Brain Injuries, TraumaticSAFE-TBINCT01554891
INTRuST Structured Assessment For Evaluation of TBI (SAFE-TBI)
An observational study of Brain Injuries, Traumatic, run by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Brain Injuries, Traumatic
- How many people
- 305 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2012to Mar 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: 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.
Who may be able to join
- Cohort 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.
- Screen positive on the PDHA TBI screen and referred to the Madigan Army Medical Center TBI clinic and Womack Army Medical Center.
- Capable of giving informed consent.
- Cohort 2:
- 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).
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- Screen positive on the VA Level 1 TBI screen.
- 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:
- Must be a patient at WRNMMC or FBCH
- Must be Defense Enrollment Eligibility Reporting System (DEERS) eligible.
- Must be diagnosed TBI positive or certified as TBI negative by a licensed medical practitioner using Department of Defense (DoD) criteria
- For mTBI subjects, an initial score of 13-15 on the Glasgow Coma Scale
- Aged 18-60
Who cannot join
- Cohort 1:
- Speech/language deficit of sufficient severity to preclude answering interview questions
- 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:
- Speech/language deficit of sufficient severity to preclude answering interview questions.
- 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).
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- 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:
- 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).
- Penetrating head injury.
- Record of drug or alcohol abuse or dependence in the past six months as documented in medical chart.
- 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.
- Taking intravenous medications for pain; participation will be delayed until such medication has been discontinued.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Togus VA Medical Center
Augusta, Maine, 04330
Fort Belvoir Community Hopsital (FBCH)
Fort Belvoir, Virginia, 22060
Madigan Army Medical Center
Fort Lewis, Washington, 98431
Manchester VA Medical Center
Manchester, New Hampshire, 03104
Walter Reed National Military Medical Center
Washington D.C., District of Columbia, 20307
White River Junction VA Medical Center
White River Junction, Vermont, 05009-0001
About this study
Official title: 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.
- Conditions
- Brain Injuries, Traumatic
- Keywords
- brain injuries, traumatic, military personnel, classification, diagnosis, instrumentation
- Medical subject headings
- Brain Injuries, Traumatic, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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
Measured: 6-months after medical evacuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
- Investigators
- Laura A. Flashman, PhD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554891
- Sponsor's protocol ID
- INTRuST-SAFE-TBI
- Acronym
- SAFE-TBI
- Status last verified
- Mar 2016
- First submitted
- 12 Mar 2012
- Last updated
- 3 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Initial Validation of the INTRuST Structured Assessment For Evaluation of TBI (SAFE-TBI)
- ClinicalTrials.gov ID
- NCT01554891
- Acronym / sponsor ID
- SAFE-TBI / INTRuST-SAFE-TBI
- Conditions
- Brain Injuries, Traumatic
- Keywords
- brain injuries, traumatic, military personnel, classification, diagnosis, instrumentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical ConsortiumUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- Feb 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 15 Mar 2012 (estimated)
- Results
- Posted 3 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (15 listed)
- 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.
- Screen positive on the PDHA TBI screen and referred to the Madigan Army Medical Center TBI clinic and Womack Army Medical Center.
- Capable of giving informed consent.
- 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).
- Screen positive on the VA Level 1 TBI screen.
Key exclusion criteria (14 listed)
- Speech/language deficit of sufficient severity to preclude answering interview questions
- 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).
- Speech/language deficit of sufficient severity to preclude answering interview questions.
- 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).
- Second level in-depth TBI evaluation done prior to SAFE TBI interview
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Test-retest Reliability SAFE-TBI
Time frame: Up to 6 weeks
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).
Concordance Rate of Current VA Screening Instruments and the SAFE-TBI.
Time frame: baseline
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).
Sensitivity and Specificity of the SAFE-TBI
Time frame: 6-months after medical evacuation
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura A. Flashman, PhD principal investigator
Dartmouth-Hitchcock Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, Traumatic, run by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test-retest Reliability SAFE-TBI (time frame: Up to 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2016.