Self-Management Support for Acute Coronary Syndrome Patients After Hospital Discharge

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNanfang Hospital, Southern Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • COM-B and HAPA-based Self-management Support Program

    Behavioral

    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.

  • Routine Health Education

    Behavioral

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Heart Health Self-Efficacy and Self-Management Scale (HHSES) score

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.

Time frame
At baseline and at 13, 36, and 60 weeks of follow-up.

Secondary outcomes

1

Incidence of major adverse cardiovascular events (MACE) including heart failure, angina, arrhythmia, and recurrent myocardial infarction

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.

Time frame
From the end of treatment through 60 weeks of follow-up
2

Emergency department visit rate for cardiac-related reasons

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.

Time frame
From the end of treatment through 60 weeks of follow-up
3

Social Support Rating Scale (SSRS) score

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.

Time frame
At baseline and at 13, 36, and 60 weeks of follow-up
4

Chinese Version of the Brief Illness Perception Questionnaire (BIPQ) score

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.

Time frame
At baseline and at 13, 36, and 60 weeks of follow-up

Other outcomes

Sponsors and contacts

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