Novel Model of Integrated Care of Older Patients With Atrial Fibrillation to Prevent Heart Failure in Rural China
Recruiting · NCT07492498 · Interventional (participants receive a specific treatment) · Lead sponsor: Jiangsu Taizhou People's Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Usual CareVillage-Doctor Led Integrated Care
What this trial is about
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.
Who can take part
Age range
65 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- \. 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.
- Availability of an electrocardiogram confirming atrial fibrillation, or an official diagnosis certificate of atrial fibrillation issued by a specialist.
- Receiving healthcare management from a primary medical institution near the place of residence.
- Able to understand and sign the informed consent form.
Exclusion criteria
- 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.
Where it is running
6 locations listed.
- Village Clinics in Dongtai City, Jiangsu Province - Yancheng, Dongtai, China
- Village Clinics in Dongtai City, Jiangsu Province - Yancheng, Dongtai, China
- Village Clinics in Jiangdu District, Jiangsu Province - Yangzhou, Jiangdu, China
- Village Clinics in Jiangdu District, Jiangsu Province - Yangzhou, Jiangdu, China
- Village Clinics in Suining County, Jiangsu Province - Xuzhou, Suining, China
- Village Clinics in Suining County, Jiangsu Province - Xuzhou, Suining, China