- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01714531
Improving Outcomes After Traumatic Injury: A Goal Management Approach (GMT)
21 de abril de 2017 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Intervencional
Inscrição (Real)
91
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37232
- Vanderbilt University Medical Center
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
21 anos a 80 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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.
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Outros nomes:
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Comparador Ativo: 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
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Sem intervenção: 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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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D-KEFs Tower Test
Prazo: 7 months after hospital discharge
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cognitive test for executive functioning
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7 months after hospital discharge
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Trail Making Test B
Prazo: 7 months after hospital discharge
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Cognitive test for set shifting and cognitive flexibility
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7 months after hospital discharge
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Sustained Attention to Response Test
Prazo: 7 months after hospital discharge
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Cognitive test for failures of sustained attention
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7 months after hospital discharge
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FAS Verbal Fluency Test
Prazo: 7 months after hospital discharge
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Cognitive test for verbal fluency
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7 months after hospital discharge
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Dysexecutive Questionnaire
Prazo: 7 months after hospital discharge
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Self-reported executive functioning
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7 months after hospital discharge
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Functional Activities Questionnaire
Prazo: 7 months after hospital discharge
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Self-reported functional status
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7 months after hospital discharge
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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Patient Health Questionnaire-9
Prazo: 7 months after hospital discharge
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Self-reported measure of depressive symptoms
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7 months after hospital discharge
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PTSD Checklist-Civilian Version (PCL-C)
Prazo: 7 months after hospital discharge
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Self-reported measure of PTSD symptoms
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7 months after hospital discharge
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kristin Archer, PhD, Vanderbilt School of Medicine
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de janeiro de 2013
Conclusão Primária (Real)
1 de setembro de 2016
Conclusão do estudo (Real)
1 de setembro de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
22 de outubro de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de outubro de 2012
Primeira postagem (Estimativa)
26 de outubro de 2012
Atualizações de registro de estudo
Última Atualização Postada (Real)
24 de abril de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
21 de abril de 2017
Última verificação
1 de abril de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 111484
- H133G120052 (Número de outro subsídio/financiamento: NIDRR)
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