Testing MD-Link, a Low-Cost Mobile Electrocardiography Monitoring Device, in Patients With Irregular Heartbeat: Protocol for a Cross-Sectional Study

BACKGROUND: Having mobile devices that provide patients with the ability to record and monitor the electrical activity of their heart enhances patient self-care and the early detection of irregular heartbeat (cardiac arrhythmia), yet few such devices exist in Vietnam. Challenges exist for introducing mobile electrocardiography (ECG) monitoring devices in Vietnam, including patient accessibility and affordability. A low-cost mobile ECG monitoring device designed and developed in Vietnam, which allows patients to easily measure their heart’s electrical activity and navigate recordings, may be a solution. OBJECTIVE: The aim of this project is to assess the usability of the MD-Link system, a newly developed mobile handheld 1-lead ECG device, in detecting patients with irregular heartbeat. We will compare its outputs to the standard printed outputs of a 12-lead electrocardiogram generated by the Nihon Kohden Cardiofax S Electrocardiograph Model ECG-1250K. METHODS: We will conduct a cross-sectional study in two stages, including the measurement of ECG signals of patients using the MD-Link and the Nihon Kohden Cardiofax S and analysis of the selected standard outputs collected from the ECG recordings of the MD-Link and the Nihon Kohden Cardiofax S. The MD-Link consists of (1) a mobile device (eg, a smartphone); (2) a lead wire with 2 disposable electrodes; and (3) an easy-to-use mobile app interface enabling the upload and accurate display of ECG recordings to patients and their clinicians. Our research team, consisting of members from Dartmouth College; the Institute of Health, Population and Development; Hanoi University of Science and Technology; and physicians and nurses from Thanh Chan Clinic, will assist in carrying out this project. RESULTS: We will proceed with a publication plan that includes a project report and, ultimately, articles for peer-reviewed journals. We also hope to disseminate our work at relevant conferences to provide more coverage and exposure to the MD-Link mobile device. Recruitment and data collection were completed in January 2018. Data analysis started in February 2018 and is ongoing. Results are expected mid-2019. CONCLUSIONS: At the end of this project, we will have developed and tested the MD-Link, a low-cost mobile ECG monitoring device, with some supportive comparisons to standard ECG devices commonly used in heart clinics or hospitals in Vietnam. Our long-term goal is for the MD-Link to be easily accessible, affordable, and to fit into a patient’s daily routine, thus improving the care and treatment of patients with cardiovascular diseases (CVDs). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/8762