- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01714531
Improving Outcomes After Traumatic Injury: A Goal Management Approach (GMT)
21 de abril de 2017 actualizado por: Kristin Archer, Vanderbilt University Medical Center
Improving Trauma Outcomes: A Goal Management Approach
The majority of trauma survivors experience prolonged and profound physical and psychosocial disability, with up to 50% unable to return to productive employment.
The Centers for Disease Control (CDC) estimates that more than 1 million of these individuals experience a mild traumatic brain injury (TBI) and cost the United States nearly $17 billion each year.
Symptoms related to mild TBI result in cognitive, functional, and emotional impairments that can lead to vocational and social disability.
Long-term cognitive deficits include problems with memory and attention, and most importantly executive functioning.
Depressive and post-traumatic stress disorder (PTSD) symptoms are extremely common in individuals with cognitive impairment, occurring in up to 50% and 33% of individuals, respectively.
The investigators have found that 55% of trauma patients with mild TBI have profound cognitive impairments in executive functioning at one-year survival.
Executive functioning is defined as "a cognitive domain that controls the execution of complex activities of daily living essential for purposeful, goal directed behaviors."
Deficits in executive functioning are the most disabling of all cognitive impairments and affect a person's ability to manage effectively in one's personal and professional life.
Current literature shows that deficits in executive functioning contribute to reduced quality of life, difficulty in returning to work, and persistent psychological distress in various medical and surgical populations.
Cognitive rehabilitation has proven effective for decreasing persistent cognitive impairment and functional disability in patients with TBI.
The overall goal of cognitive rehabilitation is not only to improve a person's ability to process and interpret information but to increase self-confidence and self-efficacy for coping with emotional distress.
Despite evidence supporting the use of cognitive rehabilitation, few studies have systematically addressed cognitive treatment for individuals with mild TBI.
Therefore, the investigators propose to conduct a three-group randomized controlled trial to determine the efficacy of Goal Management Training (GMT), a structured manual-based intervention targeting executive functions that impact a person's ability to carry out daily tasks.
The investigators hypothesize that telephone-based GMT will improve cognitive functioning, functional status, and psychological health in trauma survivors with mild TBI.
Emerging research suggests that telephone rehabilitation is a feasible and effective alternative (with much broader applicability) to clinic-based interventions.
Trauma survivors with mild TBI have limited access to rehabilitation services due to financial constraints and mobility and geographic restrictions that render clinic-based rehabilitation impractical.
This clinical trial will recruit 90 trauma survivors with mild TBI and cognitive deficits in executive functioning.
Eligible participants will be randomized to either 10-week (1) telephone-based GMT; (2) telephone-based attention-control; or (3) usual care.
Primary outcomes will include observed and self-reported executive functioning and self-reported functional status as measured by a battery of standardized and previously validated cognitive tests and instruments, including the Delis-Kaplan Executive Function System Tower Test, the Dysexecutive Questionnaire, and the Functional Activities Questionnaire.
Secondary outcomes will consist of depressive and PTSD symptoms, as measured by the Patient Health Questionnaire-9 and PTSD Checklist - Civilian Version, respectively.
Outcome data will be collected at baseline (6 weeks after hospitalization) and at 4 month (treatment completion) and 7 month follow-up from hospital discharge.
Our cognitive rehabilitation intervention will serve to broadly disseminate evidenced-based cognitive strategies to a trauma population that has difficulty returning to productive life both inside and outside the home due to profound functional and psychological disability.
Findings from this study will support future research to improve the cognitive, functional and psychological health of patients following major trauma through innovative rehabilitation interventions and delivery methods.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
91
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
-
-
Tennessee
-
Nashville, Tennessee, Estados Unidos, 37232
- Vanderbilt University Medical Center
-
-
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 a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Determination of mild TBI using American Congress of Rehabilitation Medicine guidelines;
- No history of schizophrenia, or other psychotic disorder or suicidal intent;
- English speaking due to feasibility of employing study personnel to deliver and assess the study intervention;
- Age 21 years or older;
- Able to provide a telephone number and a stable address; and
- Presence of cognitive deficits in executive functioning (defined as 1 SD below the norm referenced mean on any 2 of the following neuropsychological tests, the D-KEF Tower Test, Trails B, and FAS)
Exclusion Criteria:
- Having a CT scan showing an intracranial hemorrhage;
- Current alcohol or substance abuse dependence (within the last 6 months);
- Persons with neurological history other than TBI (e.g., premorbid epilepsy, multiple sclerosis, Alzheimer's disease);
- Pre-existing cognitive impairment as determined by a validated surrogate or patient questionnaire (defined as a score greater than 3.3 on the IQCODE instrument;
- History of pre-morbid learning disability;and
- Involvement in current litigation
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Telephone-Based Goal Management Training
The GMT intervention targets cognitive deficits in executive functioning that impact a person's ability to carry out daily tasks.
Participants learn how to recognize and stop absentmindedness and automatic pilot and how to reduce daily errors and 'slips' through goal setting.
The telephone-based GMT condition includes 7 sessions delivered over the phone for 10 weeks.
|
Otros nombres:
|
Comparador activo: Telephone-Based Attention-Control
The attention group receives an educational intervention that is matched to the GMT intervention in terms of session length and contact with the study therapist.
The telephone-based attention condition includes 7 sessions delivered over 10 weeks.
Sessions address education on brain function and cognitive principles of memory, attention, language, perception, and motor skills.
Education on stress reduction, sleep hygiene, energy management, exercise, communication, and nutrition are also provided
|
|
Sin intervención: Usual Care Control
Participants in the control group will receive usual care as determined by the treating surgeon.
Usual care may include referral to a physical therapist, occupational therapist, psychiatrist, and/or psychologist and utilization of health services will be recorded during follow-up assessments.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
D-KEFs Tower Test
Periodo de tiempo: 7 months after hospital discharge
|
cognitive test for executive functioning
|
7 months after hospital discharge
|
Trail Making Test B
Periodo de tiempo: 7 months after hospital discharge
|
Cognitive test for set shifting and cognitive flexibility
|
7 months after hospital discharge
|
Sustained Attention to Response Test
Periodo de tiempo: 7 months after hospital discharge
|
Cognitive test for failures of sustained attention
|
7 months after hospital discharge
|
FAS Verbal Fluency Test
Periodo de tiempo: 7 months after hospital discharge
|
Cognitive test for verbal fluency
|
7 months after hospital discharge
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Dysexecutive Questionnaire
Periodo de tiempo: 7 months after hospital discharge
|
Self-reported executive functioning
|
7 months after hospital discharge
|
Functional Activities Questionnaire
Periodo de tiempo: 7 months after hospital discharge
|
Self-reported functional status
|
7 months after hospital discharge
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Patient Health Questionnaire-9
Periodo de tiempo: 7 months after hospital discharge
|
Self-reported measure of depressive symptoms
|
7 months after hospital discharge
|
PTSD Checklist-Civilian Version (PCL-C)
Periodo de tiempo: 7 months after hospital discharge
|
Self-reported measure of PTSD symptoms
|
7 months after hospital discharge
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kristin Archer, PhD, Vanderbilt School of Medicine
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
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 2013
Finalización primaria (Actual)
1 de septiembre de 2016
Finalización del estudio (Actual)
1 de septiembre de 2016
Fechas de registro del estudio
Enviado por primera vez
22 de octubre de 2012
Primero enviado que cumplió con los criterios de control de calidad
23 de octubre de 2012
Publicado por primera vez (Estimar)
26 de octubre de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de abril de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
21 de abril de 2017
Última verificación
1 de abril de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 111484
- H133G120052 (Otro número de subvención/financiamiento: NIDRR)
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. .
Ensayos clínicos sobre Lesión cerebral traumática
-
University of Dublin, Trinity CollegeDesconocidoAtletas de élite retirados de Brain Health
-
Assiut UniversityTerminadoMorfometría basada en Brain Voxel en ManiaEgipto
Ensayos clínicos sobre Telephone-Based Goal Management Training
-
Klimmendaal RevalidatiespecialistenReclutamientoLesión cerebral adquirida | Disfunción ejecutiva | Capacitación en gestión de objetivos | Capacitación en estrategia compensatoria | Juegos seriosPaíses Bajos
-
Mayo ClinicTerminadoCalidad de vida | Cirugía Gastrointestinal ComplejaEstados Unidos