JMIR Publications

ABSTRACT

Background:

Atrial fibrillation (AF) is common in older people and increases stroke risk. The feasibility and effectiveness of implementation of a patient-led AF screening program for older people are unknown.

Objective:

This study aims to examine the feasibility and effectiveness of an AF screening program comprising patient-led monitoring of single-lead ECGs with clinician-coordinated central monitoring to diagnose AF among community-dwelling people aged ≥75 years in Australia.

Methods:

This is a nation-wide randomised controlled implementation trial, conducted virtually and remotely among 200 community-dwelling adults aged ≥75 years with no known AF. Randomisation will be in a 1:1 allocation ratio for intervention versus control. Intervention group participants will be enrolled in the monitoring program at randomisation. They will receive a handheld single-lead ECG device and training on self-recording of ECGs on weekdays and submitting their ECGs via their smartphone. Control group participants will receive usual care from their general practitioners (GPs) for the initial 6 months, then commence the 6-month monitoring program. ECGs will be reviewed centrally by trained personnel. Participants and their GPs will be notified of AF and other clinically significant ECG abnormalities.

Results:

This study will establish the feasibility and effectiveness of implementing the intervention in this patient population. The primary clinical outcome is AF detection rate, and the primary feasibility outcome is patient satisfaction score. Other outcomes include appropriate use of anticoagulant therapy, participant recruitment rate, program engagement (e.g., frequency of ECG transmission), agreement in ECG interpretation between the device automatic algorithm and clinicians, proportion of participants completed the trial and number of dropouts, and the impact of frailty on feasibility and clinical outcomes. We will conduct a qualitative evaluation to examine acceptability, barriers, and enablers to implementation.

Conclusions:

By incorporating an integrated healthcare approach involving patient empowerment, centralised clinician-coordinated ECG monitoring and facilitation of primary care and specialist services, it is possible to diagnose and treat AF early to reduce stroke risk. This study will provide new information on how to implement AF screening using digital health technology practicably and feasibly for older and frail populations residing in the community. Clinical Trial: Australian New Zealand Clinical Trials Registry (Registration number: ACTRN12621000184875)