Novel Model of Integrated Care of Older Patients With Atrial Fibrillation to Prevent Heart Failure in Rural China

This cluster randomized study aims to compare village doctor-led integrated care versus usual care to improve cardiovascular health, atrial fibrillation management, self-management adherence, and heart failure prevention among older rural patients with atrial fibrillation in China.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Atrial Fibrillation
• Intervention / Treatment: Other: Village-Doctor Led Integrated Care; Other: Usual Care

Detailed Description

BACKGROUND Atrial fibrillation (AF) is common among older adults and is strongly associated with heart failure (HF), stroke, hospitalization, cardiovascular death, and all-cause mortality. AF and HF interact bidirectionally and may form a self-perpetuating cycle, particularly in older patients. Although the Atrial Fibrillation Better Care (ABC) pathway is recommended to improve the comprehensive management of AF, older adults with AF in rural China remain particularly vulnerable because of limited access to specialist care, inadequate HF screening and risk stratification, suboptimal implementation of guideline-recommended treatment, and insufficient continuity of follow-up. HF is one of the most common and clinically important complications of AF and is strongly associated with adverse prognosis. Therefore, AF management should extend beyond stroke prevention and incorporate earlier identification, prevention, and management of HF. China's rural primary healthcare system relies heavily on village doctors; however, village doctors often have limited clinical resources, standardized training, and access to specialist support, which may hinder the delivery of long-term integrated care for patients with AF who are at risk of developing HF. A telemedicine-supported, village-doctor-led integrated care model incorporating regular follow-up, medication review, cardiovascular risk monitoring, ABC pathway-based AF management, simplified exercise rehabilitation, timely specialist consultation, and structured patient education may therefore improve cardiovascular health and reduce the risk of incident HF in this population.

AIM OF THIS STUDY This cluster randomized study aims to compare village doctor-led integrated care versus usual care in improving cardiovascular health, guideline-based AF management, self-management adherence, clinical outcomes, and prevention of HF among older rural patients with AF in China.

DESIGN This study is a prospective, cluster randomized, open-label, parallel-group clinical trial conducted in rural China. The study aims to enroll older rural residents aged 65 to 80 years with documented AF and without a history or screening evidence of HF or asymptomatic left ventricular dysfunction at baseline. Village clinics in Jiangsu Province will be randomized in a 1:1 ratio to either the intervention group or the control group. Patients in the intervention group will receive telemedicine-supported, village doctor-led integrated care, including monthly follow-up, symptom assessment, vital-sign monitoring, medication adherence support, cardiovascular risk-factor management, ABC pathway-based AF care, simplified home-based exercise rehabilitation education, and remote cardiology consultation when needed. Village doctors will receive standardized training on stroke prevention and anticoagulation, symptom and rate/rhythm management, and management of cardiovascular risk factors and comorbidities. Patients in the control group will receive usual chronic disease management according to the National Basic Public Health Service requirements, including routine follow-up, general health education, medication documentation, and referral when clinically indicated. Follow-up will last up to 48 months. The primary outcome at 12 months is the change in Life's Essential 8 cardiovascular health score from baseline. The primary outcome at 36 months is a composite cardiovascular endpoint including cardiovascular death, ischemic or hemorrhagic stroke, hospitalization for worsening HF or acute coronary syndrome, and emergency department visits due to AF. The primary outcome at 48 months is the incidence of asymptomatic left ventricular dysfunction with or without HF.

• Study Type: Interventional
• Enrollment (Estimated): 1356
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ming Chu; Phone Number: 13814010410; Email: chuming@njmu.edu.cn

Study Locations

• China
  • Dongtai
    • Yancheng, Dongtai, China, 224200
      • Recruiting
      • Village Clinics in Dongtai City, Jiangsu Province
      • Contact: Cheng Wu; Phone Number: 18012515515; Email: wucheng1413@163.com
  • Jiangdu
    • Yangzhou, Jiangdu, China, 225267
      • Recruiting
      • Village Clinics in Jiangdu District, Jiangsu Province
      • Contact: Ming Chu; Phone Number: 13814010410; Email: chuming@njmu.edu.cn
  • Suining
    • Xuzhou, Suining, China, 221200
      • Recruiting
      • Village Clinics in Suining County, Jiangsu Province
      • Contact: Wensu Chen; Phone Number: 15050848274; Email: Chen.wensu@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The village clinics need to be willing and able to provide integrated care to their patients with atrial fibrillation; 2. The village doctors from one village clinic serves all AF patients from 3-5 nearby villages; 3. The village doctors are trained to have a fundamental understanding of telemedicine; 4. Patients are eligible for participation if 1)they aged 65-80 years.

2)Availability of an electrocardiogram confirming atrial fibrillation, or an official diagnosis certificate of atrial fibrillation issued by a specialist.

3)Receiving healthcare management from a primary medical institution near the place of residence.

4)Able to understand and sign the informed consent form.

Exclusion Criteria:

1. A definite history of heart failure, or confirmed cardiac dysfunction or heart failure based on echocardiography and/or NT-proBNP screening. Diagnostic criteria include typical heart failure symptoms or signs with reduced left ventricular ejection fraction (HFrEF, LVEF <40%), mildly reduced left ventricular ejection fraction (HFmrEF, LVEF 40-49%), or preserved left ventricular ejection fraction with elevated NT-proBNP and structural heart disease evidence (HFpEF, LVEF ≥50%, with at least one of the following: LAVI >40 mL/m², E/e' ≥15, or TRV >2.8 m/s).
2. Expected survival of less than 12 months.
3. Severe renal insufficiency, defined as creatinine clearance <30 mL/min, or currently receiving dialysis treatment.
4. Cardiac dysfunction caused by reversible secondary causes, including hyperthyroid heart disease, anemic heart disease, or uncorrected congenital heart disease.
5. Indication for pacemaker implantation but without pacemaker placement.
6. Chronic obstructive pulmonary disease complicated by type II respiratory failure.
7. Special populations, such as patients with mental illness.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; Participants in this arm will receive usual chronic disease management according to the National Basic Public Health Service requirements.	Other: Usual Care; Participants in the control group will receive usual chronic disease management according to the National Basic Public Health Service requirements. Usual care includes routine follow-up, general health education, medication registration, and standard referral procedures provided by local primary care providers. Participants will not receive the structured village-doctor led integrated care program.
Experimental: Intervention Group; The intervention group will receive a village doctor-led integrated management program supported by telemedicine, guideline-based training, and a simplified exercise-based cardiac rehabilitation component, aiming to prevent incident heart failure in elderly rural patients with atrial fibrillation who have preserved cardiac function.	Other: Village-Doctor Led Integrated Care; Village doctors will conduct monthly follow-up, including symptom assessment, vital-sign monitoring, medication adherence support, cardiovascular risk-factor management, health education, and referral when needed.; Village doctors will provide AF management based on the ABC pathway and simplified home-based exercise rehabilitation education.; When clinical deterioration or management difficulties occur, village doctors may use a remote care platform to obtain cardiology specialist consultation and treatment recommendations within 24 hours.; Village doctors will receive standardized training on AF management, anticoagulation, rate/rhythm control, and cardiovascular risk-factor management.; Patients will receive structured education on medication adherence, symptom monitoring, lifestyle modification, exercise rehabilitation, and recognition of warning signs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Cardiovascular Outcome	Composite cardiovascular endpoint, including cardiovascular death, ischemic or hemorrhagic stroke, hospitalization for worsening heart failure or acute coronary syndrome, and emergency visits due to atrial fibrillation.	Baseline to 36 months
Incidence of Asymptomatic Left Ventricular Dysfunction With or Without Heart Failure	Incidence of asymptomatic left ventricular dysfunction with or without heart failure, assessed by clinical evaluation, NT-proBNP, and echocardiographic evidence of cardiac dysfunction.	Baseline to 48 months
Change in Life's Essential 8 Cardiovascular Health Score	Mean change in Life's Essential 8 cardiovascular health score from baseline to 12 months. The score includes diet, physical activity, nicotine exposure, sleep health, body mass index, non-HDL cholesterol, blood glucose, and blood pressure.	Baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular Death	Cardiovascular death was defined as death attributable to myocardial infarction, heart failure, arrhythmia, cardiac perforation or tamponade, or other deaths of cardiac origin. Death caused by ischemic stroke, hemorrhagic stroke, peripheral embolism, and pulmonary embolism was also classified as cardiovascular death	12 months after baseline
Cardiovascular Hospitalization	Hospitalization due to cardiovascular or neurological diseases at township-level or higher hospitals, including heart failure, cardiac arrhythmia, acute coronary syndrome, hypertensive emergency or urgency, ischemic or hemorrhagic stroke, and transient ischemic attack.	12 months after baseline
Emergency Visit for Cardiovascular Events	Incidence of emergency visits for cardiovascular events, including exacerbation of heart failure or acute coronary syndrome.	12 months after baseline
ischemic or hemorrhagic Stroke	All strokes: ischemic or hemorrhagic Stroke	12 months after baseline
The proportion of patients who met all the three criteria for the ABC pathway of integrated AF care	The 'A' criterion referred to stroke prevention or anticoagulation. 'A criterion compliant' implies that either appropriate non-vitamin K antagonist oral anticoagulant (NOACs) use, or warfarin was used with a time in the therapeutic range (TTR) >65%. Patients who were not properly treated with OACs are considered as 'A non-compliant'. The 'B' criterion referred to better symptom control with patient-centered decisions on rate or rhythm control. Patients with an EHRA score of I or II are considered to have good control of AF symptoms ('B compliant'). On the contrary, those with an EHRA score of III or IV were defined as 'B non-compliant', which means their symptoms were insufficiently controlled. The 'C' criterion stands for optimal management of cardiovascular risk factors and other comorbidities. 'C criterion compliant' implies that all the considered risk factors and comorbidities were well controlled or optimally treated. Otherwise, patients were considered as 'C non-compliant'	12 month after baseline
Cardiovascular Death	Cardiovascular death was defined as death attributable to myocardial infarction, heart failure, arrhythmia, cardiac perforation or tamponade, or other deaths of cardiac origin. Death caused by ischemic stroke, hemorrhagic stroke, peripheral embolism, and pulmonary embolism was also classified as cardiovascular deathTime	36 months after baseline
Ischemic or hemorrhagic Stroke	All strokes: ischemic or hemorrhagic Stroke	36 months after baseline
Worsening of heart failure or acute coronary syndrome	A worsening of heart failure or acute coronary syndrome was defined as the need to be hospitalized or have an emergency visit in conjunction with these conditions	36 months after baseline
Emergency visit due to AF	Emergency visit due to AF	36 months after baseline
All-cause mortality	all-cause death	36 months after baseline
The proportion of patients who met all the three criteria for the ABC pathway	The 'A' criterion referred to stroke prevention or anticoagulation. 'A criterion compliant' implies that either appropriate non-vitamin K antagonist oral anticoagulant (NOACs) use, or warfarin was used with a time in the therapeutic range (TTR) >65%. Patients who were not properly treated with OACs are considered as 'A non-compliant'. The 'B' criterion referred to better symptom control with patient-centered decisions on rate or rhythm control. Patients with an EHRA score of I or II are considered to have good control of AF symptoms ('B compliant'). On the contrary, those with an EHRA score of III or IV were defined as 'B non-compliant', which means their symptoms were insufficiently controlled. The 'C' criterion stands for optimal management of cardiovascular risk factors and other comorbidities. 'C criterion compliant' implies that all the considered risk factors and comorbidities were well controlled or optimally treated. Otherwise, patients were considered as 'C non-compliant'	36 month after baseline
Cardiovascular Death	Cardiovascular death was defined as death attributable to myocardial infarction, heart failure, arrhythmia, cardiac perforation or tamponade, or other deaths of cardiac origin. Death caused by ischemic stroke, hemorrhagic stroke, peripheral embolism, and pulmonary embolism was also classified as cardiovascular deathTime	48 months after baseline
Ischemic or hemorrhagic Stroke	All strokes: ischemic or hemorrhagic Stroke	48 months after baseline
Worsening of heart failure or acute coronary syndrome	A worsening of heart failure or acute coronary syndrome was defined as the need to be hospitalized or have an emergency visit in conjunction with these conditions	48 months after baseline
Emergency visit due to AF	Emergency visit due to AF	48 months after baseline
All-cause mortality	all-cause death	48 months after baseline
The proportion of patients who met all the three criteria for the ABC pathway	The 'A' criterion referred to stroke prevention or anticoagulation. 'A criterion compliant' implies that either appropriate non-vitamin K antagonist oral anticoagulant (NOACs) use, or warfarin was used with a time in the therapeutic range (TTR) >65%. Patients who were not properly treated with OACs are considered as 'A non-compliant'. The 'B' criterion referred to better symptom control with patient-centered decisions on rate or rhythm control. Patients with an EHRA score of I or II are considered to have good control of AF symptoms ('B compliant'). On the contrary, those with an EHRA score of III or IV were defined as 'B non-compliant', which means their symptoms were insufficiently controlled. The 'C' criterion stands for optimal management of cardiovascular risk factors and other comorbidities. 'C criterion compliant' implies that all the considered risk factors and comorbidities were well controlled or optimally treated. Otherwise, patients were considered as 'C non-compliant'	48 month after baseline

Collaborators and Investigators

• Sponsor: Jiangsu Taizhou People's Hospital
• Collaborators: The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

General Publications

• Chu M, Zhang S, Gong J, Yang S, Yang G, Sun X, Wu D, Xia Y, Jiao J, Peng X, Peng Z, Hong L, Wang Z, Li M, Lip GYH, Chen M; MIRACLE-AF Investigators. Telemedicine-based integrated management of atrial fibrillation in village clinics: a cluster randomized trial. Nat Med. 2025 Apr;31(4):1276-1285. doi: 10.1038/s41591-025-03511-2. Epub 2025 Feb 21.
• Li M, Chu M, Shen Y, Zhang S, Yin X, Yang S, Lip GYH, Chen M; MIRACLE-AF Trial Investigators. A Novel Model of Integrated Care of Older Patients With Atrial Fibrillation in Rural China. JACC Asia. 2024 Jul 30;4(10):764-773. doi: 10.1016/j.jacasi.2024.07.006. eCollection 2024 Oct.
• Li M, Chen Y, Chu M, Zhang S, Yang S, Lip GYH, Chen M. Village Doctor-Led Telemedicine for Rural Patients Aged 75 Years and Older With AF: A Prespecified Secondary Analysis of the MIRACLE-AF Trial. JAMA Netw Open. 2026 Mar 2;9(3):e261385. doi: 10.1001/jamanetworkopen.2026.1385.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 19, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): July 28, 2026
• Last Update Submitted That Met QC Criteria: July 25, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Integrated Care; Primary Prevention; Telemedicine Integrated Care
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Heart Failure; Atrial Fibrillation
• Other Study ID Numbers: LSKY 2025-191-01，2026-SR-221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No