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The Family Caregiver Training Program for Caregivers of People With Dementia

5 de enero de 2016 actualizado por: Rosanne DiZazzo-Miller, Nova Southeastern University

The Family Caregiver Training Program for Caregivers of People With Dementia: A Randomized Control Trial

The purpose of this study is to examine the effectiveness of the Family Caregiver Training Program for caregivers of people with dementia, using a pretest posttest randomized control trial with 3-month follow-up. The Family Caregiver Training Program will consist of 3-hours and hence, three modules over the course of one day. Module one will present information on communication, eating, and nutrition, module two will focus on transfers and toileting, and module three will focus on bathing, grooming, and dressing. The control group will receive standard care as relevant to dementia family caregivers including general information on the progression of dementia, and helpful resources as suggested by the Alzheimer's Association. A convenience sample of 36 family caregivers will be recruited by flyers posted throughout local area community boards and Alzheimer's Association media outlets. A repeated measures ANOVA will be used to assess the group differences in knowledge and confidence at three time points (pre-intervention, post-intervention, and 3-months post-intervention). Changes in caregiver burden, depression, quality of life, and occupational performance and satisfaction will be assessed 3-months post-intervention.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

The main research question asks to what extent does participation in a structured 3-hour training module (i.e., The Family Caregiver Training Program) focused on assisting family caregiver's with the ADLs of people with dementia effect caregiver knowledge and confidence, which in turn may effect caregiver burden, depression, quality of life, and occupational performance and satisfaction. Aim 1 will examine the relationship between the Family Caregiver Training Program intervention and knowledge of and confidence in the occupation of caregiving. Aim 2 will explore the relationship between the occupation of caregiving and person characteristics including burden, depression, and quality of life. Aim 3 will explore the relationship between the changes in the occupation of caregiving and changes in occupational performance.

A feasibility of the Family Caregiver Training Program was established using a single pre- post- test design. A significant improvement in caregiver knowledge was found in all three areas of training: communication/nutrition (N=53, p<0.001), transfers and toileting (N=46, p=0.003), and bathing and dressing (N=45, p=0.10) (DiZazzo-Miller, Samuel, Barnas, & Welker, 2014). This proposed study is built on the feasibility study, with the addition of confidence, burden, depression, quality of life, and occupational performance and satisfaction as outcomes using a random assignment to control group design.

A convenience sample of 36 family caregivers was recruited through flyers, newsletters, and Alzheimer's Association media outlets. The intervention group received one two-hour training that included three modules. Module one presented information on communication, eating/feeding and nutrition; module two focused on transfers and toileting; and module three focused on bathing, grooming, and dressing. The control group received standard care based upon a packet developed by the Alzheimer's Association for physicians to distribute to families and caregivers after receiving a diagnosis of dementia.

Results from this study will be generalizable to Metro-Detroit area family caregivers. Findings may offer information to enhance the caregiver training literature in the field of occupational therapy on the impact a community-based activity of daily living training can have with dementia family caregivers.

Tipo de estudio

Intervencionista

Inscripción (Actual)

36

Fase

  • Fase 2
  • Fase 1

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

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Primary family caregiver as providing at least 4 hours/day of care at least 5 days/week
  2. At least 18 years of age
  3. Able to read and understand the English language
  4. Care recipients must have received an Alzheimer's or related dementia diagnosis

Exclusion Criteria:

  1. Caregivers who provide less than 4 hours/day of care at least 5 days/week
  2. Under 18 years of age
  3. Unable to read or understand the English language
  4. Have care recipients who have not received an Alzheimer's or related dementia diagnosis
  5. Formally trained/paid caregivers

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: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: The Family Caregiver Training Program
The experimental group received a 2 hour intervention training on activities of daily throughout the early, middle, and late stages of dementia including communication, eating/feeding, nutrition, bathing, grooming, dressing, toileting, and transferring.
The intervention consisted of a two-hour PowerPoint® presentation throughout three modules (i.e., communication, eating/feeding, and nutrition; transferring and toileting; and dressing, bathing, and grooming). Each module was followed by a hands-on demonstration and practice session, including how to properly position and feed an adult, transfer from a seated position to another seated position, and a case study on modifications and assistance to provide during dressing and grooming.
Sin intervención: Standard Care
The control group received a 1 1/2 hour training, however the information was based on what has been deemed standard care by the Alzheimer's Association.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Caregiver Change in Activities of Daily Living Knowledge
Periodo de tiempo: Pretest (i.e., immediately before training) to Posttest (i.e., immediately after training-on the same day) and 3-Months Posttest.
The ADL Knowledge Test is an 18-item, multiple-choice measure of caregiver assistance.
Pretest (i.e., immediately before training) to Posttest (i.e., immediately after training-on the same day) and 3-Months Posttest.
Caregiver Change in Confidence
Periodo de tiempo: Pretest (i.e., immediately before training) to Posttest (i.e., immediately after training-on the same day) and 3-Months Posttest.
The Caregiver Confidence Scale (Lewis et al., 2010) is a modified nine-item confidence scale used to assess caregiver confidence in their skills for caring, understanding of the stages of dementia, and communication with their care recipient.
Pretest (i.e., immediately before training) to Posttest (i.e., immediately after training-on the same day) and 3-Months Posttest.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The Zarit Burden Interview (22-item)
Periodo de tiempo: Pretest and 3-months posttest
The Zarit Burden Interview (Zarit et al., 1980) is a measure of perceived caregiver burden.
Pretest and 3-months posttest
The Beck Depression Inventory II
Periodo de tiempo: Pretest and 3-months posttest
The Beck Depression Inventory-II (Beck, Steer, Ball, & Ranieri, 1996; Gallagher, Nies, & Thompson, 1982) was used to measure caregiver depression.
Pretest and 3-months posttest
WHOQOL-BREF
Periodo de tiempo: Pretest and 3-months posttest
The World Health Organization Quality of Life (Brief) measure (WHO-QOL-BREF) was used to measure four domains, including physical health, psychological, social relationships, and environment.
Pretest and 3-months posttest
Occupational Performance
Periodo de tiempo: Pretest and 3-months posttest
This scale consists of asking one question related to performance for each of the three ADL modules within the Family Caregiver Training Program using a Likert scale of 1 to 10 (1 as not at all and 10 as extremely) on how well caregivers perform their occupation of caregiving. This was adapted from the Canadian Occupational Performance Measure (COPM).
Pretest and 3-months posttest
Occupational Satisfaction
Periodo de tiempo: Pretest and 3-months posttest
This scale consists of asking one question related to satisfaction for each of the three ADL modules within the Family Caregiver Training Program using a Likert scale of 1 to 10 (1 as not at all and 10 as extremely) on how satisfied caregivers are with their occupation of caregiving. This was adapted from the Canadian Occupational Performance Measure (COPM).
Pretest and 3-months posttest

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

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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

1 de enero de 2015

Finalización primaria (Actual)

1 de marzo de 2015

Finalización del estudio (Actual)

1 de julio de 2015

Fechas de registro del estudio

Enviado por primera vez

4 de enero de 2016

Primero enviado que cumplió con los criterios de control de calidad

5 de enero de 2016

Publicado por primera vez (Estimar)

7 de enero de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

7 de enero de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

5 de enero de 2016

Última verificación

1 de enero de 2016

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 12181423Exp

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. .

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