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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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." |
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| Control group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise rehabilitation plan and health management model for patients with coronary heart disease and frailty based on mobile health technology | Behavioral | 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". |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Frailty | The FRAIL Scale | 1month,3 months, 6 months |
| Grip strength | Electronic grip device | 1month,3 months, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tong Zhou | The First Affiliated Hospital of Bengbu Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical University | Bengbu | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 30, 2025 |
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| 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 |
| Dec 29, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 30, 2025 | Dec 29, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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