Yutao Guo1, Deirdre A Lane2,3, Liming Wang4, Yundai Chen1, Gregory Y H Lip1,2,3. 1. Medical School of Chinese PLA, Department of Cardiology, Chinese PLA General Hospital, Beijing, China. 2. Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, UK. 3. Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. 4. The National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.
Abstract
BACKGROUND: Current management of patients with atrial fibrillation (AF) is limited by low detection of AF, non-adherence to guidelines and lack of consideration of patient's preferences, thus highlighting the need for a holistic and integrated approach to AF management. This 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 randomised controlled trial. The 40 sites will be randomised to mAFA-integrated care intervention or usual care arms. Prior to randomisation, 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 rehospitalisation. 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 optimisation of management.
RCT Entities:
BACKGROUND: Current management of patients with atrial fibrillation (AF) is limited by low detection of AF, non-adherence to guidelines and lack of consideration of patient's preferences, thus highlighting the need for a holistic and integrated approach to AF management. This 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 randomised controlled trial. The 40 sites will be randomised to mAFA-integrated care intervention or usual care arms. Prior to randomisation, study sites will be paired to be matched in size and the proportion of study eligible patients. All AFpatients 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 rehospitalisation. 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 optimisation of management.
Authors: Fatima Ali-Ahmed; Karen Pieper; Rebecca North; Larry A Allen; Paul S Chan; Michael D Ezekowitz; Gregg C Fonarow; James V Freeman; Alan S Go; Bernard J Gersh; Peter R Kowey; Kenneth W Mahaffey; Gerald V Naccarelli; Sean D Pokorney; James A Reiffel; Daniel E Singer; Benjamin A Steinberg; Eric D Peterson; Jonathan P Piccini; Emily C O'Brien Journal: Eur Heart J Qual Care Clin Outcomes Date: 2020-10-01
Authors: Nicholas R Jones; Clare J Taylor; F D Richard Hobbs; Louise Bowman; Barbara Casadei Journal: Eur Heart J Date: 2020-03-07 Impact factor: 29.983
Authors: Jakub Gumprecht; Gregory Y H Lip; Adam Sokal; Beata Średniawa; Katarzyna Mitręga; Jakub Stokwiszewski; Łukasz Wierucki; Aleksandra Rajca; Marcin Rutkowski; Tomasz Zdrojewski; Tomasz Grodzicki; Jarosław Kaźmierczak; Grzegorz Opolski; Zbigniew Kalarus Journal: Cardiovasc Diabetol Date: 2021-06-24 Impact factor: 9.951