Traumatic Brain InjuryNCT01120054
Traumatic Brain Injury Among Homeless Veterans
An observational study of Traumatic Brain Injury and Homelessness, run by VA Eastern Colorado Health Care System at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Traumatic Brain Injury, Homelessness
- How many people
- 2,000 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2010to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Homeless Veterans
Who may be able to join
- At least 18 years of age, seeking homeless services at one of the VA Homeless Services Programs.
Who cannot join
- Failure to provide informed consent, not older than 89 years of age.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Department of Veterans Affairs, Eastern Colorado Health Care System
Denver, Colorado, 80220
Philadelphia VAMC
Philadelphia, Pennsylvania, 19104
Tampa VAMC
Tampa, Florida, 33612
About this study
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.
Read the 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.
- Conditions
- Traumatic Brain Injury, Homelessness
- Keywords
- Traumatic Brain Injury, Homelessness
- Medical subject headings
- Brain Injuries, Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
OSU TBI-ID
History of TBI
Measured: One Time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
- Collaborators
- US Department of Veterans Affairs, Corporal Michael J. Crescenz VA Medical Center, James A. Haley Veterans Administration Hospital
- Responsible party
- Principal investigator, Lisa Brenner, VA Eastern Colorado Health Care System
- Investigators
- Lisa A. Brenner, Ph. D., Principal investigator, VISN 19 MIRECC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120054
- Sponsor's protocol ID
- 10-0170
- Status last verified
- Jan 2019
- First submitted
- 6 May 2010
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traumatic Brain Injury Among Homeless Veterans
- ClinicalTrials.gov ID
- NCT01120054
- Acronym / sponsor ID
- 10-0170
- Conditions
- Traumatic Brain Injury, Homelessness
- Keywords
- Traumatic Brain Injury, Homelessness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Collaborators
- US Department of Veterans Affairs, Corporal Michael J. Crescenz VA Medical Center, James A. Haley Veterans Administration Hospital
- Study start
- May 2010 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 10 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Homeless Veterans
Key inclusion criteria (1 listed)
- At least 18 years of age, seeking homeless services at one of the VA Homeless Services Programs.
Key exclusion criteria (1 listed)
- Failure to provide informed consent, not older than 89 years of age.
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
OSU TBI-ID
Time frame: One Time
History of TBI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- MIRECC Web SiteLink provided by the sponsor.
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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.
Lisa A. Brenner, Ph. D. principal investigator
VISN 19 MIRECC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Homelessness, run by VA Eastern Colorado Health Care System at 3 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 1 inclusion and 1 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 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
OSU TBI-ID (time frame: One Time). 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 31 Jan 2019.