Health Behavior Management Program for Patients With Coronary Heart Disease

Official title

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

Overview

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.

Interventions

• 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".

Primary outcome measures

• 6MWD [Time frame: 1month,3 months, 6 months]
• The MOS item short from health survey [Time frame: 1month,3 months, 6 months]

Secondary outcome measures (7)

• Frailty [Time frame: 1month,3 months, 6 months]
• Grip strength [Time frame: 1month,3 months, 6 months]
• Gait speed [Time frame: 1month,3 months, 6 months]
• Physical activity level [Time frame: 1month,3 months, 6 months]
• Systolic pressure/Diastolic pressure [Time frame: 1month,3 months, 6 months]
• Major cardiovascular adverse events [Time frame: 1month,3 months, 6 months]
• Changes in Blood Lipid Biomarkers [Time frame: 1 month, 3 months, 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

China · 1 center

• The First Affiliated Hospital of Bengbu Medical University — Bengbu

Identifiers

NCT: NCT07330882 · FirstAHBBMC

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗