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

2 de setembro de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

80

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Department of Cardiology, Nanfang Hospital
  • Número de telefone: 020-62707277
  • E-mail: 243206095@qq.com

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Comportamental: 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.
Comparador Ativo: Control Group
Participants receive standard care and routine health education.
Comportamental: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Heart Health Self-Efficacy and Self-Management Scale (HHSES) score
Prazo: 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.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Incidence of major adverse cardiovascular events (MACE) including heart failure, angina, arrhythmia, and recurrent myocardial infarction
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Nanfang Hospital, Southern Medical University

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de setembro de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2027

Conclusão do estudo (Estimado)

1 de dezembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

18 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

30 de agosto de 2026

Primeira postagem (Real)

2 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • NFEC-2026-428
  • 2025CR031 (Número de outro subsídio/financiamento: 2025 Nanfang Hospital of South)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano 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.

Prazo de Compartilhamento de 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.

Critérios de acesso de compartilhamento 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.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF
  • ANALYTIC_CODE
  • CSR

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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