Acute Coronary Syndrome (ACS)ACSNCT07799376
Self-Management Support for Acute Coronary Syndrome Patients After Hospital Discharge
A study testing COM-B and HAPA-based Self-management Support Program and Routine Health Education in people with Acute Coronary Syndrome (ACS), run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome (ACS)
- What is being tested?
- COM-B and HAPA-based Self-management Support Program and Routine Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Department of Cardiology, Nanfang Hospital, 020-62707277, 243206095@qq.com
About this study
Official 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
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.
- Conditions
- Acute Coronary Syndrome (ACS)
- Being tested
- COM-B and HAPA-based Self-management Support Program, Routine Health Education
- Keywords
- Self-Management, Hospital-to-Home Transition, COM-B model, HAPA
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COM-B and HAPA-based Self-management Support ProgramBehavioural
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 EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants receive the structured self-management support program based on the integrated COM-B and HAPA models, including enhanced education and follow-up support. Receives: Behavioral: COM-B and HAPA-based Self-management Support Program |
| Control Group | Active comparator | Participants receive standard care and routine health education. Receives: Behavioral: Routine Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and at 13, 36, and 60 weeks of follow-up.
Secondary outcomes (6)
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.
Measured: From the end of treatment through 60 weeks of follow-up
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.
Measured: From the end of treatment through 60 weeks of follow-up
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.
Measured: At baseline and at 13, 36, and 60 weeks of follow-up
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.
Measured: At baseline and at 13, 36, and 60 weeks of follow-up
Cardiovascular re-hospitalization rate
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.
Measured: Assessed from the end of treatment through 60 weeks of follow-up.
Medication Adherence Report Scale (MARS-10) score
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.
Measured: Assessed at 13, 36, and 60 weeks of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary Syndrome (ACS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799376
- Sponsor's protocol ID
- NFEC-2026-428
- Other IDs
- 2025CR031
- Acronym
- ACS
- Status last verified
- Sep 2026
- First submitted
- 18 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Collet JP, Thiele H, Barbato E, Barthelemy O, Bauersachs J, Bhatt DL, Dendale P, Dorobantu M, Edvardsen T, Folliguet T, Gale CP, Gilard M, Jobs A, Juni P, Lambrinou E, Lewis BS, Mehilli J, Meliga E, Merkely B, Mueller C, Roffi M, Rutten FH, Sibbing D, Siontis GCM; ESC Scientific Document Group. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2021 Apr 7;42(14):1289-1367. doi: 10.1093/eurheartj/ehaa575. No abstract available.
PubMed 32860058