- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00271375
Evaluating the Carter Institute Caregiver Education Program at the VA
22 de abril de 2016 actualizado por: VA Office of Research and Development
This project implemented and evaluated the Rosalyn Carter Institute's (RCI's) educational and support program for caregivers, "Caring for You, Caring for Me." Specifically, it examined effects of the program upon family caregivers to older adults in the Atlanta area and elderly Veterans receiving outpatient primary care at the Atlanta Veterans Affairs Medical Center (VAMC).
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
Primary objectives of the research were:
- to evaluate user satisfaction with and perceived utility of the "Caring for You, Caring for Me" caregiver educational program among formal (VHA staff) and informal (family) caregivers who undergo the program;
- to assess effects of the program upon psychosocial and physical well-being of informal caregivers over a 1-year period .
Tipo de estudio
Intervencionista
Inscripción (Actual)
254
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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Georgia
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Decatur, Georgia, Estados Unidos, 30033
- VA Medical Center, Decatur
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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
55 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Family members of Veterans aged 65+ years and receiving care through the Atlanta VAMC's Clinic and Atlanta area.
- Must be the primary caregiver to someone 55 and over.
- Must have been assisting with at least one activity of daily living (ADL) for at least 6 months prior to beginning the intervention.
Exclusion Criteria:
- Caregivers are automatically excluded if veteran has a terminal illness with six months or less to live.
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 factorial
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Arm 1: Caring for you, Caring for me Educational Intervention
Educational Intervention
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5-week Education and Support Program for Caregivers of older adults.
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Experimental: Arm 2: Caring for you, caring for me + social worker
Educational + Social Work Intervention
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5-week Education and Support Program for Caregivers of older adults.+
augmentation with social worker
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Comparador de placebos: Arm 3: Control group usual care
Control group usual care
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Control group usual care
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
To Evaluate User Satisfaction With and Perceived Utility of the "Caring for You, Caring for Me" Caregiver Educational Program Among Formal (VHA Staff) and Informal (Family) Caregivers Who Undergo the Program
Periodo de tiempo: 18 Months
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This question addresses user satisfaction, in terms of caregiving perceived utility of the education program, as well as their actual use of knowledge and skills gained in their caregiving situation.
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18 Months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Subjective Health
Periodo de tiempo: Baseline, 6 Month Follow-up, 12 Month Follow-up
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Subjective Health was assessed using one of the eight subscales from the Medical Outcomes Study Health Survey Short Form (SF-36) which looked at the how the respondent (caregiver) perceived their own health currently and compared to a year ago.
Two items were based on a 5-point Likert scale (1 =Excellent and 5= Poor) with a total scale range between 1 and 5. Mean scores were calculated by finding the total sum divided by the total number of items, with higher scores indicating poorer outcomes.
Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).
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Baseline, 6 Month Follow-up, 12 Month Follow-up
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Physical Role Function
Periodo de tiempo: Baseline, 6 Month Follow-up, 12 Month Follow-up
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Physical Role Function was assessed using one of the eight subscales from the Medical Outcomes Study Health Survey Short Form (SF-36) which looked at how emotional or physical issues interfered with everyday social roles of the caregiver.
4 items were scored on a 5-point Likert scale (1 = All of the time and 5= None of the time) with total scale range between 1 and 5. Mean scores were calculated by finding the total sum divided by the total item number, with lower scores indicating poorer outcome.
Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).
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Baseline, 6 Month Follow-up, 12 Month Follow-up
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Physical Function
Periodo de tiempo: Baseline, 6 Month Follow-up, 12 Month Follow-up
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Physical function was assessed using one of the eight subscales from the Medical Outcomes Study Health Survey Short Form (SF-36) which is represented by 10 items tapping basic functional abilities of the caregiver (Does their health limit them in the following activities).
10 items were scored on a 3-Point Likert Scale with 1= Limited A lot and 3= Not Limited and total scale range between 1 and 3. Mean scores were calculated by finding the total sum divided by the total item number, with lower scores indicating poorer outcome.
Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).
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Baseline, 6 Month Follow-up, 12 Month Follow-up
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Depressive Symptoms
Periodo de tiempo: Baseline, 6 Month Follow-up, 12 Month Follow-up
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Depression symptoms were assessed using the Center for Epidemiological Studies Depression Scale (CES-D Short Form).
The CES-D is a 10 Question Scale with total scores ranging from 0-30.
Mean scores were calculated by finding the total sum divided by the total number of participants.
Any score equal to or above 10 is considered depressed.
Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).
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Baseline, 6 Month Follow-up, 12 Month Follow-up
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Caregiver Burden
Periodo de tiempo: Baseline, 6 Month Follow-up, 12 Month Follow-up
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Caregiver Burden was assessed using one of the five subscales from the revised Caregiver Appraisal Scale (CAS) through 9-items based on a 5-point likert scale with (1 = Never and 5= Nearly always).
Mean for the total scores, calculated as the total sum divided by the number of participants, where scores could range from 9 to 45 were calculated, with higher scores indicating poorer outcomes.
Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).
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Baseline, 6 Month Follow-up, 12 Month Follow-up
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Caregiver Satisfaction
Periodo de tiempo: Baseline, 6 Month Follow-up, 12 Month Follow-up
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Caregiver Satisfaction was assessed using one of the five subscales from the revised Caregiver Appraisal Scale (CAS) through 6-items based on a 5-point likert scale with (1 = Disagree A lot and 5= Agree A lot).
Mean for the total scores, calculated as the total sum divided by the number of participants, where scores could range from 6 to 30 were calculated, with higher scores indicating poorer outcomes.
Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).
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Baseline, 6 Month Follow-up, 12 Month Follow-up
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Caregiver Mastery
Periodo de tiempo: Baseline, 6 Month Follow-up, 12 Month Follow-up
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Caregiver Mastery was assessed using one of the five subscales from the revised Caregiver Appraisal Scale (CAS) through a 4-item question assessing a sense of doing a good job of care provision based on a 5-point likert scale with (5= Agree A lot and 1= Disagree A lot).
Mean for the total scores, calculated as the total sum divided by the number of participants, where scores could range from 5 to 20 were calculated, with higher scores indicating poorer outcome.
Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).
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Baseline, 6 Month Follow-up, 12 Month Follow-up
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Caregiver Efficacy
Periodo de tiempo: Baseline, 6 Month Follow-up, 12 Month Follow-up
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Caregiver Efficacy was assessed using the RIS Eldercare Self Efficacy Scale (RIS) a 10-item inventory addressing family caregiver's perception of their own ability to manage care provision challenges in the areas of relationship with the care recipient, instrumental care provision, and self-soothing (managing the strains of care provision) based on a 5-point likert scale with (1 = Im certain I CANNOT Do This and 5= Im certain I CAN Do This) with a total score range between1 and 5. Mean scores were calculated by finding the total sum divided by the total item number, higher scores indicating better outcome.
Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).
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Baseline, 6 Month Follow-up, 12 Month Follow-up
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Personal Mastery
Periodo de tiempo: Baseline, 6 Month Follow-up, 12 Month Follow-up
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Caregiver Personal Mastery was assessed using the Personal Mastery Scale which afforded a general measure of self-perceived ability to manage stressors and effect change in one's life through a 7-item question based on a 5-point likert scale with (5 = Agree A lot and 1= Disagree A lot) and a total score range between 1 and 5. Mean scores were calculated by finding the total sum divided by the total item number, with higher scores indicating poorer outcome.
Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).
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Baseline, 6 Month Follow-up, 12 Month Follow-up
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Perceived Social Support
Periodo de tiempo: Baseline, 6 Month Follow-up, 12 Month Follow-up
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Caregiver Perceived Social Support was assessed using the Medical Outcomes Study Social Support Survey (MOS-SSS) a 19-item scale that taps perceived emotional/informational, tangible, and affectionate support, and positive social interaction based on a 5-point likert scale with (1 = None of the time and 5= All of the time) with total score range between 1 and 5. Mean scores were calculated by finding the total sum divided by the total item number, with higher scores indicating better outcome.
Calculations were completed at each time interval (baseline, 6month follow-up, and 12month follow-up) and for each study arm (Arm 1, Arm 2 and Arm 3).
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Baseline, 6 Month Follow-up, 12 Month Follow-up
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Patricia Griffiths, PhD, Atlanta VAMC
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 octubre de 2005
Finalización primaria (Actual)
1 de agosto de 2009
Finalización del estudio (Actual)
1 de octubre de 2009
Fechas de registro del estudio
Enviado por primera vez
29 de diciembre de 2005
Primero enviado que cumplió con los criterios de control de calidad
29 de diciembre de 2005
Publicado por primera vez (Estimar)
30 de diciembre de 2005
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
30 de mayo de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
22 de abril de 2016
Última verificación
1 de abril de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- E4044-R
- IRB 2005-050240 (Otro identificador: Atlanta VAMC)
- IRB 278-2005 (Otro identificador: Emory University IRB)
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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Collinge and Associates, Inc.National Cancer Institute (NCI)Terminado
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VA Office of Research and DevelopmentTerminadoFactibilidad | Riesgo de suicidio | Aceptabilidad | Conectividad social | Pertenencia frustrada | Carga PercibidaEstados Unidos
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