- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00714428
Development of Quality of Life Tool for TBI (TBIQOL)
Development of a Quality of Life Tool for Deployment Related TBI
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Specific short-term objectives for this study include:
O1: Identify a parsimonious set of domains that capture HRQOL in deployment-related TBI.
O2: Construct and refine clinically-relevant HRQOL of life item banks for deployment-related TBI, in order to supplement the TBI-QOL and generic Neuro-QOL banks and extend the TBI/Neuro-QOL projects to address the unique issues facing wounded warriors with TBI.
O3:Utilize Item Response Theory methodology to refine and calibrate targeted and generic item banks for use with deployment-related TBI.
O4:Develop a short form, refining item sets and developing algorithms for future development of a computerized adaptive test.
Research Design: The proposed three-year prospective study will employ a mixed methods research design in three stages. Combining qualitative and quantitative methods maximizes the ability of the study team to design and validate a clinically sensitive HRQOL measure for wounded warriors with deployment-related TBI. Furthermore, this approach is consistent with the FDA's draft guidance on patient reported outcome (PRO) measures development.
Phase 1: Qualitative data obtained from focus groups of veterans and VA providers will be used to (a) evaluate the generic Neuro-QOL domains and items for relevance and appropriateness for use in deployment-related TBI and (b) identify new HRQOL domains and items specific to deployment-related TBI. [Objective #1] Phase 2: The generic and specific item banks will be field tested in a large sample of veterans with deployment-related TBI recruited from all 4 VA Polytrauma Rehabilitation Centers (PRCs). [Objective #2] Phase 3: Psychometric analyses, including item response theory (IRT) of field test data will be completed. The psychometric properties of the scale will be evaluated empirically. A short form will be developed, refining item sets and developing algorithms for future development of a computerized adaptive test (CAT). [Objectives #3 & 4]
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Palo Alto, California, Estados Unidos, 94304-1290
- VA Palo Alto Health Care System
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Florida
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Tampa, Florida, Estados Unidos, 33612-4745
- James A. Haley Veterans' Hospital
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55417
- VA Medical Center, Minneapolis
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Virginia
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Richmond, Virginia, Estados Unidos, 23249
- Hunter Holmes McGuire VA Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- enrolled in VA and diagnosed with a deployment-related TBI documented in computerized patient record system (CPRS)
- at least one year post injury
- greater than 18 years of age
- able to follow two step commands and
- English speaking
Clinicians Inclusion Criteria:
Clinicians, including:
- physicians
- psychologists
- nurses
- social workers
- therapists who have provided care to wounded warriors with deployment-related TBI for at least three years
Exclusion Criteria:
Veterans Exclusion criteria include:
- those veterans who are not yet discharged from initial rehabilitation (want patients to experience community based living environment)
- living in the community less than three months post initial rehabilitation, including residential care or long term care living environments
No exclusion criteria for the clinicians
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Group 1: Item Development
Individuals with TBI to provide input to relevant questions for quality of life measure in TBI
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Group 2: Item Development
Clinicians who treat those with deployment related TBI to obtain their feedback on relevant questions pertaining to quality of life measures in TBI.
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Group 3: Instrument Development
Individuals with deployment TBI who will complete the Beta version of the TBI QOL measure.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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development of an outcomes measure
Periodo de tiempo: one time
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one time
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Rodney D Vanderploeg, PhD, James A. Haley Veterans' Hospital
Publicaciones y enlaces útiles
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
- B6237-R
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