- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT01714531
Improving Outcomes After Traumatic Injury: A Goal Management Approach (GMT)
21 kwietnia 2017 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
91
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Tennessee
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Nashville, Tennessee, Stany Zjednoczone, 37232
- Vanderbilt University Medical Center
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
21 lat do 80 lat (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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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Inne nazwy:
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Aktywny komparator: 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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Brak interwencji: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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D-KEFs Tower Test
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Dysexecutive Questionnaire
Ramy czasowe: 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
Ramy czasowe: 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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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Patient Health Questionnaire-9
Ramy czasowe: 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)
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Współpracownicy
Śledczy
- Główny śledczy: Kristin Archer, PhD, Vanderbilt School of Medicine
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 stycznia 2013
Zakończenie podstawowe (Rzeczywisty)
1 września 2016
Ukończenie studiów (Rzeczywisty)
1 września 2016
Daty rejestracji na studia
Pierwszy przesłany
22 października 2012
Pierwszy przesłany, który spełnia kryteria kontroli jakości
23 października 2012
Pierwszy wysłany (Oszacować)
26 października 2012
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
24 kwietnia 2017
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
21 kwietnia 2017
Ostatnia weryfikacja
1 kwietnia 2017
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 111484
- H133G120052 (Inny numer grantu/finansowania: NIDRR)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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