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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02300584
Distance Savvy: Testing Tele-Savvy, a Distance Dementia Family Caregiver Education Program
7 de septiembre de 2016 actualizado por: Kenneth Hepburn, Emory University
The purpose of this study is to refine and test the web-based delivery of a well-established in-person group program that provides information and education to informal caregivers (family and friends) of persons with Alzheimer's disease (or related illnesses).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The pilot project proposed will allow the investigators to use telehealth methods to deliver the Savvy Caregiver, an evidence-based dementia caregiver psychoeducation program, to family caregivers of community-dwelling persons with dementing illnesses (PWD) for whom attending in-person meetings poses difficulties.
The program - named Tele-Savvy - uses iPad and PC technology and on-line conferencing capacity to deliver the program through daily asynchronous self-learning modules and weekly, hour-long synchronous group meetings with program facilitators.
Tele-Savvy addresses all of the learning objectives of the current in-person Savvy program (Savvy entails in-person participation in six weekly two-hour group sessions).
Tipo de estudio
Intervencionista
Inscripción (Actual)
42
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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Atlanta, Georgia, Estados Unidos, 30329
- Emory Alzheimer's Disease Research Center
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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
21 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- an informal caregiver for a person with a dementing disorder, such as Alzheimer's disease
- able to speak, read, and understand English
- has access to a computer with internet connection
- lives in the US
Exclusion Criteria:
- unwilling to participate in data gathering
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: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Prototype Program
The Savvy Caregiver (Savvy) - program delivered on an iPad (a tablet computer with an internet connection) extends over a six week period.
Caregivers are asked to view brief daily videos (8-12 minutes) on the iPad.
Once each week, a group of caregivers joins in a videoconference (an hour) with one or two trained leaders to review material from the week and to learn new material.
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as a program delivered on an iPad with daily instructional video segments (8-12 minutes each)
as a program delivered on an iPad with daily instructional video segments (8-12 minutes each).
Videos may be modified after feedback from Prototype arm.
a tablet computer with an internet connection
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Experimental: Field Program
The Savvy Caregiver (Savvy) - program delivered on an iPad (a tablet computer with an internet connection) extends over a six week period.
Caregivers are asked to view brief daily videos (8-12 minutes) on the iPad.
Based on the feedback from the prototype program, the videos may vary.
Once each week, a group of caregivers joins in a videoconference (an hour) with one or two trained leaders to review material from the week and to learn new material.
|
as a program delivered on an iPad with daily instructional video segments (8-12 minutes each)
as a program delivered on an iPad with daily instructional video segments (8-12 minutes each).
Videos may be modified after feedback from Prototype arm.
a tablet computer with an internet connection
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
The number of participants who use at least half of the opportunities (half of the conferences and half of the daily lessons)
Periodo de tiempo: 6 weeks
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6 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in Zarit Burden Interview Score
Periodo de tiempo: Baseline, 6 weeks
|
A 22-item questionnaire in which subjects rate how often they experience negative feelings associated with caregiving.
Each item rated on a 5 point scale anchored at 0 for "never" and 4 for "nearly always."
Scores range from 0-88 with higher scores indicating increased burden of care.
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Baseline, 6 weeks
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Change in Center for Epidemiological Studies-Depression Scale Score
Periodo de tiempo: Baseline, 6 weeks
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A 20-item scale measuring general depression.
Scores range from 0-60, with higher scores indicating greater general depression.
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Baseline, 6 weeks
|
Change in State Trait Anxiety Index (STAI) Score
Periodo de tiempo: Baseline, 6 weeks
|
State Trait Anxiety Index questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales.
The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.
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Baseline, 6 weeks
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Change in Connor Davidson Resilience Scale (CD-RISC)
Periodo de tiempo: Baseline, 6 weeks
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The Connor-Davidson Resilience scale (CD-RISC) comprises of 25 items, each rated on a 5-point scale.
A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience.
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Baseline, 6 weeks
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Change in Perceived Stress Scale
Periodo de tiempo: Baseline, 6 weeks
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The Perceived Stress Scale is a 10-item questionnaire, on a 4-point scale (0 = Never, 4 = Very Often).
Scores range from 0-40, with higher scores reflecting greater perceived stress.
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Baseline, 6 weeks
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Change in Caregiver Self-Efficacy Score
Periodo de tiempo: Baseline, 6 weeks
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Caregiver self-efficacy was measured by the Revised Checklist for Caregiving Self-Efficacy; the scale consists of 17 items which are rated from 0 - 100% confidence.
The total score is summed from these percentages and ranges from 0 - 1700 where higher scores indicate a higher level of confidence.
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Baseline, 6 weeks
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Change in Personal Mastery scale
Periodo de tiempo: Baseline, 6 weeks
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Personal Mastery scale is a seven item, five-point Likert scale.
Scoring is done by summing item scores for a total score (possible range 7-35) with higher scores indicating higher levels of mastery.
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Baseline, 6 weeks
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Change in Revised Memory and Behavior Problem Checklist
Periodo de tiempo: Baseline, 6 weeks
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This scale measures the type/number of dementia patients disturbing behaviors, and how much they bother caregivers with 24 items describing possible troublesome behaviors that the patient might evidence in the past month.
Caregivers are first asked whether the dementia patient had displayed any of these in the time period, and secondly to rate on a 5-point scale (0=not at all; 4= extremely) how much this "bothered or upset" them.
A "conditional bother" score is calculated which is the "upset" or "bother" ratings for only the problematic behavior that occurred.
The scale refers to the caregiver.
Minimum score (best value)=0.
Maximum score (worst value)=4.
Higher values represent a worse outcome.
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Baseline, 6 weeks
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Change in Lawton Activities of Daily Living (ADL) / Instrumental Activities of Daily Living (IADL) Scale
Periodo de tiempo: Baseline, 6 weeks
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Lawton ADL/IADL is caregiver reported performance of personal and instrumental activities of daily living (ADLs).
There are 6 personal ADLs (i.e.
dressing, grooming, eating, etc) and 8 instrumental ADLs (i.e.
managing finances, transportation, food preparation) which are assessed.
Each item is awarded 2 points for fully independent, 1 point for minimal or moderate support required, and 0 points for full support.
Maximum score for independence with all personal and instrumental ADL's is 28.
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Baseline, 6 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Kenneth Hepburn, Ph.D., Emory University
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 noviembre de 2014
Finalización primaria (Actual)
1 de octubre de 2015
Finalización del estudio (Actual)
1 de octubre de 2015
Fechas de registro del estudio
Enviado por primera vez
21 de noviembre de 2014
Primero enviado que cumplió con los criterios de control de calidad
24 de noviembre de 2014
Publicado por primera vez (Estimar)
25 de noviembre de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
8 de septiembre de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
7 de septiembre de 2016
Última verificación
1 de septiembre de 2016
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB00074715
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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