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)
Hack-Lyoung Kim,
Mina Kim,
Dong-Ju Choi,
Ji Hyun Lee,
Sang Min Park,
Sung-Ji Park,
In-Cheol Kim,
Ju-Hee Lee,
Sunki Lee,
In Jai Kim,
Seonghoon Choi,
Jaehun Bang,
Bilal Ali,
Musarrat Hussain,
Taqdir Ali,
Sungyoung Lee
Affiliations
Hack-Lyoung Kim
6 Division of Cardiology, Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, Korea (the Republic of)
Mina Kim
Division of Cardiology, Korea University College of Medicine, Seoul, Korea
Dong-Ju Choi
Division of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
Ji Hyun Lee
Department of Radiology, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
Sang Min Park
Department of Cardiology, Chuncheon Sacred Heart Hospital, Hallym University, Chuncheon, Korea
Sung-Ji Park
Division of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
In-Cheol Kim
Division of Cardiology, Department of Internal Medicine, Keimyung University Dongsan Hospital,Keimyung University School of Medicine, Daegu, Korea
Ju-Hee Lee
Division of Cardiology, Department of Internal Medicine, Chungbuk National University College of Medicine, Cheongju, Korea
Sunki Lee
Division of Cardiology, Hallym University College of Medicine, Gyunggi-do, Korea
In Jai Kim
Department of Internal Medicine, Bundang CHA Medical Center, CHA University, Seongnam, Korea
Seonghoon Choi
Department of Internal Medicine, Hallym University College of Medicine, Seoul, Korea
Jaehun Bang
Department of Computer Science and Engineering, Kyung Hee University, Yongin, Korea
Bilal Ali
Department of Cardiology, University of Minnesota, Minneapolis, Minnesota, USA
Musarrat Hussain
Department of Computer Science and Engineering, Kyung Hee University, Yongin, Korea
Taqdir Ali
Department of Computer Science and Engineering, Kyung Hee University, Yongin, Korea
Sungyoung Lee
Department of Computer Science and Engineering, Kyung Hee University, Yongin, Korea
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.Trial registration number KCT0004754.
