Self-Management Support for Acute Coronary Syndrome Patients After Hospital Discharge (ACS)
2026年9月2日 更新者：Nanfang Hospital, Southern Medical University
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
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.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
80
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Department of Cardiology, Nanfang Hospital
- 电话号码：020-62707277
- 邮箱：243206095@qq.com
学习地点
-
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Guangdong
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Guangzhou、Guangdong、中国、510515
- Nanfang Hospital, Southern Medical University
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接触：
- Department of Cardiology, Nanfang Hospital
- 电话号码：020-62707277
- 邮箱：243206095@qq.com
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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This intervention is based on the integrated HAPA and COM-B models.
Using HAPA, patients are categorized into three phases: pre-action (contemplation), action initiation (early post-discharge), and behavior maintenance (≥1 month post-discharge).
Prior to discharge, a COM-B assessment identifies individual barriers and facilitators across capability, opportunity, and motivation.
Tailored self-management support is then delivered according to the patient's phase and COM-B profile.
The core intervention consists of one in-depth inpatient interview and three outpatient sessions for self-management planning, execution, and confirmation.
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有源比较器：Control Group
Participants receive standard care and routine health education.
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Participants receive routine health education and standard care according to the hospital's standard clinical pathway for ACS patients.
This includes basic discharge instructions, brochures on heart-healthy lifestyles, and routine outpatient follow-up appointments.
No additional structured self-management support or extra telephone follow-ups are provided beyond standard care.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Heart Health Self-Efficacy and Self-Management Scale (HHSES) score
大体时间：At baseline and at 13, 36, and 60 weeks of follow-up.
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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.
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At baseline and at 13, 36, and 60 weeks of follow-up.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of major adverse cardiovascular events (MACE) including heart failure, angina, arrhythmia, and recurrent myocardial infarction
大体时间：From the end of treatment through 60 weeks of follow-up
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Major adverse cardiovascular events (MACE) is a composite outcome defined as the occurrence of heart failure, angina, arrhythmia, or recurrent myocardial infarction.
Reported as number and proportion of participants experiencing any component event and/or the composite MACE.
Assessed from the end of treatment through 60 weeks of follow-up.
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From the end of treatment through 60 weeks of follow-up
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Emergency department visit rate for cardiac-related reasons
大体时间：From the end of treatment through 60 weeks of follow-up
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Proportion of participants with emergency department visits for cardiac-related reasons during the follow-up period.
Calculated as (number of participants with cardiac-related emergency department visits ÷ total number of eligible participants at start of follow-up) × 100%.
Assessed from the end of treatment through 60 weeks of follow-up.
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From the end of treatment through 60 weeks of follow-up
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Social Support Rating Scale (SSRS) score
大体时间：At baseline and at 13, 36, and 60 weeks of follow-up
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The Social Support Rating Scale (SSRS) is a 10-item instrument assessing social support along three dimensions: objective support, subjective support, and utilization of social support.
Total scores range from 13 to 70.
Scores < 33 indicate low social support; 33-45 indicate moderate social support; and > 45 indicate high social support.
Assessed at baseline and at 13, 36, and 60 weeks of follow-up.
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At baseline and at 13, 36, and 60 weeks of follow-up
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Chinese Version of the Brief Illness Perception Questionnaire (BIPQ) score
大体时间：At baseline and at 13, 36, and 60 weeks of follow-up
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The Chinese Version of the Brief Illness Perception Questionnaire (BIPQ) is a 9-item instrument measuring illness perception.
Total scores range from 0 (minimum) to 80 (maximum), with higher scores indicating worse/more negative illness perception (stronger perceived threat or more negative views toward the illness).
Assessed at baseline and at 13, 36, and 60 weeks of follow-up.
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At baseline and at 13, 36, and 60 weeks of follow-up
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Cardiovascular re-hospitalization rate
大体时间：Assessed from the end of treatment through 60 weeks of follow-up.
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Proportion of participants re-hospitalized for cardiovascular reasons (e.g., heart failure, angina, arrhythmia, recurrent myocardial infarction) during the 12-month period after the end of treatment.
Calculated as (number of participants re-hospitalized for ACS-related cardiovascular reasons during the follow-up period ÷ total number of eligible patients at the start of the follow-up period) × 100%.
Assessed from the end of treatment through 60 weeks of follow-up.
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Assessed from the end of treatment through 60 weeks of follow-up.
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Medication Adherence Report Scale (MARS-10) score
大体时间：Assessed at 13, 36, and 60 weeks of follow-up.
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The Medication Adherence Report Scale (MARS-10) is a 10-item self-report questionnaire using a dichotomous yes/no response format.
It evaluates medication adherence across three dimensions: medication adherence behavior, attitude toward taking medication, and negative side effects and attitudes toward medication.
Total scores range from 0 to 10.
A score ≤ 5 indicates medication non-adherence, and a score ≥ 6 indicates medication adherence.
Assessed at 13, 36, and 60 weeks of follow-up.
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Assessed at 13, 36, and 60 weeks of follow-up.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2027年12月1日
研究完成 (估计的)
2028年12月1日
研究注册日期
首次提交
2026年8月18日
首先提交符合 QC 标准的
2026年8月30日
首次发布 (实际的)
2026年9月2日
研究记录更新
最后更新发布 (实际的)
2026年9月4日
上次提交的符合 QC 标准的更新
2026年9月2日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他研究编号
- NFEC-2026-428
- 2025CR031 (其他赠款/资助编号：2025 Nanfang Hospital of South)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
De-identified individual participant data (IPD) including baseline characteristics, intervention implementation data, and primary and secondary outcome measures will be shared.
The data sharing plan has been approved by the institutional ethics committee and included in the informed consent process.
IPD 共享时间框架
Data will be available starting from 6 months after the publication of the main results and will remain accessible for a period of 3 years.
IPD 共享访问标准
Access will be granted to qualified researchers (clinicians and nursing scientists) who propose to use the data for legitimate scientific purposes.
Interested researchers can submit a data request to the Principal Investigator via email.
A data use agreement must be signed prior to data access.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.