Construction and Empirical Study of a "Hospital-to-Home" Self-Management Support Model for ACS Patients Based on the Integrated COM-B and HAPA Models
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Heart Health Self-Efficacy and Self-Management Scale (HHSES) score
研究概览
简要总结
This randomized controlled trial evaluates a "Hospital-to-Home" self-management support model for Acute Coronary Syndrome (ACS) patients, which is based on the integrated COM-B and HAPA theories. Participants are randomly assigned to either an intervention group receiving a structured self-management program or a control group receiving standard education. The study compares self-management behaviors and health outcomes between the two groups to assess the model's effectiveness.
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
- None
盲法说明
Due to the nature of the behavioral intervention, participants and care providers cannot be masked.
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
- 否
入选标准
- •Diagnosed with acute coronary syndrome (ACS) according to the Guidelines for the Rapid Emergency Diagnosis and Treatment of Acute Coronary Syndrome (2019), based on electrocardiogram (ECG), serological tests, and symptomatology.
- •Age ≥ 18 years.
- •Mentally alert, with unimpaired communication skills, and adequate reading and expressive abilities.
- •Patient, or their primary caregiver, able to use the study communication tool (WeChat).
排除标准
- •Advanced or terminal stage of disease with expected survival less than 12 months.
- •Severe physical comorbidities (e.g., decompensated cardiac, hepatic, or renal function).
- •Motor dysfunction or mobility impairment.
- •Currently participating in or previously participated in a similar clinical study.
研究组 & 干预措施
Intervention Group
Participants receive the structured self-management support program based on the integrated COM-B and HAPA models, including enhanced education and follow-up support.
干预措施: COM-B and HAPA-based Self-management Support Program (Behavioral)
Control Group
Participants receive standard care and routine health education.
干预措施: Routine Health Education (Behavioral)
结局指标
主要结局
Heart Health Self-Efficacy and Self-Management Scale (HHSES) score
时间窗: At baseline and at 13, 36, and 60 weeks of follow-up.
The Heart Health Self-Efficacy and Self-Management Scale (HHSES) is a 12-item instrument assessing participants' self-efficacy and self-management behaviors. Total scores range from 12 (minimum) to 48 (maximum), with higher scores indicating better self-efficacy and self-management. Scores ≥36 indicate high self-efficacy and self-management; 25-35 indicate a moderate level; and ≤24 indicate a low level. Administered at baseline and at 13, 36, and 60 weeks of follow-up.
次要结局
- Incidence of major adverse cardiovascular events (MACE) including heart failure, angina, arrhythmia, and recurrent myocardial infarction(From the end of treatment through 60 weeks of follow-up)
- Emergency department visit rate for cardiac-related reasons(From the end of treatment through 60 weeks of follow-up)
- Social Support Rating Scale (SSRS) score(At baseline and at 13, 36, and 60 weeks of follow-up)
- Chinese Version of the Brief Illness Perception Questionnaire (BIPQ) score(At baseline and at 13, 36, and 60 weeks of follow-up)
- Cardiovascular re-hospitalization rate(Assessed from the end of treatment through 60 weeks of follow-up.)
- Medication Adherence Report Scale (MARS-10) score(Assessed at 13, 36, and 60 weeks of follow-up.)