- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01002677
Behavioral Trial Studying Programmed Training to Improve Advocacy Skills for Individuals With Traumatic Brain Injury (MAP)
Midwest Advocacy Project: A Community-based Randomized Practical Behavioral Trial of Programmed Advocacy Training for Individuals With Traumatic Brain Injury and Their Significant Others
The Midwest Advocacy Project (MAP) is a community-based multiple-site randomized practical behavioral trial of advocacy skill training for individuals with traumatic brain injury (TBI), their families, and significant others. The purpose is to evaluate the efficacy of a 4-session advocacy training program to improve behavioral advocacy skills compared to self-directed advocacy training of the same session frequency. Groups will be randomly assigned to either a programmed group or a self-directed group in collaboration with the Brain Injury Associations of Minnesota, Iowa, and Wisconsin each year over the 5 year study period. The primary outcome is pre-post measures of written and verbal advocacy skill measured by the Advocacy Behavior Rating Scale.
It is hypothesized that subjects who receive programmed advocacy training will show greater positive change on pre-post measures of advocacy skill measures than subjects receiving self-directed training.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Iowa
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Urbandale, Iowa, Estados Unidos, 50322
- Brain Injury Association of Iowa
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55413
- Brain Injury Association of Minnesota
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Wisconsin
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Pewaukee, Wisconsin, Estados Unidos, 53072
- Brain Injury Association of Wisconsin
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 18 years of age or older
- moderate-severe TBI as indicated by one of the following:
- post traumatic amnesia (PTA) > 24 hours
- or loss of consciousness > 30 minutes
- or neuroimaging evidence of trauma-related intracranial abnormality
- Or the family/significant other of an individual with TBI meeting the above criteria
- 1 or more years post-injury
- Functional English speaker
- Signed consent to participate
Exclusion Criteria:
- Severe cognitive impairment as indicated by one or more of the following:
- Disorientation to person or year
- Unable to complete pre-program interview because of severe communication limitations
- Unable to remember important information given in the course of the pre-program interview, such as, time and place of program, number of sessions, and contact person
- Unable to complete the pre-program interview because of loss of emotional control, such as, extended tearfulness, sustained anger, verbal attack on interviewer
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Curriculum
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Day-long presentation of an advocacy training curriculum by the state's Brain Injury Association staff: One session per month for 4 consecutive months.
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Comparador activo: Self-directed
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Day-long group-based self-directed advocacy training activity: One session per month for 4 consecutive months.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Score on the Advocacy Behavior Rating Scale
Periodo de tiempo: Written and verbal (video) advocacy statements are obtained twice from each subject and rated by blinded investigators: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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Written and verbal (video) advocacy statements are obtained twice from each subject and rated by blinded investigators: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Score on Advocacy Activity Scale
Periodo de tiempo: The Advocacy Activity Scale score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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The Advocacy Activity Scale score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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Score on the Perceived Control Scale for Brain Injury
Periodo de tiempo: The Perceived Control Scale for Brain Injury score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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The Perceived Control Scale for Brain Injury score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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The Craig Hospital Inventory of Environmental Factors-Short Form
Periodo de tiempo: The Craig Hospital Inventory of Environmental Factors-Short Form score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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The Craig Hospital Inventory of Environmental Factors-Short Form score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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The Satisfaction with Life Scale
Periodo de tiempo: The Satisfaction with Life Scale is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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The Satisfaction with Life Scale is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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The SF-12
Periodo de tiempo: The SF-12 score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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The SF-12 score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
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Advocacy Activity Scale
Periodo de tiempo: Every 6 months after intervention until the end of the 5-year study period
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Every 6 months after intervention until the end of the 5-year study period
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Allen W Brown, MD, Mayo Clinic
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
- 08-000981
- H133A070013-09
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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