Yutao Guo1, Deirdre A Lane2, Limin Wang3, Hui Zhang1, Hao Wang1, Wei Zhang4, Jing Wen5, Yunli Xing6, Fang Wu7, Yunlong Xia8, Tong Liu9, Fan Wu10, Zhaoguang Liang11, Fan Liu12, Yujie Zhao13, Rong Li14, Xin Li15, Lili Zhang16, Jun Guo1, Girvan Burnside17, Yundai Chen18, Gregory Y H Lip19. 1. Medical School of Chinese PLA, Department of Cardiology, Chinese PLA General Hospital, Beijing, China. 2. Liverpool Centre for Cardiovascular Sciences, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom, and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. 3. The National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China. 4. Department of Gerontology and Geriatric Medicine, Seventh Clinical Center, Chinese PLA General Hospital, Beijing, China. 5. Department of Geriatric Cardiology, Haidian Hospital, Beijing, China. 6. Beijing Friendship Hospital, Capital Medical University, Beijing, China. 7. Department of Gerontology and Geriatric Medicine, Ruijin Hospital Affiliated to School of Medicine, Shanghai Jiaotong University, Shanghai, China. 8. Department of Cardiology, First Affiliated Hospital of Dalian Medical University, Dalian, China. 9. Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China. 10. Department of Geriatrics, Tianjin Medical University General Hospital, Tianjin Geriatrics Institute, Tianjin, China. 11. Department of Cardiology, First Affiliated Hospital of Haerbing Medical University, Haerbing, China. 12. Department of Cardiology, Second Hospital of Hebei Medical University, Shijiazhuang, China. 13. Department of Cardiology, Henan Cardiovascular Hospital Affiliated to Southern Medical University, Henan, China. 14. Department of Cardiology, First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. 15. Department of Cardiology, Benq Medical Center, Nanjing Medical University, Nanjing, China. 16. Department of Cardiology, Longhua People's Hospital, Shenzhen, China. 17. Department of Biostatistics, University of Liverpool, Liverpool, United Kingdom. 18. Medical School of Chinese PLA, Department of Cardiology, Chinese PLA General Hospital, Beijing, China. Electronic address: cyundai@vip.163.com. 19. Medical School of Chinese PLA, Department of Cardiology, Chinese PLA General Hospital, Beijing, China; Liverpool Centre for Cardiovascular Sciences, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom, and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. Electronic address: gregory.lip@liverpool.ac.uk.
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 patients' preferences, thus highlighting the need for a more holistic and integrated approach to AF management. OBJECTIVE: The objective of this study was to determine whether a mobile health (mHealth) technology-supported AF integrated management strategy would reduce AF-related adverse events, compared with usual care. METHODS: This is a cluster randomized trial of patients with AF older than 18 years of age who were enrolled in 40 cities in China. Recruitment began on June 1, 2018 and follow-up ended on August 16, 2019. Patients with AF were randomized to receive usual care, or integrated care based on a mobile AF Application (mAFA) incorporating the ABC (Atrial Fibrillation Better Care) Pathway: A, Avoid stroke; B, Better symptom management; and C, Cardiovascular and other comorbidity risk reduction. The primary composite outcome was a composite of stroke/thromboembolism, all-cause death, and rehospitalization. Rehospitalization alone was a secondary outcome. Cardiovascular events were assessed using Cox proportional hazard modeling after adjusting for baseline risk. RESULTS: There were 1,646 patients allocated to mAFA intervention (mean age, 67.0 years; 38.0% female) with mean follow-up of 262 days, whereas 1,678 patients were allocated to usual care (mean age, 70.0 years; 38.0% female) with mean follow-up of 291 days. Rates of the composite outcome of 'ischemic stroke/systemic thromboembolism, death, and rehospitalization' were lower with the mAFA intervention compared with usual care (1.9% vs. 6.0%; hazard ratio [HR]: 0.39; 95% confidence interval [CI]: 0.22 to 0.67; p < 0.001). Rates of rehospitalization were lower with the mAFA intervention (1.2% vs. 4.5%; HR: 0.32; 95% CI: 0.17 to 0.60; p < 0.001). Subgroup analyses by sex, age, AF type, risk score, and comorbidities demonstrated consistently lower HRs for the composite outcome for patients receiving the mAFA intervention compared with usual care (all p < 0.05). CONCLUSIONS: An integrated care approach to holistic AF care, supported by mHealth technology, reduces the risks of rehospitalization and clinical adverse events. (Mobile Health [mHealth] technology integrating atrial fibrillation screening and ABC management approach trial; ChiCTR-OOC-17014138).
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 patients' preferences, thus highlighting the need for a more holistic and integrated approach to AF management. OBJECTIVE: The objective of this study was to determine whether a mobile health (mHealth) technology-supported AF integrated management strategy would reduce AF-related adverse events, compared with usual care. METHODS: This is a cluster randomized trial of patients with AF older than 18 years of age who were enrolled in 40 cities in China. Recruitment began on June 1, 2018 and follow-up ended on August 16, 2019. Patients with AF were randomized to receive usual care, or integrated care based on a mobile AF Application (mAFA) incorporating the ABC (Atrial Fibrillation Better Care) Pathway: A, Avoid stroke; B, Better symptom management; and C, Cardiovascular and other comorbidity risk reduction. The primary composite outcome was a composite of stroke/thromboembolism, all-cause death, and rehospitalization. Rehospitalization alone was a secondary outcome. Cardiovascular events were assessed using Cox proportional hazard modeling after adjusting for baseline risk. RESULTS: There were 1,646 patients allocated to mAFA intervention (mean age, 67.0 years; 38.0% female) with mean follow-up of 262 days, whereas 1,678 patients were allocated to usual care (mean age, 70.0 years; 38.0% female) with mean follow-up of 291 days. Rates of the composite outcome of 'ischemic stroke/systemic thromboembolism, death, and rehospitalization' were lower with the mAFA intervention compared with usual care (1.9% vs. 6.0%; hazard ratio [HR]: 0.39; 95% confidence interval [CI]: 0.22 to 0.67; p < 0.001). Rates of rehospitalization were lower with the mAFA intervention (1.2% vs. 4.5%; HR: 0.32; 95% CI: 0.17 to 0.60; p < 0.001). Subgroup analyses by sex, age, AF type, risk score, and comorbidities demonstrated consistently lower HRs for the composite outcome for patients receiving the mAFA intervention compared with usual care (all p < 0.05). CONCLUSIONS: An integrated care approach to holistic AF care, supported by mHealth technology, reduces the risks of rehospitalization and clinical adverse events. (Mobile Health [mHealth] technology integrating atrial fibrillation screening and ABC management approach trial; ChiCTR-OOC-17014138).
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