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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00393627
Behavioral Sleep Intervention in Adult Family Homes
Efficacy of Behavioral Interventions to Improve Sleep in Adult Family Homes
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study addresses the clinical problem of sleep and nighttime behavioral disturbances in older adults with dementia living in board and care homes. Board and care facilities provide room and board, 24-hour supervision, and assistance with personal care tasks for two or more residents not related to the owner or operator. Many elderly persons who need residential care choose board and care facilities over the alternatives because of their small size and homelike environment.
Adult family homes (AFHs) are small board and care homes with 2-6 residents. Sleep and nighttime behavioral disturbances such as wandering, getting out of bed repeatedly, and day/night confusion are widespread among demented residents of AFHs, and are a leading cause for transfer into nursing homes. However, little is known about how best to treat these problems. Adult family homes vary widely in their type of ownership, staffing schedules, physical environment, resident eligibility criteria, physician access, level of family involvement, and ratio of private/public pay clients. There have been no sleep intervention studies conducted in AFHs, and strategies that have been shown to improve sleep in community-dwelling or nursing home patients may not be feasible or effective in AFH settings. Residents of AFHs have higher rates of functional and health problems that can contribute to sleep disturbances than do community-dwelling patients, and paid caregivers have demanding on-the-job responsibilities and schedules not typically faced by family caregivers. In contrast to skilled nursing facilities, AFH employees often live 24-hours on-site, have limited training in dementia care, and have no licensed health care professionals supervising day-to-day activities. Identification of strategies that could be used as part of a staff educational program to manage sleep and nighttime behavioral disturbances in this unique environment is sorely needed. If successful, such strategies would help residents remain in a less restrictive environment for a longer time, and enhance resident quality of life.
The goal of the project is test the efficacy of a 4-session behavioral intervention for improving sleep and reducing nighttime behavioral disturbances in dementia residents of adult family homes compared to AFH residents in a usual care control condition. This project builds upon previous research conducted by the Principal Investigator showing that brief behavioral interventions can improve sleep of persons with Alzheimer's disease who are living in the community with family caregivers. It applies rigorous methodology to determine whether these interventions are equally feasible and effective in adult family home settings, and whether they delay transition into higher levels of institutional care.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Washington
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Seattle, Washington, Estados Unidos, 98105
- University of Washington
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Probable or possible AD diagnosis
- Two or more sleep problems on the Sleep Disorders inventory
- Sleep problems occurring three or more times per week
- Living in an Adult Family Home with owner/operator and staff willing to participate
Exclusion Criteria:
- Previously diagnosed primary sleep disorder, e.g. sleep apnea or restless legs syndrome
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 1
Sleep Education Program: The Sleep Education Program (SEP) is conducted by a licensed MS- or PhD-level mental health professional experienced in working with persons with dementia and their caregivers.
The therapist meets with the AFH owner/operator and staff for four weekly sessions at the AFH.
The SEP content includes information about the causes of sleep problems in dementia, and provides staff with assistance in developing customized resident behavioral sleep plans focused on environmental (light and noise), dietary (eliminating caffeine and excessive nighttime fluids), and sleep scheduling (reducing afternoon/ evening napping; consistent, appropriate bed and rising times) factors that are commonly associated with resident nighttime awakenings.
A written manual is used.
|
The Sleep Education Program (SEP) is conducted by a licensed MS- or PhD-level mental health professional experienced in working with persons with dementia and their caregivers.
The therapist meets with the AFH owner/operator and staff for four weekly sessions at the AFH.
The SEP content includes information about the causes of sleep problems in dementia, and provides staff with assistance in developing customized resident behavioral sleep plans focused on environmental (light and noise), dietary (eliminating caffeine and excessive nighttime fluids), and sleep scheduling (reducing afternoon/ evening napping; consistent, appropriate bed and rising times) factors that are commonly associated with resident nighttime awakenings.
A written manual is used.
|
Comparador de placebos: 2
Routine medical care
|
The Sleep Education Program (SEP) is conducted by a licensed MS- or PhD-level mental health professional experienced in working with persons with dementia and their caregivers.
The therapist meets with the AFH owner/operator and staff for four weekly sessions at the AFH.
The SEP content includes information about the causes of sleep problems in dementia, and provides staff with assistance in developing customized resident behavioral sleep plans focused on environmental (light and noise), dietary (eliminating caffeine and excessive nighttime fluids), and sleep scheduling (reducing afternoon/ evening napping; consistent, appropriate bed and rising times) factors that are commonly associated with resident nighttime awakenings.
A written manual is used.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Actigraphy sleep estimates
Periodo de tiempo: 6 months
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6 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Susan M McCurry, Ph.D., University of Washington
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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
- 24091-G
- 03-7612-G 04
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