Health Behavior Management Program for Patients With Coronary Heart Disease: A Clinical Study
Phase: NA
Conditions: Coronary Disease
Sponsor: The First Affiliated Hospital of Bengbu Medical University

Cover Page
Official Title of the Study:
Health Behavior Management Program for Patients with Coronary Heart
Disease: A Clinical Study
ClinicalTrials.gov Identifier (NCT Number):
Not yet assigned
Document Type:
Study Protocol and Statistical Analysis Plan
Date:
[December 30, 2025]

Study Protocol and Statistical Analysis
Plan
1. Study Overview and Objectives
1.1 Study Background and Rationale
Coronary heart disease (CHD) remains a leading cause of morbidity and mortality
worldwide. Despite advances in pharmacological and interventional treatments,
secondary prevention and long-term health behavior management remain suboptimal.
Patients with CHD often experience reduced exercise capacity, progression of frailty,
and impaired quality of life.
Health behavior management programs integrating exercise rehabilitation, lifestyle
modification, and self-management support have shown potential benefits. However,
existing management models are often fragmented, lack personalization, and
demonstrate limited sustainability and patient adherence.
This study aims to evaluate a comprehensive health behavior management program
for patients with CHD, focusing on exercise-based secondary prevention and
multimodal behavioral interventions, and to assess its clinical effectiveness, feasibility,
and applicability.
1.2 Study Objectives
The primary objectives of this study are:
1. To evaluate the effectiveness of a health behavior management program on
exercise rehabilitation outcomes, frailty progression, and quality of life in
patients with CHD.
2. To develop and validate a risk prediction model for frailty occurrence in
patients with CHD based on multiple risk factors.
3. To assess the feasibility, sustainability, and cost-effectiveness of a structured
CHD health behavior management model.
2. Study Design and Methods
2.1 Key Scientific and Technical Issues
This study addresses the following key issues:

1. Development of a multi-factor risk prediction model for frailty in patients with
CHD.
2. Formulation of a long-term, sustainable secondary prevention management
strategy centered on exercise rehabilitation.
3. Integration of digital health tools to support multimodal behavioral
interventions.
2.2 Research Plan and Study Phases
Phase 1: Assessment of Current Health Management Practices
A systematic evaluation of existing CHD health management models will be
conducted through literature review, field investigation, patient interviews, and expert
consultation. Baseline data on patient demographics, clinical characteristics, health
behaviors, and management practices will be collected to identify gaps and unmet
needs in current secondary prevention strategies.
Phase 2: Risk Factor Analysis and Model Development
Cross-sectional surveys, longitudinal follow-up data, and/or existing databases will be
used to analyze factors associated with frailty in patients with CHD. Statistical
methods such as factor analysis, cluster analysis, and multivariable modeling will be
applied to identify key risk factors and develop a frailty risk prediction model.
Phase 3: Development and Implementation of the Health Behavior Management
Program
Based on evidence synthesis and expert consensus, a structured health behavior
management program will be developed. The intervention will include modular
components such as:

Exercise and cardiac rehabilitation training

Relaxation and breathing exercises

Medication adherence support

Nutritional and lifestyle guidance
Digital delivery methods (e.g., mobile platforms, short videos, graphical materials)
will be used to enhance engagement and adherence. The program will be
implemented in a standardized CHD patient cohort, and outcomes will be
systematically evaluated.
Phase 4: Effectiveness Evaluation and Health Economic Analysis
Clinical outcomes, patient-reported outcomes, and health service utilization data will
be collected to assess intervention effectiveness. Health economic analyses will be

conducted to evaluate cost-effectiveness, feasibility, and scalability of the
management model.
3. Statistical Analysis Plan
3.1 General Principles
Statistical analyses will be conducted using appropriate statistical software. All
analyses will follow predefined analysis plans. Descriptive statistics will summarize
baseline characteristics. Continuous variables will be expressed as mean ± standard
deviation or median (interquartile range), and categorical variables as frequencies and
percentages.
3.2 Effectiveness Analysis
Comparative analyses will be performed to evaluate changes in exercise capacity,
frailty status, and quality of life before and after intervention, and/or between study
groups if applicable. Appropriate parametric or non-parametric tests will be used
based on data distribution.
3.3 Risk Prediction Model Development
Multivariable regression models will be used to identify independent predictors of
frailty. Model performance will be evaluated using discrimination and calibration
metrics. Internal validation methods will be applied where appropriate.
3.4 Economic Evaluation
Cost-benefit and cost-effectiveness analyses will be conducted to assess the economic
impact of the intervention from a healthcare system perspective.
4. Implementation and Dissemination
If the intervention demonstrates feasibility and effectiveness, implementation
strategies based on implementation science frameworks will be applied to facilitate
translation into routine clinical practice. Dissemination will include academic
publications, conference presentations, and collaboration with healthcare stakeholders
to support broader adoption.