Traumatic Brain Injury (TBI) Screening Instruments

NCT00875329 | Completed Results

• 1 other identifier: SDR 08-411
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

Goal: The ultimate goal of this research program is to improve the health and quality of life for wounded warriors from Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) through screening, risk assessment, and outcome measurement. Purpose: The purpose of this study is to evaluate the reliability and validity of the existing Traumatic Brain Injury (TBI) Clinical Reminder Screen for OEF/OIF Veterans.

Conditions

Brain Injury

Keywords

Brain Injury

Outcome Measures

Primary Outcomes (1)

• Responses From the TBI Clinical Reminder

  The presence or absence of symptomatic TBI as determined by the VA TBI Clinical Reminder screen was compared to presence or absence of a deployment-related TBI as determined by the study's criterion standard (i.e., the VA TBI Clinical Identification Interview) to determine concordance and calculate sensitivity and specificity of the VA TBI Clinical Reminder screen. Sensitivity of the screen was the percent of positive screens of those determined to be true positives by the VA TBI Clinical Identification Interview. Specificity was the percentage of negatives screens that were determined to be true negatives by the VA TBI Clinical Identification Interview.

  April 2007 January 2012

Study Arms (1)

Group 1

A convenience sample of 97VHA patients who served during the OEF or OIF era, who are targeted in CPRS as requiring the TBI Clinical reminder will be included. This includes all ages, both sexes, and all races and ethnicities.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All those who have served in OEF/OIF who have been or need to be screened using the TBI Clinical Reminder

You may qualify if:

• Served in OEF/OIF

You may not qualify if:

• None

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

Related Publications (2)

• Belanger HG, Vanderploeg RD, Soble JR, Richardson M, Groer S. Validity of the Veterans Health Administration's traumatic brain injury screen. Arch Phys Med Rehabil. 2012 Jul;93(7):1234-9. doi: 10.1016/j.apmr.2012.03.003. Epub 2012 Mar 15.

  PMID: 22426242 RESULT

• Vanderploeg RD, Groer S, Belanger HG. Initial developmental process of a VA semistructured clinical interview for TBI identification. J Rehabil Res Dev. 2012;49(4):545-56. doi: 10.1682/jrrd.2011.04.0069.

  PMID: 22773258 RESULT

Biospecimen

Retention: NONE RETAINED

As there are no biospecimans, there is no biospeciman description.

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Rodney Vanderploeg, Ph.D
• Organization: Tampa VAMC

Rodney.Vanderploeg@va.gov

(813) 972-2000

Study Officials

• Rodney D. Vanderploeg, PhD

  James A. Haley Veterans' Hospital, Tampa, FL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2009
• First Posted: April 3, 2009
• Study Start: September 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: February 1, 2015
• Last Updated: July 3, 2015
• Results First Posted: December 12, 2014

Record last verified: 2015-06

Locations

US (1)