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| Name | Class |
|---|---|
| U.S. Army Medical Research and Development Command | FED |
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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 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Measure | Description | Time Frame |
|---|---|---|
| Test-retest Reliability SAFE-TBI | 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) Cohort 1: The primary endpoints for this sub-study (cohort) are 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. (Specific Aim 1). | Up to 6 weeks |
| Concordance Rate of Current VA Screening Instruments and the SAFE-TBI. | 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) Cohort 2: The primary endpoint for this sub-study is 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. (Specific Aim 2). | baseline |
| Sensitivity and Specificity of the SAFE-TBI | Sensitivity = True Positives/(True Positive + False Negatives) Specificity = True Negatives/(True Negative + False Positives) Cutoff 2 = At least moderate evidence of TBI vs. no or weak evidence of TBI | 6-months after medical evacuation |
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Inclusion Criteria:
Cohort 1:
Cohort 2:
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:
Exclusion Criteria:
Cohort 1:
Cohort 2:
Cohort 3:
Exclusion criteria for Cohort will be those used in the WRNMMC and Fort Belvoir Community Hospital Brain Indices Study as follows:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Laura A. Flashman, PhD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed National Military Medical Center | Washington D.C. | District of Columbia | 20307 | United States | ||
This difference is due to screened patients who were enrolled, but then found ineligible,were unreachable, or withdrew from study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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. |
| FG002 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Comparison of SAFE-TBI and VA Screen |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Test-retest Reliability SAFE-TBI | 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) Cohort 1: The primary endpoints for this sub-study (cohort) are 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. (Specific Aim 1). | Analyses done on Cohort 1, and a subset of Cohort 2 and 3 who got repeat interview. | Posted | Number | 95% Confidence Interval | kappa (reliability) | Up to 6 weeks |
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura A. Flashman, Ph.D. | Geisel School of Medicine at Dartmouth | 6036505824 | flashman@dartmouth.edu |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D004194 | Disease |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Togus VA Medical Center |
| Augusta |
| Maine |
| 04330 |
| United States |
| Manchester VA Medical Center | Manchester | New Hampshire | 03104 | United States |
| White River Junction VA Medical Center | White River Junction | Vermont | 05009-0001 | United States |
| Fort Belvoir Community Hopsital (FBCH) | Fort Belvoir | Virginia | 22060 | United States |
| Madigan Army Medical Center | Fort Lewis | Washington | 98431 | United States |
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 |
| BG002 | 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). |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Presence of TBI | 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 | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Concordance Rate of Current VA Screening Instruments and the SAFE-TBI. | 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) Cohort 2: The primary endpoint for this sub-study is 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. (Specific Aim 2). | Analyses done for Cohort 2 only. | Posted | Number | 95% Confidence Interval | percentage of participants | baseline |
|
|
|
| Primary | Sensitivity and Specificity of the SAFE-TBI | Sensitivity = True Positives/(True Positive + False Negatives) Specificity = True Negatives/(True Negative + False Positives) Cutoff 2 = At least moderate evidence of TBI vs. no or weak evidence of TBI | Data were only collected for cohort 3. | Posted | Number | percentage | 6-months after medical evacuation |
|
|
|
| 0 |
| 98 |
| 0 |
| 98 |
| EG001 | 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. | 0 | 115 | 0 | 115 |
| EG002 | 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). | 0 | 55 | 0 | 55 |
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| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| No Evidence |
|