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

NCT07492524 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1227

Last updated 2026-03-25

No results posted yet for this study

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

Interventions

BEHAVIORAL

Digital Intelligent Integrated Management

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

OTHER

Conventional Management

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.

Sponsors & Collaborators

  • Jiangsu Taizhou People's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-25
Primary Completion
2029-04-01
Completion
2029-04-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07492524 on ClinicalTrials.gov