of adherence to edoxaban treatment in atrial fibrillation (ADHERE-App trial): A randomized controlled trial
ABSTRACT
Background:
Adherence to oral anticoagulant therapy is essential to prevent stroke in patients with atrial fibrillation (AF).
Objective:
This study aimed to evaluate whether smartphone application-based interventions improve medication adherence in patients with AF.
Methods:
This randomized, open-label, multicenter trial enrolled patients with AF treated with edoxaban for stroke prevention. They were randomly assigned to application-conditioned feedback (intervention, n=248) and conventional treatment (control, n=250) groups. The intervention group daily received alerts via a smartphone application to take edoxaban and measure blood pressure and heart rate at specific times. The control group received only standard guideline-recommended care. The primary endpoint was edoxaban adherence, measured by pill count at 3 or 6 months. Medication adherence and 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 (98.0% [95.0%–100.0%] vs. 98.0% [91.0%–100.0%] for 3 months, P=.06; 98.0% [94.5%–100.0%] vs. 97.5% [92.8%–100.0%] for 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%, P=.01; 73.9% vs. 61.0%, 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 application-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 application may potentially improve medication adherence. Clinical Trial: International Clinical Trials Registry Platform KCT0004754
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