INTRuST Structured Assessment For Evaluation of TBI (SAFE-TBI)

This study is currently recruiting participants.
Verified October 2013 by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
ClinicalTrials.gov Identifier:
NCT01554891
First received: March 12, 2012
Last updated: October 24, 2013
Last verified: October 2013

March 12, 2012
October 24, 2013
February 2012
September 2014   (final data collection date for primary outcome measure)
  • SAFE-TBI [ Time Frame: Change from baseline at six weeks ] [ Designated as safety issue: No ]
    Reliability of SAFE-TBI, as determined by test-retest and inter-rater reliability, in a sample of 100 veterans recently returned from deployment (Cohort 1)
  • Concordance rate of current VA screening instruments and the SAFE-TBI. [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Concordance rate of current VA TBI screening instruments and the SAFE-TBI in 100 OEF/OIF/OND veterans who have screened positive for TBI (Cohort 2)
  • Sensitivity and specificity of the SAFE-TBI [ Time Frame: 6-months after medical evacuation ] [ Designated as safety issue: No ]
    Sensitivity and specificity of the SAFE-TBI as determined by 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. SAFE-TBI will be administered about 6 months after return. (Cohort 3)
Same as current
Complete list of historical versions of study NCT01554891 on ClinicalTrials.gov Archive Site
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INTRuST Structured Assessment For Evaluation of TBI (SAFE-TBI)
Reliability and Initial Validation of the INTRuST Structured Assessment For Evaluation of TBI (SAFE-TBI)

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 and Fort Bragg (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) and Fort Belvoir Community Hospital 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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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Cohort 1: Active duty OEF/OIF/OND military personnel ages 18-60 who have recently screened positive for TBI following deployment.

Cohort 2: OEF/OIF/OND veterans ages 18-60 who have recently screened positive for TBI.

Cohort 3: Participants ages 18-60 in the INTRuST Consortium Brain Indices Study at WRNMMC or FBCH.

Brain Injuries, Traumatic
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  • Cohort 1
    100 OEF/OIF/OND veterans returning to Joint Base Lewis-McChord and Fort Bragg who screen positive for TBI on the Post Deployment Health Assessment (PDHA) TBI screen
  • Cohort 2
    100 OEF/OIF/OND veterans seeking care at Northern New England VA Research Consortium (NNEVARC) VA Medical Centers (VAMCs) who screen positive for TBI on VA Level 1 TBI screen
  • Cohort 3
    200 participants in WRNMMC and Fort Belvoir Community Hospital Brain Indices Study (100 with mild TBI; 100 without mild TBI).
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
September 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

Cohort 1:

  1. Military personnel returning to Joint Base Lewis-McChord and Fort Bragg 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 and Womack Army Medical Center.
  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 and Fort Belvoir Community Hospital. This study has the following Inclusion Criteria:

  1. Must be a patient at WRNMMC or FBCH
  2. Must be Defense Enrollment Eligibility Reporting System (DEERS) eligible.
  3. Must be diagnosed TBI positive or certified as TBI negative by a licensed medical practitioner using Department of Defense (DoD) criteria
  4. For mTBI subjects, an initial score of 13-15 on the Glasgow Coma Scale
  5. 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 and Fort Belvoir Community Hospital Brain Indices Study as follows:

  1. 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).
  2. Penetrating head injury.
  3. Record of drug or alcohol abuse or dependence in the past six months as documented in medical chart.
  4. 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.
  5. Taking intravenous medications for pain; participation will be delayed until such medication has been discontinued.
Both
18 Years to 60 Years
No
Contact: Laura A. Flashman, PhD (603) 650-0404 Laura.A.Flashman@hitchcock.org
United States
 
NCT01554891
INTRuST-SAFE-TBI
Yes
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
U.S. Army Medical Research and Materiel Command
Principal Investigator: Laura A. Flashman, PhD Dartmouth-Hitchcock Medical Center
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP