Telemedicine-based Integrated Management of Atrial Fibrillation and Heart Failure in Older Patients in Village Clinics

NCT07492524 | Not Yet Recruiting DMC

• 1 other identifier: LSKY 2025-192-01
• Study Type: interventional
• Target: 1,227
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this cluster-randomized clinical trial is to evaluate a telemedicine-based, village doctor-led integrated management program for older adults (aged 65-80 years) who have both atrial fibrillation (AF) and heart failure (HF) in rural clinics in China. It aims to answer whether the digitally-supported program improves heart failure prognosis, assessed by the MAGGIC score, at 12 months , and reduces the risk of composite endpoint events, such as cardiovascular death, stroke, or heart failure hospitalization, over 36 months compared to conventional routine care. In this study, village clinics will be randomly assigned to either the intervention group or the control group. Participants in the control group will receive conventional routine care and basic public health services , while participants in the intervention group will receive a comprehensive management program led by village doctors. This intervention includes optimized medication treatment guided by a digital health platform with remote expert support , as well as a structured multidimensional lifestyle intervention featuring peer-support group exercises, smart wearable device monitoring, and personalized health education.

Conditions

Atrial Fibrillation; Heart Failure

Outcome Measures

Primary Outcomes (2)

• Change in Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) Risk Score

  Risk stratification is performed using the MAGGIC risk score, a validated integer scoring system that integrates 13 key predictors: age, gender, NYHA classification, left ventricular ejection fraction (LVEF), smoking status, diabetes, COPD, heart failure diagnosed within the past 18 months, systolic blood pressure (SBP), body mass index (BMI), serum creatinine level, use of beta-blockers, and use of ACEI/ARB. The cumulative score ranges from 0 to 50. Higher scores indicate a higher risk of mortality and a worse prognosis.

  Baseline to 12 months

• Number of Participants Experiencing a Composite Cardiovascular Endpoint

  This is a composite endpoint tracking the first occurrence of any of the following events: cardiovascular death, ischemic or hemorrhagic stroke, hospitalization due to worsening heart failure (HF) or acute coronary syndrome (ACS), and emergency visits for atrial fibrillation (AF).

  Up to 36 months

Secondary Outcomes (9)

• Number of Participants with Cardiovascular Death at 12 Months

  Up to 12 months

• Number of Participants with Cardiovascular-Related Hospitalization at 12 Months

  Up to 12 months

• Number of Participants with Emergency Visits for Cardiovascular Events at 12 Months

  Up to 12 months

• Number of Participants with Stroke at 12 Months

  Up to 12 months

• Number of Participants with Cardiovascular Death at 36 Months

  Up to 36 months

Study Arms (2)

Digital Intelligent Integrated Management Group

EXPERIMENTAL

Participants receive village doctor-led integrated management supported by digital technology. This includes a digital health platform for intelligent decision-making, remote specialist support, and structured multidimensional lifestyle interventions (cardiac rehabilitation, smart wearable device monitoring, and personalized health education)

Behavioral: Digital Intelligent Integrated Management

Conventional Management Group

ACTIVE COMPARATOR

Participants receive standard diagnosis and treatment for common chronic diseases (hypertension, diabetes, and COPD) and Basic Public Health Services (BPHS) provided by primary care physicians according to national specifications.

Other: Conventional Management

Interventions

Digital Intelligent Integrated Management BEHAVIORAL

This multi-component intervention includes: 1. A digital chronic disease management system for AF screening and intelligent decision-making. 2. Structured multidimensional lifestyle intervention featuring monthly peer-support group cardiac rehabilitation (aerobic, resistance, and flexibility training). 3. Smart wearable device monitoring (HUAWEI Band 6) for heart rate and step counts. 4. Personalized health education delivered via digital articles and videos. 5. Integrated management services providing guideline-directed medical therapy (GDMT) for heart failure and the ABC pathway for AF

Digital Intelligent Integrated Management Group

Conventional Management OTHER

Participants in the control group receive standard diagnosis and treatment for common chronic diseases (hypertension, diabetes, and chronic obstructive pulmonary disease) and Basic Public Health Services (BPHS) provided by primary care physicians. The 14 government-provided BPHS items primarily include quarterly follow-up visits for patients with hypertension, diabetes, and COPD, an annual free physical examination for residents aged 65 years and older, and the distribution of health education materials.

Conventional Management Group

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Permanent residents with local household registration at the primary level in Jiangsu Province, aged 65-80 years.
• Electrocardiogram (ECG) confirmation of AF or possession of a diagnostic certificate for AF issued by a specialist.
• A documented history of HF or a diagnosis of HF based on echocardiography and/or NT-proBNP screening, defined by the presence of typical HF symptoms and/or signs, together with one of the following: 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 changes (HFpEF; LVEF ≥ 50%, meeting at least one of the following criteria: LAV 40 ml/m², E/e' ≥ 15, or TRV \> 2.8 m/s).
• Management by a village clinic near the participant's place of residence.
• Ability to understand the study procedures and provide written informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Jiangsu Taizhou People's Hospital: lead

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 25, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL