• Eur. J. Clin. Invest. · Sep 2023

    Randomized Controlled Trial

    Mobile health technology integrated care in atrial fibrillation patients with diabetes mellitus in China: A subgroup analysis of the mAFA-II cluster randomized clinical trial.

    • Yutao Guo, Bernadette Corica, Giulio Francesco Romiti, Marco Proietti, Hui Zhang, LipGregory Y HGYHDepartment of Pulmonary Vessel and Thrombotic Disease, Medical School of Chinese PLA, Chinese PLA General Hospital, Beijing, China.Liverpool Centre for Cardiovascular Sciences at University of Liverpool, Liverpool John Moores University a, and mAF-App II Trial Investigators.
    • Department of Pulmonary Vessel and Thrombotic Disease, Medical School of Chinese PLA, Chinese PLA General Hospital, Beijing, China.
    • Eur. J. Clin. Invest. 2023 Sep 1; 53 (9): e14031e14031.

    BackgroundThe Mobile Health Technology for Improved Screening and Optimized Integrated Care in AF (mAFA-II) prospective randomized trial showed the efficacy of a mobile health (mHealth) implemented 'Atrial fibrillation Better Care' (ABC) pathway for the integrated care management of patients with atrial fibrillation (AF). In this ancillary analysis, we evaluated the effect of mAFA intervention according to the history of diabetes mellitus (DM).MethodsThe mAFA-II trial enrolled 3324 AF patients across 40 centres in China, between June 2018 and August 2019. In this analysis, we assessed the interaction between history of DM and the effect of mAFA intervention on the risk of the primary composite outcome of stroke, thromboembolism, all-cause death and rehospitalizations. Results were expressed as adjusted hazard ratio (aHR) and 95% confidence intervals (95%CI). The effect of mAFA intervention on exploratory secondary outcomes was also assessed.ResultsOverall, 747 (22.5%) patients had DM (mean age: 72.7 ± 12.3, 39.6% females; 381 allocated to mAFA intervention). mAFA intervention was associated with a significant risk reduction for the primary composite outcome both in patients with and without DM (aHR [95%CI]: .36 [.18-.73] and .37 [.23-.61], respectively, p for interaction = .941). A significant interaction was found only for the composite of recurrent AF, heart failure and acute coronary syndromes (pint  =.025), with lower effect of mAFA intervention in patients with DM.ConclusionsA mHealth-technology implemented ABC pathway showed a consistent effect in reducing the risk of the primary composite outcome in AF patients with and without DM.Trial RegistrationWHO International Clinical Trials Registry Platform (ICTRP) Registration number: ChiCTR-OOC-17014138.© 2023 The Authors. European Journal of Clinical Investigation published by John Wiley & Sons Ltd on behalf of Stichting European Society for Clinical Investigation Journal Foundation.

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