NCT00852527

Brief Summary

The purpose of the proposed study is to determine the clinical validity and reliability of the VA's Traumatic Brain Injury (TBI) Clinical Reminder Screen and the Comprehensive TBI Evaluation used to screen for mild traumatic brain injury. Examining the reliability of the two screens will determine whether they are dependable. Verifying the clinical validity is important because valid screening and evaluation of mild TBI leads to accurate diagnosis and timely treatment. Accurate screening also improves clinical efficiency and ensures that resources are provided to those who need them most. The project findings are expected to advance the science of screening and diagnosis of a mild TBI event.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
456

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2009

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
3 years until next milestone

Results Posted

Study results publicly available

December 5, 2014

Completed
Last Updated

April 28, 2015

Status Verified

August 1, 2014

Enrollment Period

2.3 years

First QC Date

February 25, 2009

Results QC Date

November 4, 2014

Last Update Submit

April 6, 2015

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain InjuryScreeningDiagnosisRehabilitation Outcome

Outcome Measures

Primary Outcomes (1)

  • Diagnostic Accuracy of the TBI Clinical Reminder Screen (TCRS)

    Patients were initially assessed with the TBI Clinical Screen at their local VA. To assess the diagnostic accuracy of the TCRS, a dual-criterion approach was used. The VA Comprehensive TBI Evaluation (CTBIE), a secondary evaluation, served as the first criterion and the Structured TBI Diagnostic Interview (STDI) as the second criterion.

    All OEF/OIF Veterans to receive TCRS upon enrollment in VA

Study Arms (2)

Subjects with mild TBI

Presence of mild TBI defined by positive reference test

Subjects without mild TBI

Absence of mild TBI defined by negative reference test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Operation Enduring Freedom/ Operation Iraqi Freedom (OEF/OIF) Veterans

You may qualify if:

  • Patients included are those service members or Veterans who have been deployed in the OEF/OIF conflict and have screened positive or negative on the TBI Clinical Reminder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Southern Arizona VA Health Care System, Tucson, AZ

Tucson, Arizona, 85723, United States

Location

Edward Hines, Jr. VA Hospital

Hines, Illinois, 60141-5000, United States

Location

VA Medical Center, Lexington

Lexington, Kentucky, 40502, United States

Location

Related Publications (3)

  • Pape TL, High WM Jr, St Andre J, Evans C, Smith B, Shandera-Ochsner AL, Wingo J, Moallem I, Baldassarre M, Babcock-Parziale J. Diagnostic accuracy studies in mild traumatic brain injury: a systematic review and descriptive analysis of published evidence. PM R. 2013 Oct;5(10):856-81. doi: 10.1016/j.pmrj.2013.06.007.

    PMID: 24160300RESULT

  • Shandera-Ochsner AL, Berry DT, Harp JP, Edmundson M, Graue LO, Roach A, High WM Jr. Neuropsychological effects of self-reported deployment-related mild TBI and current PTSD in OIF/OEF veterans. Clin Neuropsychol. 2013;27(6):881-907. doi: 10.1080/13854046.2013.802017. Epub 2013 Jun 11.

    PMID: 23755991RESULT

  • Combs HL, Berry DT, Pape T, Babcock-Parziale J, Smith B, Schleenbaker R, Shandera-Ochsner A, Harp JP, High WM Jr. The Effects of Mild Traumatic Brain Injury, Post-Traumatic Stress Disorder, and Combined Mild Traumatic Brain Injury/Post-Traumatic Stress Disorder on Returning Veterans. J Neurotrauma. 2015 Jul 1;32(13):956-66. doi: 10.1089/neu.2014.3585. Epub 2015 Feb 26.

    PMID: 25350012RESULT

MeSH Terms

Conditions

Brain Injuries, TraumaticDisease

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Judith Babcock-Parziale, PI
Organization
Southern AZ VA Health Care System
judith.babcock@va.gov
520-7921450

Study Officials

  • Judi L Babcock-Parziale, PhD

    Southern Arizona VA Health Care System, Tucson, AZ

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2009

First Posted

February 27, 2009

Study Start

June 1, 2009

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

April 28, 2015

Results First Posted

December 5, 2014

Record last verified: 2014-08

Locations

US(3)