Health Behavior Management Program for Patients With Coronary Heart Disease

Health Behavior Management Program for Patients With Coronary Heart Disease: A Clinical Study

Coronary artery disease (CAD) is a major chronic condition severely impacting population health in China. Our previous cohort studies revealed a high comorbidity rate between CAD and frailty, suggesting their interrelated equivalence as clinical syndromes with shared risk factors. In recent years, pilot integrated health management initiatives in China have demonstrated promising outcomes, yet evidence remains scarce regarding patients with concurrent CAD and frailty-a critical gap needing urgent resolution to achieve the "Healthy China 2030" strategic goals.

Building on prior research, this project aims to systematically evaluate existing management models for patients with CAD and frailty, develop a tailored health management framework, and implement it in clinical settings through empirical studies. The model will be optimized according to regional and demographic variations, leveraging cardiac rehabilitation centers, exercise-based interventions, and internet-enabled technologies to enhance coordinated care. By improving exercise efficacy, mitigating frailty progression, and enhancing quality of life, this initiative seeks to establish a robust chronic disease management system. The findings will provide evidence for formulating regional health policy and insurance strategies in Anhui Province, ultimately improving standardized management rates for chronic diseases.

Study Overview

• Status: Enrolling by invitation
• Conditions: Coronary Disease
• Intervention / Treatment: Behavioral: Exercise rehabilitation plan and health management model for patients with coronary heart disease and frailty based on mobile health technology

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Bengbu, China
    • The First Affiliated Hospital of Bengbu Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of Coronary heart disease;
• Proficiency in smartphone use;
• Absence of visual, auditory, cognitive, or motor impairments.

Exclusion Criteria:

• Inability or unwillingness to provide informed consent;
• Physical or cognitive limitations preventing app operation;
• Inability to attend in-person follow-up visits;
• Concurrent severe comorbidities or malignancies, such as severe valvular heart disease, New York Heart Association class IV heart failure, severe aortic regurgitation, cancer, end-stage renal or liver disease;
• Any other condition that could potentially impede exercise participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; The intervention consists of two parts: Health management model: Establish a "hospital-home" full-process health management service chain based on mobile health. Firstly, cardiac specialist nurses conduct a comprehensive assessment of each patient's cardiac rehabilitation status and implement individualized interventions. The specific intervention procedures are: "Assess the patient's current condition and capabilities - Promote the patient's awareness of the current situation - Develop and revise the cardiac rehabilitation plan - Supervise the implementation of the cardiac rehabilitation plan."	Behavioral: Exercise rehabilitation plan and health management model for patients with coronary heart disease and frailty based on mobile health technology; The development, application and evaluation of an innovative health management model for patients with coronary heart disease and frailty based on the "cardiac rehabilitation center" framework, exercise rehabilitation, and new technologies such as "mobile health".
Active Comparator: Control group; During the patient's hospital stay and after discharge, cardiovascular internal medical staff provide them with routine medical,nursing services and health education. In terms of basic drug treatment, the principles of secondary prevention for coronary heart disease should be followed. Routine nursing care and health education were delivered through verbal instruction and the "317 Nursing Education Platform." They were also advised to maintain a healthy lifestyle and participate in appropriate physical activities.	Behavioral: Exercise rehabilitation plan and health management model for patients with coronary heart disease and frailty based on mobile health technology; The development, application and evaluation of an innovative health management model for patients with coronary heart disease and frailty based on the "cardiac rehabilitation center" framework, exercise rehabilitation, and new technologies such as "mobile health".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6MWD	Measuring the maximum distance within 6 minutes.	1month,3 months, 6 months
The MOS item short from health survey	Quality of life was assessed using the 36-Item Short Form Health Survey questionnaire	1month,3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frailty	The FRAIL Scale	1month,3 months, 6 months
Grip strength	Electronic grip device	1month,3 months, 6 months
Gait speed	Stopwatch	1month,3 months, 6 months
Physical activity level	The short version self-reported International Physical Activity Questionnaire.	1month,3 months, 6 months
Systolic pressure/Diastolic pressure	Calibrated electronic blood pressure monitor	1month,3 months, 6 months
Major cardiovascular adverse events	Major Adverse Cardiovascular Events (MACE) were defined as at least one of the following: heart failure, malignant arrhythmia, recurrent angina, recurrent myocardial infarction, cardiogenic shock, cardiac arrest, or sudden cardiac death.	1month,3 months, 6 months
Changes in Blood Lipid Biomarkers	Changes in blood lipid biomarkers, including triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C), were assessed.	1 month, 3 months, 6 months

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Bengbu Medical University
• Investigators: Principal Investigator: Tong Zhou, The First Affiliated Hospital of Bengbu Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: December 29, 2025
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Quality of life; Cardiac rehabilitation; Frailty; Myocardial Ischemia
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Pathological Conditions, Signs and Symptoms; Frailty; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: FirstAHBBMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No