View Clinical Trial (Medical Research Study)
Reliability and Initial Validation of the INTRuST Structured Assessment For Evaluation of TBI (SAFE-TBI)
| City: |
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Augusta |
| State: |
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Maine |
| Zip Code: |
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04330 |
| Conditions: |
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Brain Injuries, Traumatic |
| Purpose: |
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The current study will evaluate the initial reliability and validity of a new instrument,
the INTRuST Structured Assessment for Evaluation of TBI (SAFE-TBI), in three samples of
Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND)
veterans. The SAFE-TBI is a relatively brief measure developed by INTRuST consortium
investigators and designed to be given by a trained administrator. It allows for a
determination of the level of evidence for exposure to a mild traumatic brain injury (TBI)
using the following categories: Strong, Moderate, Weak, or No Evidence of mild TBI. The
first objective is to determine the reliability (both test-retest and inter-rater) in a
sample of 100 veterans recently returned from deployment at Joint Base Lewis-McChord (Cohort
1), who have screened positive for TBI on the Post-Deployment Health Assessment. The second
objective is to determine the concordance between the SAFE-TBI and the VA TBI Screen in 100
OEF/OIF/OND veterans within the Northern New England VA Research Consortium (Cohort 2). The
third objective, to be carried out in a sample of 200 Walter Reed National Military Medical
Center (WRNMMC) OEF/OIF/OND patients (Cohort 3), is to determine the sensitivity and
specificity of the SAFE-TBI using the INTRuST study "Brain Indices of Risk for Posttraumatic
Stress Disorder after Mild Traumatic Brain Injury" initial evaluation as the "gold standard"
for TBI assessment.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
Cohort 1:
1. Military personnel returning to Joint Base Lewis-McChord from deployment in support
of OEF/OIF/OND between the ages of 18-60.
2. Screen positive on the PDHA TBI screen and referred to the Madigan Army Medical
Center TBI clinic.
3. Capable of giving informed consent.
Cohort 2:
1. Veterans of OEF/OIF/OND between the ages of 18-60, receiving care at any of the three
VAMCs that comprise the Northern New England VA Research Consortium (White River
Junction, VT; Manchester, NH; Togus, ME).
2. Screen positive on the VA Level 1 TBI screen.
3. Capable of giving informed consent.
Cohort 3:
Military Personnel participating in the INTRuST Consortium Brain Indices Study at Walter
Reed National Military Medical Center. This study has the following Inclusion Criteria:
1. Must be returning from deployment in Iraq, Afghanistan, or other theater of operation
2. Returning from deployment for medical reasons, i.e. medically evacuated
3. Must be a patient at WRNMMC
4. Must be diagnosed TBI positive or certified as TBI negative by a licensed medical
practitioner using Department of Defense (DoD) criteria
5. For mTBI subjects, an initial score of 13-15 on the Glasgow Coma Scale
6. Aged 18-60
Exclusion Criteria:
Cohort 1:
1. Speech/language deficit of sufficient severity to preclude answering interview
questions
2. Unable or unwilling to provide informed consent and Health Insurance Portability and
Accountability Act (HIPAA)authorization ("unable" includes cases in which the
potential subject cannot read and understand English well enough to provide informed
consent).
Cohort 2:
1. Speech/language deficit of sufficient severity to preclude answering interview
questions.
2. Unable or unwilling to provide informed consent and HIPAA authorization ("unable"
includes cases in which the potential subject cannot read and understand English well
enough to provide informed consent).
3. Second level in-depth TBI evaluation done prior to SAFE TBI interview
Cohort 3:
Exclusion criteria for Cohort will be those used in the WRNMMC Brain Indices Study as
follows:
1. Returning from deployment for non-medical reasons, i.e., completion of tour of duty
2. Unable or unwilling to provide informed consent and HIPAA authorization ("unable"
includes cases in which the potential subject cannot read and understand English well
enough to provide informed consent).
3. Penetrating head injury.
4. Record of drug or alcohol abuse or dependence in the past six months as documented in
medical chart.
5. Structured Clinical Interview for Diagnostic and Statistical Manual of Mental
Disorders -IV (SCID) reveals current or lifetime PTSD diagnosis related to life
events that occurred prior to most recent deployment.
6. Taking intravenous medications for pain; participation will be delayed until such
medication has been discontinued.
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| NCT ID: |
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NCT01554891 |
| Primary Contact: |
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Principal Investigator
Thomas W McAllister, MD
Dartmouth-Hitchcock Medical Center
Thomas W. McAllister, M.D.
Phone: (603) 650-5824
Email: Thomas.w.mcallister@dartmouth.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Augusta, Maine 04330
United States
Nancy Fischer
Email: Nancy.Fischer2@va.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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