The ReInforcement of adherence via self-monitoring app orchestrating biosignals and medication of RivaroXaban in patients with atrial fibrillation and co-morbidities: a study protocol for a randomized controlled trial (RIVOX-AF)

Frontiers in Cardiovascular Medicine

Cardiovascular Medicine

Ji-Hyun Kim¹  Cam-Hao Hua²  Sungyoung Lee²  Hyun-Jai Cho³  Byung-Su Yoo⁴  Seonhwa Lee⁵  Hyue Mee Kim⁶  Dong-Ju Choi⁷  Taeho Hur⁷  Minjae Yoon⁷  Jin Joo Park⁷  Chi Young Shim⁸ 

[1] Cardiovascular Center, Dongguk University Ilsan Hospital, Goyang, Republic of Korea;Department of Computer Science and Engineering, Kyung Hee University, Yongin, Republic of Korea;Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea;Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea;Division of Cardiology, Department of Internal Medicine, Cardiovascular Center, Keimyung University Dongsan Hospital, Daegu, Republic of Korea;Division of Cardiology, Department of Internal Medicine, Chung-Ang University Hospital, Seoul, Republic of Korea;Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea;Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea;

关键词: atrial fibrillation;    NOAC;    drug adherence;    mobile application;    mobile health;   

DOI  :  10.3389/fcvm.2023.1130216

 received in 2022-12-23, accepted in 2023-05-05,  发布年份 2023

来源: Frontiers

【 摘 要 】

BackgroundBecause of the short half-life of non-vitamin K antagonist oral anticoagulants (NOACs), consistent drug adherence is crucial to maintain the effect of anticoagulants for stroke prevention in atrial fibrillation (AF). Considering the low adherence to NOACs in practice, we developed a mobile health platform that provides an alert for drug intake, visual confirmation of drug administration, and a list of medication intake history. This study aims to evaluate whether this smartphone app-based intervention will increase drug adherence compared with usual care in patients with AF requiring NOACs in a large population.MethodsThis prospective, randomized, open-label, multicenter trial (RIVOX-AF study) will include a total of 1,042 patients (521 patients in the intervention group and 521 patients in the control group) from 13 tertiary hospitals in South Korea. Patients with AF aged ≥19 years with one or more comorbidities, including heart failure, myocardial infarction, stable angina, hypertension, or diabetes mellitus, will be included in this study. Participants will be randomly assigned to either the intervention group (MEDI-app) or the conventional treatment group in a 1:1 ratio using a web-based randomization service. The intervention group will use a smartphone app that includes an alarm for drug intake, visual confirmation of drug administration through a camera check, and presentation of a list of medication intake history. The primary endpoint is adherence to rivaroxaban by pill count measurements at 12 and 24 weeks. The key secondary endpoints are clinical composite endpoints, including systemic embolic events, stroke, major bleeding requiring transfusion or hospitalization, or death during the 24 weeks of follow-up.DiscussionThis randomized controlled trial will investigate the feasibility and efficacy of smartphone apps and mobile health platforms in improving adherence to NOACs.Trial registrationThe study design has been registered in ClinicalTrial.gov (NCT05557123).

【 授权许可】

Unknown   
© 2023 Yoon, Park, Hur, Hao, Shim, Yoo, Cho, Lee, Kim, Kim, Lee and Choi.