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Rationale design and efficacy of a smartphone application for improving self-awareness of adherence to edoxaban treatment: study protocol for a randomised controlled trial (adhere app)

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Author(s)
In-Cheol KimJi Hyun LeeDong-Ju ChoiSung-Ji ParkJu-Hee LeeSang Min ParkMina KimHack-Lyoung KimSunki LeeIn Jai KimSeonghoon ChoiJaehun BangBilal AliMusarrat HussainTaqdir AliSungyoung Lee
Keimyung Author(s)
Kim, In Cheol
Department
Dept. of Internal Medicine (내과학)
Journal Title
BMJ Open
Issued Date
2022
Volume
12
Issue
4
Abstract
Introduction:
High adherence to oral anticoagulants is essential for stroke prevention in patients with atrial fibrillation (AF). We developed a smartphone application (app) that pushes alarms for taking medication and measuring blood pressure (BP) and heart rate (HR) at certain times of the day. In addition to drug alarms, the habit of measuring one’s BP and HR may reinforce drug adherence by improving self-awareness of the disease. This pilot study aims to test the feasibility and efficacy of the smartphone app-based intervention for improving drug adherence in patients with AF.

Methods and analysis:
A total of 10 university hospitals in Korea will participate in this randomised control trial. Patients with AF, being treated with edoxaban for stroke prevention will be included in this study. Total of 500 patients will be included and the patients will be randomised to the conventional treatment group (250 patients) and the app conditional feedback group (250 patients). Patients in the app conditional feedback group will use the medication reminder app for medication and BP check alarms. The automatic BP machine will be linked to the smartphone via Bluetooth. The measured BP and HR will be updated automatically on the smartphone app. The primary endpoint is edoxaban adherence by pill count measurement at 3 and 6 months of follow-up. Secondary endpoints are clinical composite endpoints including stroke, systemic embolic event, major bleeding requiring hospitalisation or transfusion, or death during the 6 months. As of 24t November 2021, 80 patients were enrolled.

Ethics and dissemination:
This study was approved by the Seoul National University Bundang Hospital Institutional Review Board and will be conducted according to the principles of the Declaration of Helsinki. The study results will be published in a reputable journal.
Keimyung Author(s)(Kor)
김인철
Publisher
School of Medicine (의과대학)
Citation
In-Cheol Kim et al. (2022). Rationale design and efficacy of a smartphone application for improving self-awareness of adherence to edoxaban treatment: study protocol for a randomised controlled trial (adhere app). BMJ Open, 12(4), e048777. doi: 10.1136/bmjopen-2021-048777
Type
Article
ISSN
2044-6055
Source
https://bmjopen.bmj.com/content/12/4/e048777
DOI
10.1136/bmjopen-2021-048777
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/44300
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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