- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07660237
Effects of a Transitional Care Program on Depression, Self-Efficacy, and Self-Care in Patients With Heart Failure
Effects of a Transitional Care Program on Depression, Self-Efficacy, and Self-Care in Patients With Heart Failure: A Randomized Controlled Trial
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Heart failure is a chronic condition associated with frequent hospitalizations, poor self-care behaviors, psychological distress, and reduced quality of life. Patients with heart failure often experience depression and inadequate self-management after hospital discharge, which may negatively affect treatment adherence and clinical outcomes.
Transitional care programs have been developed to improve continuity of care and support patients during the transition from hospital to home. Structured transitional care interventions may enhance patients' self-efficacy and self-care abilities while reducing depressive symptoms.
This randomized controlled trial aims to evaluate the effects of a structured transitional care program on depression, self-efficacy, and self-care behaviors in patients with heart failure. Eligible participants will be randomly assigned to either the intervention group or the usual care group. The intervention group will receive a structured transitional care program in addition to usual care, whereas the control group will receive usual care only.
Outcomes including depression, self-efficacy, and self-care behaviors will be measured before discharge and at 1 and 3 months after discharge using validated assessment instruments.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Taoyuan City
-
Guishan, Taoyuan City, Taiwan, 33305
- Chang Gung Memorial Hospital
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
Patients with a diagnosis of heart failure confirmed by a specialist physician. Patients with heart failure with reduced ejection fraction (HFrEF) and left ventricular ejection fraction (LVEF) ≤40%.
Age ≥20 years. Clear consciousness and no cognitive impairment. Ability to communicate in Mandarin, Taiwanese, or Hakka. Ability to complete the questionnaire independently or with assistance from the researcher.
Exclusion Criteria:
Patients who are unable to be discharged during the current hospitalization. Severe consciousness impairment, cognitive impairment, or severe mental illness affecting study participation.
Patients who are illiterate or unable to express themselves verbally. Patients who are bedridden long-term or unable to perform self-care activities. Patients who refuse to participate in the study. Patients who are already enrolled in a case management program.
Plano de estudo
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: Transitional Care Program Group
Participants received a structured transitional care program including discharge education, telephone follow-up, and home care support for 3 months after discharge.
|
A structured transitional care program including discharge education, telephone follow-up, and home care support for 3 months after discharge.
|
|
Comparador Ativo: Usual Care Group
Participants received routine discharge education and standard follow-up care provided by the hospital after dischar
|
Participants received standard discharge routine care provided by the hospital after discharge.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Depression Score Measured by the Patient Health Questionnaire-9 (PHQ-9)
Prazo: Baseline (before discharge), 1 month after discharge, and 3 months after discharge.
|
Depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9).
|
Baseline (before discharge), 1 month after discharge, and 3 months after discharge.
|
|
Change in Self-Efficacy Score Measured by the General Self-Efficacy Scale (GSES)
Prazo: Baseline (before discharge), 1 month after discharge, and 3 months after discharge.
|
Self-efficacy will be assessed using the General Self-Efficacy Scale (GSES).
|
Baseline (before discharge), 1 month after discharge, and 3 months after discharge.
|
|
Change in Self-Care Behavior Score Measured by the Self-Care of Heart Failure Index (SCHFI)
Prazo: Baseline (before discharge), 1 month after discharge, and 3 months after discharge.
|
Self-care behaviors will be assessed using the Self-Care of Heart Failure Index (SCHFI).
|
Baseline (before discharge), 1 month after discharge, and 3 months after discharge.
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 202300968B0
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .
Ensaios clínicos em Cuidados Transitórios
-
Indiana UniversityRecrutamentoUltrassom Point of Care (POCUS)Estados Unidos
-
Aalborg UniversityConcluídoUltrassonografia Point of Care (POCUS)Dinamarca
-
Asociacion Española Primera en SaludIntensive Care Unit Pasteur HospitalConcluídoUltrassom Point of CareUruguai
-
Aga Khan UniversityThe Hospital for Sick Children; Grand Challenges CanadaDesconhecidoUltrassom Point of CarePaquistão
-
Medical University of WarsawRecrutamentoUltrassom Point of Care (POCUS) | Hemodynamic Assessment | Bedside UltrasonographyPolônia
-
University of BolognaRecrutamentoHemodiálise | Avaliação de Volume | Ultrassom Point of Care (POCUS)Itália
-
University of Kansas Medical CenterBioNexus KC; Blue KC (Blue Cross Blue Shield)ConcluídoGravidez relacionada | Cuidados pré-natais | Doula Care | Saúde materna e infantil negraEstados Unidos
-
Tanta UniversityDesconhecidoDiâmetro da bainha do nervo óptico | Ultrassom Point of CareEgito
-
University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA); National Institute of Mental Health...ConcluídoTransgênero, HIV Continuum of CareEstados Unidos
-
Hospital for Special Surgery, New YorkConcluídoPeptídeo 1 semelhante ao glucagon | Ultrassom Gástrico | Ultrassom Point of CareEstados Unidos, Canadá
Ensaios clínicos em Structured Transitional Care Program
-
University of Maryland, BaltimoreUniversity of Maryland Medical SystemRetiradoInsuficiência cardíaca | Pneumonia | Hipertensão | Doença Pulmonar Obstrutiva Crônica | Readmissão do paciente | Diabetes Mellitus Mau ControleEstados Unidos