Village-doctor–led telehealth care to improve outcomes for AF and HF in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This cluster-randomized trial tests a telemedicine-supported, village doctor–led integrated care model for adults 65–80 with atrial fibrillation and heart failure in rural China. The model emphasizes ABC pathway-based management, regular follow-up, medication review, risk monitoring, guideline-directed therapy, timely specialist input, and structured patient education. Phase 1 assesses HF risk scores at 12 months, while Phase 2 looks at a composite cardiovascular endpoint over 36 months, with an observational follow-up at year 6. The study aims to determine if decentralized, primary-care–driven care can reduce adverse cardiovascular events and improve guideline-concordant treatment in a resource-limited rural setting.

Why it matters

Who can join: the full rules

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) Electrocardiogram (ECG) confirmation of AF or possession of a diagnostic certificate for AF issued by a specialist. 3) A documented history of HF, or newly diagnosed HF according to the 2026 ESC Guidelines for the management of heart failure. HF will require current or prior typical symptoms and/or signs attributable to a structural and/or functional cardiac abnormality. Participants with LVEF \<50% will be classified as having heart failure with reduced ejection fraction (HFrEF). In participants with LVEF ≥50%, heart failure with preserved ejection fraction (HFpEF) will require objective evidence of cardiac structural and/or functional abnormalities consistent with left ventricular diastolic dysfunction or elevated filling pressures, supported by elevated natriuretic peptide levels. In participants with AF, supportive echocardiographic abnormalities will include left atrial volume index (LAVI) \>40 mL/m², E/e' \>15, pulmonary artery systolic pressure \>35 mmHg, or tricuspid regurgitation velocity \>2.8 m/s. 4) Management by a village clinic near the participant's place of residence. 5) Ability to understand the study procedures and provide written informed consent.

Exclusion Criteria:

1. Expected life expectancy of less than 12 months.
2. Severe renal insufficiency (Ccr \< 30ml/min) or ongoing dialysis treatment.
3. Cardiac insufficiency secondary to correctable causes, including hyperthyroid heart disease, anemic heart disease, or uncorrected congenital heart disease.
4. Indications for pacemaker implantation without having undergone implantation.
5. Chronic obstructive pulmonary disease (COPD) complicated by type II respiratory failure.
6. Special populations, including patients with mental illnesses.

Where it's running

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

Study contacts

• Study coordinator: Ming Chu
• Email: chuming@njmu.edu.cn
• Phone: 13814010410

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.