Mobile Health (mHealth) technology for improved screening, patient involvement and optimising integrated care in atrial fibrillation: The mAFA (mAF‐App) II randomised trial

BACKGROUND: Current management of patients with atrial fibrillation (AF) is limited by low detection of AF, nonadherence to guidelines and lack of consideration of patient's preferences, thus highlighting the need for a holistic and integrated approach to AF management. The present study aims to determine whether a mHealth technology-supported AF integrated management strategy will reduce AF-related adverse events.METHODS/DESIGN: The mAFA II trial is a prospective, cluster randomized controlled trial. The 40 sites will be randomized to mAFA-integrated care intervention or usual care arms. Prior to randomization, study sites will be paired to be matched in size and the proportion of study eligible patients. All AF patients aged over 18 years old with CHA2 DS2 -VASc score ≥2 will be enrolled. Assuming a composite adverse event rate of 10% pre-intervention, reduced to 5% after intervention, we aim to recruit 3660 patients assuming a 10% loss to follow-up. The primary study endpoint is a composite of stroke/thromboembolism, all-cause death, and rehospitalization. Ancillary analyses would determine patient-related outcome measures, health economics and cost effectiveness, as well as an embedded qualitative study.DISCUSSION: The mAFA II trial will provide evidence for an integrated care approach to holistic AF care, supported by mobile health technology to improve screening, patient involvement and optimization of management. This article is protected by copyright. All rights reserved.