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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01120054
Other study ID # 10-0170
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2010
Est. completion date December 2018

Study information

Verified date January 2019
Source VA Eastern Colorado Health Care System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Objectives include: 1) establishing a psychometrically sound traumatic brain injury (TBI) screening measure for use among homeless veterans; 2) identifying the prevalence of those that screen positive for TBI among homeless veterans seeking VA services; and 3) comparing psychiatric and psychosocial outcomes between those with and without a history of TBI.


Description:

Short-term Objectives include:

1. Establishing the criterion-related validity of the Traumatic Brain Injury-4 (TBI-4) questionnaire in the Veteran homeless population using the Ohio State University TBI-Identification Method (OSU TBI-ID) (Corrigan et al., 2007) as the gold standard for establishing traumatic brain injury (TBI) diagnosis.

2. Identifying the prevalence of those that screen positive for a lifetime history of TBI among homeless Veterans.

3. Comparing psychiatric outcomes (psychiatric hospitalizations, suicide attempts and deaths, and clinical contacts) and psychosocial outcomes between those with and without a lifetime history of TBI.


Recruitment information / eligibility

Status Completed
Enrollment 2000
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 89 Years
Eligibility Inclusion Criteria:

- At least 18 years of age, seeking homeless services at one of the VA Homeless Services Programs.

Exclusion Criteria:

- Failure to provide informed consent, not older than 89 years of age.

Study Design


Locations

Country Name City State
United States Department of Veterans Affairs, Eastern Colorado Health Care System Denver Colorado
United States Philadelphia VAMC Philadelphia Pennsylvania
United States Tampa VAMC Tampa Florida

Sponsors (4)

Lead Sponsor Collaborator
VA Eastern Colorado Health Care System Corporal Michael J. Crescenz VA Medical Center, James A. Haley Veterans Administration Hospital, US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary OSU TBI-ID History of TBI One Time
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