跳至主要内容
临床试验/NCT07330882
NCT07330882Enrolling By Invitation不适用

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

The First Affiliated Hospital of Bengbu Medical University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年10月20日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
200
试验地点
1
主要终点
6MWD

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

6MWD

时间窗: 1month,3 months, 6 months

Measuring the maximum distance within 6 minutes.

The MOS item short from health survey

时间窗: 1month,3 months, 6 months

Quality of life was assessed using the 36-Item Short Form Health Survey questionnaire

次要结局

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

研究者

发起方
The First Affiliated Hospital of Bengbu Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhou,Tong

Associate Professor

The First Affiliated Hospital of Bengbu Medical University

研究点 (1)

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