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

2 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

80

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Department of Cardiology, Nanfang Hospital
  • Telefoonnummer: 020-62707277
  • E-mail: 243206095@qq.com

Studie Locaties

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Nanfang Hospital, Southern Medical University
        • Contact:
          • Department of Cardiology, Nanfang Hospital
          • Telefoonnummer: 020-62707277
          • E-mail: 243206095@qq.com

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: COM-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.
Actieve vergelijker: Control Group
Participants receive standard care and routine health education.
Gedragsmatig: Routine 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Heart Health Self-Efficacy and Self-Management Scale (HHSES) score
Tijdsspanne: 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.
At baseline and at 13, 36, and 60 weeks of follow-up.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of major adverse cardiovascular events (MACE) including heart failure, angina, arrhythmia, and recurrent myocardial infarction
Tijdsspanne: 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.
From the end of treatment through 60 weeks of follow-up
Emergency department visit rate for cardiac-related reasons
Tijdsspanne: 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.
From the end of treatment through 60 weeks of follow-up
Social Support Rating Scale (SSRS) score
Tijdsspanne: 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.
At baseline and at 13, 36, and 60 weeks of follow-up
Chinese Version of the Brief Illness Perception Questionnaire (BIPQ) score
Tijdsspanne: 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.
At baseline and at 13, 36, and 60 weeks of follow-up
Cardiovascular re-hospitalization rate
Tijdsspanne: 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.
Assessed from the end of treatment through 60 weeks of follow-up.
Medication Adherence Report Scale (MARS-10) score
Tijdsspanne: 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.
Assessed at 13, 36, and 60 weeks of follow-up.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Nanfang Hospital, Southern Medical University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 december 2027

Studie voltooiing (Geschat)

1 december 2028

Studieregistratiedata

Eerst ingediend

18 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

30 augustus 2026

Eerst geplaatst (Werkelijk)

2 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 september 2026

Laatste update ingediend die voldeed aan QC-criteria

2 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NFEC-2026-428
  • 2025CR031 (Ander subsidie-/financieringsnummer: 2025 Nanfang Hospital of South)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

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-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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