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- Registro de ensayos clínicos de EE. UU.
- Ensayo 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
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Taoyuan City
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Guishan, Taoyuan City, Taiwán, 33305
- Chang Gung Memorial Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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A structured transitional care program including discharge education, telephone follow-up, and home care support for 3 months after discharge.
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Comparador activo: Usual Care Group
Participants received routine discharge education and standard follow-up care provided by the hospital after dischar
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Participants received standard discharge routine care provided by the hospital after discharge.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Depression Score Measured by the Patient Health Questionnaire-9 (PHQ-9)
Periodo de tiempo: Baseline (before discharge), 1 month after discharge, and 3 months after discharge.
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Depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9).
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Baseline (before discharge), 1 month after discharge, and 3 months after discharge.
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Change in Self-Efficacy Score Measured by the General Self-Efficacy Scale (GSES)
Periodo de tiempo: Baseline (before discharge), 1 month after discharge, and 3 months after discharge.
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Self-efficacy will be assessed using the General Self-Efficacy Scale (GSES).
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Baseline (before discharge), 1 month after discharge, and 3 months after discharge.
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Change in Self-Care Behavior Score Measured by the Self-Care of Heart Failure Index (SCHFI)
Periodo de tiempo: Baseline (before discharge), 1 month after discharge, and 3 months after discharge.
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Self-care behaviors will be assessed using the Self-Care of Heart Failure Index (SCHFI).
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Baseline (before discharge), 1 month after discharge, and 3 months after discharge.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 202300968B0
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Atención de transición
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