Effects and Costs of a Day Care Centre Program Designed for People With Dementia (ECOD)
7 de febrero de 2020 actualizado por: Norwegian Centre for Ageing and Health
Effects and Costs of a Day Care Centre Program Designed for People With Dementia - a 24 Month Controlled Study
Attending day care centres with programs specifically designed for patients with dementia is believed to postpone admittance to nursing home as well as increase quality of life and well-being for both patients and their family caregivers.
We aim to investigate to what degree attendance in day care centres with programs for people with dementia is effective for patient and their caregivers whilst also cost efficient for society.
The study consists of a quasi-experimental trial with comparison group.
400 patients with dementia, along with a family caregiver, will be included in the trial.
Effects will be measured at baseline, after one and two years.
Data collection will be made at three levels; at patient level with measures of cognition, depression, quality of life, functioning in activities in daily living, neuropsychiatric symptoms and death; at caregiver level with measures of depression, level of burden and quality of life; and at societal level with measures of nursing home admittance, hospital stays and use of other health resources.
Additionally,a qualitative interview study will include 20 dyads from the main trial.
The main focus will be on how attending day care centre programs for patients with dementia affect the lives of both patients and caregivers.
Five of these dyads will be followed closely throughout the participation period to be used as case examples.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
A quasi experimental trial with a comparison group will be performed to evaluate the effect of the day care centre programs by comparing results from municipalities with (intervention group) and without (comparison group) a day care centre program designed for people with dementia using standardized assessment tools.
Furthermore, a survey will be used to explore the communication and co-operation between the professional staff at the day care centre, the patients and the family carers by administering questionnaires to all three parties.
Only patients with mild degree of dementia will be asked to participate in the questionnaire.
Finally, qualitative interviews will be made with 20 dyads of patients and family carers to collect their in depth experience with the day care centre program.
Five of these patients and their family carers will be followed closely as case examples for two years.
Tipo de estudio
Intervencionista
Inscripción (Actual)
261
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Tønsberg, Noruega, 3103
- Norwegian centre of Ageing and Health
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
65 años y mayores (Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Age of 65 years or more and living at home
- Patients in the day care centre group must have attended the centre for at least four weeks and have been there no longer than nine months
- Dementia of either Alzheimer's type, vascular dementia, dementia with Lewy bodies/Parkinson's disease or a mixture of these types of dementias
- Capacity to give informed consent as judged by the professional caregivers
- A Mini Mental Status Examination (MMSE) score of ≥15
- Having a family carer willing to participate, who see the patients personally at least once a week
- Attending the day care centre program at least twice a week
Exclusion Criteria:
- Having applied for nursing home placement
- Suffering from a serious co-morbid physical disorder with life expectancy less than six months
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Day care for patients with dementia
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Day care centres designed by the local authorities for patients with dementia
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Sin intervención: Cuidado como de costumbre
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Admittance to nursing home care
Periodo de tiempo: 24 months
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The number of patients admitted to nursing home care during a period of 24 months will be the primary outcome for the effect and the cost-consequence analysis
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24 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Quality of life for patients
Periodo de tiempo: 12 and 24 months
|
The quality of life for patients as measured by Quality of Life - Alzheimer's Disease (QoL-AD)
|
12 and 24 months
|
|
Change in the patient's functioning of daily living
Periodo de tiempo: 12 and 24 months
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The Physical self-Maintenance Scale and Instrumental Activities of Daily Living Scale will be used to assess change in the patient's function of daily living
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12 and 24 months
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Change in depressive symptoms in patients
Periodo de tiempo: 12 and 24 months
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The change in depressive symptoms will be assessed by Montgomery Asberg Depression Rating Scale (MADRS)by interviews with both patient and family carer and the Cornell Scale for Depression in Dementia (CSDD) by interviews with family carers and a professional caregiver
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12 and 24 months
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Change in patient's cognition
Periodo de tiempo: 12 and 24 months
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Patient's cognition will be assessed using the Mini Mental State Examination (MMSE) the Clock Drawing Test (CDT), the Trail Making Test A (TMT-A)and the 10 word test of the Consortium to Establish a Registry in Alzheimer's Disease (CERAD)
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12 and 24 months
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Change in neuropsychiatric symptoms in patients
Periodo de tiempo: 12 and 24 months
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The change in Neuropsychiatric symptoms will be assessed using Neuropsychiatric Inventory Questionnaire (NPI-Q)
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12 and 24 months
|
|
Patients death
Periodo de tiempo: 24 months
|
Number of patients that have died during 24 months will be registered
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24 months
|
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Change in level of burden in family carers
Periodo de tiempo: 12 and 24 months
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Level of burden for family carers will be assessed by using the Relative's Stress Scale (RSS)
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12 and 24 months
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Change in family carers depressive symptoms
Periodo de tiempo: 12 and 24 months
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The MADRS will be used to assess depressive symptoms in family carers
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12 and 24 months
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Change in quality of life for family carers
Periodo de tiempo: 12 and 24 months
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QoL-AD will be used to assess quality of life in family carers
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12 and 24 months
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Differences in the use of health resources between the intervention group and the control group
Periodo de tiempo: 12 and 24 months
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The use of health resources will be measured using the resource Utilization in Dementia scale (RUD)
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12 and 24 months
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Differences in quality adjusted life years between the intervention group and the control group
Periodo de tiempo: 12 and 24 months
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A generic instrument, the EuroQol (EQ-5D) will be used to measure quality adjusted life years
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12 and 24 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Knut Engedal, Professor, Norwegian Centre for Ageling and health
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de agosto de 2013
Finalización primaria (Actual)
1 de diciembre de 2017
Finalización del estudio (Actual)
31 de diciembre de 2017
Fechas de registro del estudio
Enviado por primera vez
11 de septiembre de 2013
Primero enviado que cumplió con los criterios de control de calidad
11 de septiembre de 2013
Publicado por primera vez (Estimar)
16 de septiembre de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de febrero de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
7 de febrero de 2020
Última verificación
1 de febrero de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NCAH-ECOD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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