Traumatic Brain Injury Among Homeless Veterans | NCT01120054

Studies
Traumatic Brain Injury Among Homeless Veterans

NCT01120054

Sponsor

VA Eastern Colorado Health Care System

Status

Completed

Last Update Posted

Jan 31, 2019Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Traumatic Brain Injury
Homelessness

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010Actual

Primary Completion Date

Dec 2018Actual

Completion Date

Dec 2018Actual

First Submitted Date

May 6, 2010

First Submission Date that Met QC Criteria

May 7, 2010

First Posted Date

May 10, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2019

Last Update Posted Date

Jan 31, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lisa Brenner, Director, VISN 19 MIRECC, VA Eastern Colorado Health Care SystemPrincipal Investigator

Lead Sponsor

VA Eastern Colorado Health Care SystemFED

Collaborators

Name	Class
US Department of Veterans Affairs	FED
Corporal Michael J. Crescenz VA Medical Center	FED
James A. Haley Veterans Administration Hospital	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Short-term Objectives include:

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
OSU TBI-ID	History of TBI	One Time

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Homeless Veterans

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lisa A. Brenner, Ph. D.	VISN 19 MIRECC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Veterans Affairs, Eastern Colorado Health Care System		Denver	Colorado	80220	United States

Label	URL
MIRECC Web Site	View source

Condition Browse Module

MeSH Terms

ID	Term
D000070642	Brain Injuries, Traumatic

Ancestor Terms

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided