Intervention Program for Patients With Mild Cognitive Impairment
A Model of Family Caregiving and Model-based Intervention Program for Family Caregivers of Patients With Mild Cognitive Impairment
Mild Cognitive Impairment (MCI) is a syndrome defined as a cognitive decline that is more severe than can be explained by an individual's age and education. One study in the United States found that MCI caregivers have experienced distress in association with caregiver burden. The prevalence of MCI for people age 65 and older ranges from 3% to 19%. Understanding the process of family caregiving provides a knowledge base for the health professionals when developing effective interventions. However, little is known about the phenomenon of family caregiving to patients with MCI in Taiwan.
Therefore, the purpose of the proposed study is to develop a theoretical model and a model-based intervention program for family caregivers of patients with MCI in Taiwan, and pilot test it in a clinical trial.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Mild Cognitive Impairment (MCI) is a syndrome defined as a cognitive decline that is more severe than can be explained by an individual's age and education. One study in the United States found that MCI caregivers have experienced distress in association with caregiver burden. The prevalence of MCI for people age 65 and older ranges from 3% to 19%. Understanding the process of family caregiving provides a knowledge base for the health professionals when developing effective interventions. However, little is known about the phenomenon of family caregiving to patients with MCI in Taiwan.
Therefore, the purpose of the proposed study is to develop a theoretical model and a model-based intervention program for family caregivers of patients with MCI in Taiwan, and pilot test it in a clinical trial.
To conduct a small scale pilot randomized control trial (total N = 60; 30 in each group) to pilot test the intervention program. The intervention group will receive the caregiver training program, and the control group received printed sheets with general information on MCI and dementia such as the causes, courses and symptoms. At 1 month, 3 months, and 6 months after the intervention group will complete the two-session training program, both groups will receive a follow-up assessment for preparedness, HRQoL and depressive symptoms. To minimize attrition, caregivers in both groups will receive monthly follow-up phone calls from the first to the sixth month. Changes in outcome variables will be analyzed using hierarchical linear models, in order to provide a reference for further formal clinical trial.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Taoyuan, Taiwán
- Chang Gung Memorial Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Patients' Inclusion Criteria:
- Age 65 years or older
- Being diagnosed as having MCI by a neurologist or a psychiatris
- Being cared for in a home setting
Patients' Exclusion Criteria:
- Terminally ill
Caregivers' Inclusion Criteria:
- Age 20 years or older
- Assuming primary responsibility for the care of the frail elderly person
Caregivers' Exclusion Criteria:
- Terminally ill
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Control group
Patients received only routine hospital care
|
|
|
Experimental: Intervention group
Patients received regular hospital routine care and model-based intervention program
|
Family Caregiver Intervention Program included three components: introduction of mild cognitive impairment, maintain and improve cognitive function, and health management.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Caregivers' preparedness was measured by the 10-item Caregiver Preparedness Scale.
Periodo de tiempo: 6 months
|
6 months
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Caregivers' competence was measured by the 17-item Competence Scale.
Periodo de tiempo: 6 months
|
6 months
|
|
Caregivers' quality of life was measured by the The 36-Item Short Form Health Survey (SF-36).
Periodo de tiempo: 6 months
|
6 months
|
|
Caregivers' depressive symptoms was measured by the the Center for Epidemiologic Studies Depression Scale.
Periodo de tiempo: 6 months
|
6 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Yea-Ing L Shyu, PhD, Chang Gung University
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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- NSC102-2314-B-182-051-MY3
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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. .