Acute Coronary Syndrome (ACS)
Conditions
Keywords
Self-Management, Hospital-to-Home Transition, COM-B model, HAPA
Brief summary
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.
Interventions
BEHAVIORALCOM-B and HAPA-based Self-management Support Program
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.
BEHAVIORALRoutine Health Education
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.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Due to the nature of the behavioral intervention, participants and care providers cannot be masked.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart Health Self-Efficacy and Self-Management Scale (HHSES) score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Emergency department visit rate for cardiac-related reasons | From the end of treatment through 60 weeks of follow-up | 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. |
| Social Support Rating Scale (SSRS) score | At baseline and at 13, 36, and 60 weeks of follow-up | 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. |
| Chinese Version of the Brief Illness Perception Questionnaire (BIPQ) score | At baseline and at 13, 36, and 60 weeks of follow-up | 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. |
| Cardiovascular re-hospitalization rate | Assessed from the end of treatment through 60 weeks of follow-up. | 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. |
| Medication Adherence Report Scale (MARS-10) score | Assessed at 13, 36, and 60 weeks of follow-up. | 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. |
Countries
China
Contacts
CONTACTDepartment of Cardiology, Nanfang Hospital
Outcome results
None listed