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

This study has been completed.
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: March 2, 2016
Last verified: March 2016
Results First Received: September 21, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Brain Injuries, Traumatic

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This difference is due to screened patients who were enrolled, but then found ineligible,were unreachable, or withdrew from study.

Reporting Groups
  Description
Test-Retest Reliability of SAFE-TBI

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.

This component of the project assessed test-retest reliability (4-6 weeks), as well as the effects of different raters; Research Coordinators (TRCs) vs. experienced TBI Clinicians (TBICs) at the Madigan Army Medical Center (MAMC) TBI Clinic. Cohort 1 included subjects recently returned from deployment in Iraq or Afghanistan to Joint Base Lewis-McChord or veterans served at the White River Junction and Togus VAMC who screened positive for TBI on the PDHA. After the initial interview, the SAFE-TBI will be administered for the second time 4-6 weeks later. Participants were assigned to one of four assessment paradigms (i. TRC time 1 and TBIC time 2; ii. TRC time 1 and TRC time 2; iii. TBIC time 1 and TBIC time 2; or iv. TBIC time 1 and TRC time 2).

Comparison of SAFE-TBI and VA Screen

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 This component of the project assessed the correlation of the VA TBI Level 1 screen with the SAFE-TBI.

Participants were OEF/OIF/OND veterans (seeking care at the Northern New England VA Research Consortium [NNEVARC]) that screen positive for TBI on the VA screen when seeking treatment at the VA. Prior to the second level in-depth TBI evaluation, they were interviewed by a TRC using SAFE-TBI.

Sensitivity and Specificity of SAFE-TBI 200 participants in WRNMMC and Fort Belvoir Community Hospital Brain Indices Study (100 with mild TBI; 100 without mild TBI).

Participant Flow:   Overall Study
    Test-Retest Reliability of SAFE-TBI   Comparison of SAFE-TBI and VA Screen   Sensitivity and Specificity of SAFE-TBI
STARTED   105   120   57 
COMPLETED   98   115   55 
NOT COMPLETED   7   5   2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Test-Retest Reliability of SAFE-TBI 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
Comparison of SAFE-TBI and VA Screen 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
Sensitivity and Specificity of SAFE-TBI 200 participants in WRNMMC and Fort Belvoir Community Hospital Brain Indices Study (100 with mild TBI; 100 without mild TBI).
Total Total of all reporting groups

Baseline Measures
   Test-Retest Reliability of SAFE-TBI   Comparison of SAFE-TBI and VA Screen   Sensitivity and Specificity of SAFE-TBI   Total 
Overall Participants Analyzed 
[Units: Participants]
 98   115   55   268 
Age 
[Units: Years]
Mean (Standard Deviation)
 32.29  (9.30)   33.03  (8.68)   29.20  (8.56)   31.33  (8.5) 
Gender 
[Units: Participants]
       
Female   7   6   6   19 
Male   91   109   49   249 
Presence of TBI [1] 
[Units: Participants]
 91   115   55   261 
[1]

Cohort 1: the degree of agreement for SAFE-TBI outcome (no evidence of TBI vs. at least, weak evidence of TBI) across the two assessment time points (initial vs. 4 to 6 weeks), as well as the two rater types TRC vs. TBIC Cohort 2:the distribution of SAFE-TBI outcome (percent assigned to each evidence category of the SAFE-TBI) in a group of veterans who have screened positive on the VA TBI screen.

Cohort 3:Gold Standard comparison; the sensitivity and specificity of the SAFE-TBI to identify individuals with TBI



  Outcome Measures
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1.  Primary:   Test-retest Reliability SAFE-TBI   [ Time Frame: Up to 6 weeks ]

2.  Primary:   Concordance Rate of Current VA Screening Instruments and the SAFE-TBI.   [ Time Frame: baseline ]

3.  Primary:   Sensitivity and Specificity of the SAFE-TBI   [ Time Frame: 6-months after medical evacuation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Laura A. Flashman, Ph.D.
Organization: Geisel School of Medicine at Dartmouth
phone: 6036505824
e-mail: flashman@dartmouth.edu



Responsible Party: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
ClinicalTrials.gov Identifier: NCT01554891     History of Changes
Other Study ID Numbers: INTRuST-SAFE-TBI
Study First Received: March 12, 2012
Results First Received: September 21, 2015
Last Updated: March 2, 2016
Health Authority: United States: Institutional Review Board