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)

Minjae Yoon; Jin Joo Park; Taeho Hur; Cam-Hao Hua; Chi Young Shim; Byung-Su Yoo; Hyun-Jai Cho; Seonhwa Lee; Hyue Mee Kim; Ji-Hyun Kim; Sungyoung Lee; Dong-Ju Choi

doi:10.3389/fcvm.2023.1130216

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)

Front Cardiovasc Med. 2023 May 24:10:1130216. doi: 10.3389/fcvm.2023.1130216. eCollection 2023.

Authors

Minjae Yoon¹, Jin Joo Park¹, Taeho Hur¹, Cam-Hao Hua², Chi Young Shim³, Byung-Su Yoo⁴, Hyun-Jai Cho⁵, Seonhwa Lee⁶, Hyue Mee Kim⁷, Ji-Hyun Kim⁸, Sungyoung Lee², Dong-Ju Choi¹

Affiliations

¹ Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.
² Department of Computer Science and Engineering, Kyung Hee University, Yongin, Republic of Korea.
³ Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
⁴ Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea.
⁵ Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.
⁶ Division of Cardiology, Department of Internal Medicine, Cardiovascular Center, Keimyung University Dongsan Hospital, Daegu, Republic of Korea.
⁷ Division of Cardiology, Department of Internal Medicine, Chung-Ang University Hospital, Seoul, Republic of Korea.
⁸ Cardiovascular Center, Dongguk University Ilsan Hospital, Goyang, Republic of Korea.

Abstract

Background: Because 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.

Methods: This 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.

Discussion: This randomized controlled trial will investigate the feasibility and efficacy of smartphone apps and mobile health platforms in improving adherence to NOACs.

Trial registration: The study design has been registered in ClinicalTrial.gov (NCT05557123).

Keywords: NOAC; atrial fibrillation; drug adherence; mobile application; mobile health.

Associated data

ClinicalTrials.gov/NCT05557123

Grants and funding

This research was supported by a grant from Samjin Pharmaceuticals via the SNUBH (Seoul National University Bundang Hospital) 06-2021-0092 and an Institute of Information & communications Technology Planning & Evaluation (IITP) grant funded by the Korea government (2022-0-00078, Explainable Logical Reasoning for Medical Knowledge Generation) and the MSIT (Ministry of Science and ICT), Korea, under the Grand Information Technology Research Center support program (IITP-2022-2020-0-01489) supervised by the IITP.