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NCT Number: NCT07799376

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location contact

Department of Cardiology, Nanfang Hospital

CONTACT

[email protected]

020-62707277

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Emergency department visit rate for cardiac-related reasons

    Time frame: 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.

  3. Social Support Rating Scale (SSRS) score

    Time frame: 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.

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

    Time frame: 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.

  5. Cardiovascular re-hospitalization rate

    Time frame: 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.

  6. Medication Adherence Report Scale (MARS-10) score

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Department of Cardiology, Nanfang Hospital

CONTACT

[email protected]

020-62707277

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

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

Acronym: ACS

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 2, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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