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Telemedicine-based integrated management of atrial fibrillation in village clinics: a cluster randomized trial

Nature Medicine volume 31, pages 1276–1285 (2025) Cite this article

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Abstract

In rural China, where healthcare relies on village doctors (nonspecialized practitioners who work exclusively in their village clinics), delivering integrated atrial fibrillation (AF) management poses challenges. We developed a telemedicine-based, village doctor-led integrated care model and conducted a cluster randomized clinical trial to assess its efficacy compared to usual care. A total of 30 village clinics were randomly assigned (1:1) to the intervention or control group, with 1,039 village residents aged ≥65 years with AF (44.3% women) recruited. The primary outcome in stage 1 is adherence to integrated AF care at 12 months. In stage 2, the primary outcome is a composite of cardiovascular death, all strokes, heart failure or acute coronary syndrome hospitalization, and AF emergency visits over 36 months. Both primary outcomes were met. At 12 months, 33.1% in the telemedicine-based, village doctor-led care group and 8.7% in the usual care group met all criteria for integrated AF care (between-group difference, 24.4% (95% confidence interval (CI), 18.3–30.5%); P < 0.001). Over 34.0 months, 41.8% in the telemedicine-based, village doctor-led care group and 10.3% in the usual care group met all criteria for integrated AF care (P < 0.001). The rate of the composite cardiovascular event outcome was lower in the telemedicine-based, village doctor-led care group than in the usual care group (6.2% versus 9.6% per year; hazard ratio, 0.64 (95% CI, 0.50–0.82); P < 0.001). Our trial intervention by this telemedicine-based integrated care delivery model of AF care in rural villages demonstrates better adherence and improved clinical outcomes compared to usual care. ClinicalTrials.gov registration: NCT04622514.

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Fig. 1: Illustration of the MIRACLE-AF platform.
The alternative text for this image may have been generated using AI.
Fig. 2: Randomization and patient flow in the MIRACLE-AF trial.
The alternative text for this image may have been generated using AI.
Fig. 3: Cumulative incidence of the primary outcome in MIRACLE-AF stage 2.
The alternative text for this image may have been generated using AI.

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Data availability

Data supporting the findings of the MIRACLE-AF study are not publicly available due to patient privacy restrictions. However, patient-level data can be accessed upon request. To request access, please email the corresponding authors (M. Chen at chenminglong@njmu.edu.cn) with a detailed proposal for data use. Responses to requests will be provided within 2 months. If approved, access will be granted after the execution of a data access agreement, which will outline the terms and conditions of data use.

Code availability

No custom code or mathematical algorithm was used in the MIRACLE-AF study.

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Acknowledgements

We deeply appreciate W. Liu from the Department of Biostatistics, School of Public Health, Nanjing Medical University for statistical analysis. We acknowledge the invaluable contributions of our research teams at the First Affiliated Hospital of Nanjing Medical University and Jiangdu People’s Hospital, particularly X. Hua and T. Wu. Special thanks go to Y. Shen, J. Shi, C. Cai and all the graduate students for their contribution to data collection. We would like to express our gratitude to all the regional officers from the Jiangdu Health Commission (director: Z. Chen, vice directors: X. Liu and J. Sheng, and their colleagues) and the president of Jiangdu People’s Hospital (D. Lu). We also appreciate the Daqiao, Xiaoji, Yiling and Wuqiao township hospitals for their collaboration. This study was supported by the Key Clinical Study Project of Jiangsu Province, China (ID: BE2017750) and the Clinical Medicine Expert Team Project of Xuzhou, China (ID: 2019208002). M. Chen received these two grants. The funders had no role in study design, collection, enrollment, statistical analysis, interpretation of the data, decision to publish, or preparation or writing of the manuscript.

Author information

Author notes

  1. These authors contributed equally: Ming Chu, Shimeng Zhang, Jinlong Gong.

  2. These authors jointly supervised this work: Mingfang Li, Gregory Y. H. Lip, Minglong Chen.

Authors and Affiliations

  1. Division of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China

    Ming Chu, Shimeng Zhang, Shu Yang, Gang Yang, Xingxing Sun, Dan Wu, Yaodongqin Xia, Jincheng Jiao, Xiafeng Peng, Mingfang Li & Minglong Chen

  2. Division of Cardiology, Jiangdu People’s Hospital Affiliated to Yangzhou University, Yangzhou, China

    Jinlong Gong & Li Hong

  3. Department of Biostatistics, School of Public Health, Nanjing Medical University, Nanjing, China

    Zhihang Peng

  4. Division of Cardiology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China

    Zhirong Wang

  5. Liverpool Centre for Cardiovascular Science, University of Liverpool, Liverpool John Moores University and Liverpool Heart & Chest Hospital, Liverpool, UK

    Gregory Y. H. Lip

  6. Aalborg University, Aalborg, Denmark

    Gregory Y. H. Lip

  7. Chinese PLA General Hospital, Beijing, China

    Yutao Guo

  8. Jinling Hospital, Medical School of Nanjing University, Nanjing, China

    Xinfeng Liu

  9. Department of Radiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China

    Shanshan Lu

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Consortia

on behalf of the MIRACLE-AF Investigators

  • Minglong Chen
  • , Gregory Y. H. Lip
  • , Yutao Guo
  • , Xinfeng Liu
  •  & Shanshan Lu

Contributions

M. Chen, G.Y.H.L. and M.L. have full access to all data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. M. Chu, S.Z. and J.G. contributed equally to this study. Concept and design: M. Chen, M.L. and G.Y.H.L. Acquisition of data: all authors. Analysis and interpretation of data: M.L., M. Chu, S.Z., M. Chen and G.Y.H.L. Drafting of the paper: M. Chen, M.L., S.Z., S.Y., Y.X. and G.Y.H.L. Critical review of the paper for important intellectual content: all authors. Obtained funding: M. Chen. Administrative support: M. Chu, J.G. and M. Chen. Technical or material support: M.L., M. Chu, J.G. and M. Chen.

Corresponding authors

Correspondence to Mingfang Li, Gregory Y. H. Lip or Minglong Chen.

Ethics declarations

Competing interests

G.Y.H.L. is a consultant and speaker for BMS/Pfizer, Boehringer Ingelheim, Daiichi-Sankyo and Anthos. No fees are received personally. He is a National Institute for Health and Care Research (NIHR) senior investigator and co-principal investigator of the AFFIRMO project on multimorbidity in AF (grant agreement no. 899871), TARGET project on digital twins for personalized management of AF and stroke (grant agreement no. 101136244) and ARISTOTELES project on artificial intelligence for the management of chronic long-term conditions (grant agreement no. 101080189), which are all funded by the European Union’s Horizon Europe research and innovation program. The other authors declare no competing interests.

Peer review

Peer review information

Nature Medicine thanks Tze-Fan Chao, Emmanuel Ekanem, Zong-Chao Liu and the other, anonymous, reviewer(s) for their contribution to the peer review of this work. Primary Handling Editor: Ming Yang, in collaboration with the Nature Medicine team.

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Extended data

Extended Data Fig. 1 Sankey plot of the changes in ABC-compliant status from baseline to 12 months and 36 months with regard to the treatment strategy.

Panel A. Sankey plot of the changes in ABC-compliant status from baseline to 12 months and 36 months in the control group. Panel B. Sankey plot of the changes in ABC-compliant status from baseline to 12 months and 36 months in the intervention group.

Extended Data Fig. 2 Difference in the proportion of patients who met all three criteria for the ABC pathway at 12 months by subgroups.

The primary outcome at 12 months (stage 1) was the adherence to the integrated AF management, which was defined as fulfilment of all three ABC pathway criteria. It was analyzed using a generalized estimating equation (GEE) linear model with exchangeable correlation structure to estimating proportion difference with 95% confidence intervals (CIs) and P values at a two-sided significance level of 0.05. The size of the squares in the forest plot corresponds to the patient number in the analysis. ‘P values for interaction’ reflect the assessment of treatment heterogeneity by incorporating interaction terms between treatment and subgroup factors.

Extended Data Fig. 3 Primary Endpoint subgroup analysis over 36 months.

The primary outcome over 36 months (stage 2) was a composite of cardiovascular death, all strokes, including ischemic stroke and hemorrhagic stroke, hospitalization due to worsening of heart failure or acute coronary syndrome, and emergency visits due to atrial fibrillation over 36 months. The Cox proportional-hazards model was used to calculate HRs with 95% CIs for the primary composite endpoint at a two-sided significance level of 0.05. The middle line denotes an HR of 1.0, with error bars showing the 95% CIs. The size of the squares in the forest plot corresponds to the patient number in the analysis. ‘P values for interaction’ reflect the assessment of treatment heterogeneity by incorporating interaction terms between treatment and subgroup factors in the marginal Cox proportional hazards model. Abbreviations: CI, confidence interval; AF, atrial fibrillation.

Extended Data Table 1 Concomitant therapy of participating patients immediately after randomization
Full size table
Extended Data Table 2 Causes of death in the MIRACLE-AF trial
Full size table
Extended Data Table 3 Effectiveness of the village doctor-led telemedicine integrated care on outcomes at 12 months after multivariable analysis
Full size table
Extended Data Table 4 Primary and secondary outcomes in MIRACLE-AF Stage 2 after multivariable analysis
Full size table

Supplementary information

Supplementary Information (download PDF )

Supplementary Tables 1–3, Supplementary results, Supplementary Figs. 1–6, Supplementary protocol and Supplementary statistical analysis plan.

Reporting Summary (download PDF )

Supplementary Video 1 (download MP4 )

Guide to using the village doctor telemedicine platform—village doctor interface walkthrough.

Supplementary Video 2 (download MP4 )

Overview of the village doctor telemedicine platform—AF specialist interface walkthrough.

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Chu, M., Zhang, S., Gong, J. et al. Telemedicine-based integrated management of atrial fibrillation in village clinics: a cluster randomized trial. Nat Med 31, 1276–1285 (2025). https://doi.org/10.1038/s41591-025-03511-2

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