- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01177696
Intervention in Groups of Family Caregivers in Primary Health Care (IGFC)
VALIDATION OF AN INTERVENTION EFFECTIVE IN GROUPS OF FAMILY CAREGIVERS OF DEPENDENT PATIENTS FOR THEIR APPLICATION IN CENTRES OF PRIMARY HEALTH CARE.
Although Primary Health Care (PHC) Teams are used to deal with prevention and treatment of sanitary problems in adults with chronic diseases, they usually have a lack of experience in development of psychotherapeutic interventions. However, these interventions are the ones that achieve better results to reduce symptomatology and improve emotional state of caregivers.
The study aims to evaluate the effectiveness of an intervention of psychotherapy in improving the mental health and quality of life of caregivers. This intervention is based on theoretical approaches to care adjusted to cognitive theory, in order to be applied in primary health care centres.
To assess a cognitive-behavioural intervention to modify dysfunctional thoughts to properly face the care.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Methods/Design: Design: This is multicentre cross-sectional study, randomized in two parallel groups.
Setting: Two different urban PHC. Study population: 150 caregivers will be included by consecutive sampling. They provide mostly all the assistance to care-dependent familiars receiving attention in PHC Centers. Of chance form 100 caregivers will be assigned to the experimental group and 50 to the group control.
Measurements: Each caregiver will be evaluated on a personal interview. The caregivers' assessment protocol: 1) Assessment of different socio-demographic related to care, and caregiver's personal situation. 2)Care-dependent individuals will also be assessed by Barthel Index and Pfeiffer Questionnaire (SPMSQ). 3)Change in caregivers will be the principal measure: family function (Family APGAR Questionnaire), burden short questionnaire (Short Zarit Burden Interview), quality of life (Ruiz & Baca: 1993 Questionnaire), the Duke-UNK Functional Social Support Questionnaire, the General Health Questionnaire-12, and changes in Dysfunctional Thoughts about caring. 4) Intervention implementation measures will also be assessed.
Intervention: A psychotherapeutic intervention will be 8 sessions of 90 minutes in a pilot study groups. This intervention has been initially developed for family caregivers of patients with dementia.
Discussion: Psychotherapeutic interventions have been proved to obtain better results to reduce symptomatology and improve emotional state of caregivers. Moreover, this intervention has been proved to be effective in a different setting other than PHC, and was developed by professionals of Mental Health. If we found that this intervention is effective in PHC and with our professionals, it would be an important instrument to offer to caregivers of care-dependent patients.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Salamanca., España, 37003
- Primary care Research unit. La Alamedilla health centre
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Caregivers: They provide mostly all the assistance to care-dependent familiars receiving attention in PHC Centers
Exclusion Criteria:
- Those persons who did not share their place of residence with the relative, or who were impossible to locate either due to a change of address or being admitted to hospital or a nursing home, or on account of the patient's death were excluded
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: Control
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Experimental: psychotherapy
The study aims to evaluate the effectiveness of an intervention of psychotherapy in improving the mental health of caregivers. This intervention is based on theoretical approaches to care adjusted to cognitive theory, in order to be applied in primary health care centres. |
A psychotherapeutic intervention will be 8 sessions of 90 minutes in a pilot study groups.
This intervention has been initially developed for family caregivers of patients with dementia.
Otros nombres:
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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 caregivers will be the principal measure:
Periodo de tiempo: Initial and 6 months later
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family function (Family APGAR Questionnaire), burden short questionnaire (Short Zarit Burden Interview), quality of life (Ruiz & Baca: 1993 Questionnaire), the Duke-UNK Functional Social Support Questionnaire, the General Health Questionnaire-12, and changes in Dysfunctional Thoughts about caring.
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Initial and 6 months later
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Colaboradores e Investigadores
Investigadores
- Investigador principal: Rodriguez-Sanchez Emiliano, MD, La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain.
- Silla de estudio: Mora-Simón Sara, La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain.
- Silla de estudio: Porras-Santos Nieves, La Alamedilla Health Center, Castilla y León Health Service - SACYL, Salamanca, Spain.
- Silla de estudio: Patino-Alonso M. Carmen, MD, Departamento de Estadística. Universidad de Salamanca. Salamanca. Spain.
- Silla de estudio: Recio-Rodríguez José-Ignacio, La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain
- Silla de estudio: Becerro-Muñoz Concepción, MD, La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain
- Silla de estudio: Pérez-Arachaederra Diana, La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain
- Silla de estudio: Gómez-Marcos Manuel-Ángel, md, La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain
- Director de estudio: García Ortiz Luís, MD, La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
- GRS270A08
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