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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Village-Doctor Led Integrated Care
  1. 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. 2. Village doctors will provide AF management based on the ABC pathway and simplified home-based exercise rehabilitation education. 3. When clinical deterioration or management difficulties occur, village doctors may use a remote care platform to obtain cardiology specialist consult
• Другое 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.

Первичные конечные точки

• Change in Life's Essential 8 Cardiovascular Health Score [Срок оценки: Baseline to 12 months]
• Composite Cardiovascular Outcome [Срок оценки: Baseline to 36 months]
• Incidence of Asymptomatic Left Ventricular Dysfunction With or Without Heart Failure [Срок оценки: Baseline to 48 months]

Вторичные конечные точки (12)

• Cardiovascular Death [Срок оценки: 12 months after baseline]
• Cardiovascular Hospitalization [Срок оценки: 12 months after baseline]
• Emergency Visit for Cardiovascular Events [Срок оценки: 12 months after baseline]
• ischemic or hemorrhagic Stroke [Срок оценки: 12 months after baseline]
• The proportion of patients who met all the three criteria for the ABC pathway of integrated AF care [Срок оценки: 12 month after baseline]
• Cardiovascular Death [Срок оценки: 36 months after baseline]
• Ischemic or hemorrhagic Stroke [Срок оценки: 36 months after baseline]
• Worsening of heart failure or acute coronary syndrome [Срок оценки: 36 months after baseline]
• Emergency visit due to AF [Срок оценки: 36 months after baseline]
• All-cause mortality [Срок оценки: 36 months after baseline]
• The proportion of patients who met all the three criteria for the ABC pathway [Срок оценки: 36 month after baseline]
• Cardiovascular Death [Срок оценки: 48 months after baseline]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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).
• Expected survival of less than 12 months.
• Severe renal insufficiency, defined as creatinine clearance <30 mL/min, or currently receiving dialysis treatment.
• Cardiac dysfunction caused by reversible secondary causes, including hyperthyroid heart disease, anemic heart disease, or uncorrected congenital heart disease.
• Indication for pacemaker implantation but without pacemaker placement.
• Chronic obstructive pulmonary disease complicated by type II respiratory failure.
• Special populations, such as patients with mental illness.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

• Village Clinics in Dongtai City, Jiangsu Province — Yancheng
• Village Clinics in Jiangdu District, Jiangsu Province — Yangzhou
• Village Clinics in Suining County, Jiangsu Province — Xuzhou

Публикации

• 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. PMID 41817526
• 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. PMID 39984634
• 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. PMID 39553909

Идентификаторы

NCT: NCT07492498 · LSKY 2025-191-01，2026-SR-221

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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