Self-Management Support for Acute Coronary Syndrome Patients After Hospital Discharge (ACS)
2 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
80
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Department of Cardiology, Nanfang Hospital
- Numéro de téléphone: 020-62707277
- E-mail: 243206095@qq.com
Lieux d'étude
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Guangdong
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Guangzhou, Guangdong, Chine, 510515
- Nanfang Hospital, Southern Medical University
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Contact:
- Department of Cardiology, Nanfang Hospital
- Numéro de téléphone: 020-62707277
- E-mail: 243206095@qq.com
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
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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.
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Comparateur actif: Control Group
Participants receive standard care and routine health education.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Heart Health Self-Efficacy and Self-Management Scale (HHSES) score
Délai: At baseline and at 13, 36, and 60 weeks of follow-up.
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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.
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At baseline and at 13, 36, and 60 weeks of follow-up.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Incidence of major adverse cardiovascular events (MACE) including heart failure, angina, arrhythmia, and recurrent myocardial infarction
Délai: From the end of treatment through 60 weeks of follow-up
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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.
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From the end of treatment through 60 weeks of follow-up
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Emergency department visit rate for cardiac-related reasons
Délai: From the end of treatment through 60 weeks of follow-up
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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.
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From the end of treatment through 60 weeks of follow-up
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Social Support Rating Scale (SSRS) score
Délai: At baseline and at 13, 36, and 60 weeks of follow-up
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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.
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At baseline and at 13, 36, and 60 weeks of follow-up
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Chinese Version of the Brief Illness Perception Questionnaire (BIPQ) score
Délai: At baseline and at 13, 36, and 60 weeks of follow-up
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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.
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At baseline and at 13, 36, and 60 weeks of follow-up
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Cardiovascular re-hospitalization rate
Délai: Assessed from the end of treatment through 60 weeks of follow-up.
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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.
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Assessed from the end of treatment through 60 weeks of follow-up.
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Medication Adherence Report Scale (MARS-10) score
Délai: Assessed at 13, 36, and 60 weeks of follow-up.
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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.
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Assessed at 13, 36, and 60 weeks of follow-up.
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 septembre 2026
Achèvement primaire (Estimé)
1 décembre 2027
Achèvement de l'étude (Estimé)
1 décembre 2028
Dates d'inscription aux études
Première soumission
18 août 2026
Première soumission répondant aux critères de contrôle qualité
30 août 2026
Première publication (Réel)
2 septembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
4 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NFEC-2026-428
- 2025CR031 (Autre subvention/numéro de financement: 2025 Nanfang Hospital of South)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
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.
Délai de partage IPD
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.
Critères d'accès au partage IPD
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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- ANALYTIC_CODE
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .