Traumatic Brain InjuryTBIQOLNCT00714428
Development of Quality of Life Tool for TBI
An observational study of Traumatic Brain Injury, run by US Department of Veterans Affairs at 4 sites in United States.
Trial summary
Objectives: The ultimate goal of this research program is to promote seamless, comprehensive care for Operation Enduring Freedom/ Operation Iraqi Freedom (OEF/OIF) veterans. The purpose of this study is to develop a psychometrically sound tool to measure health-related quality of life (HRQOL) applicable to wounded… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 485 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2009to Sep 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals with deployment related traumatic brain injury and clinicians who treat those veterans.
Who may be able to join
- enrolled in VA and diagnosed with a deployment-related TBI documented in computerized patient record system (CPRS)
- at least one year post injury
- greater than 18 years of age
- able to follow two step commands and
- English speaking
- Clinicians Inclusion Criteria:
Show all 12Show fewer
- Clinicians, including:
- physicians
- psychologists
- nurses
- social workers
- therapists who have provided care to wounded warriors with deployment-related TBI for at least three years
Who cannot join
- Veterans Exclusion criteria include:
- those veterans who are not yet discharged from initial rehabilitation (want patients to experience community based living environment)
- living in the community less than three months post initial rehabilitation, including residential care or long term care living environments
- No exclusion criteria for the clinicians
Trial locations and contacts
4 sites in 1 country.
United States4 sites
VA Medical Center, Minneapolis
Minneapolis, Minnesota, 55417
VA Palo Alto Health Care System
Palo Alto, California, 94304-1290
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249
James A. Haley Veterans' Hospital
Tampa, Florida, 33612-4745
About this study
Official title: Development of a Quality of Life Tool for Deployment Related TBI
Objectives: The ultimate goal of this research program is to promote seamless, comprehensive care for Operation Enduring Freedom/ Operation Iraqi Freedom (OEF/OIF) veterans. The purpose of this study is to develop a psychometrically sound tool to measure health-related quality of life (HRQOL) applicable to wounded warriors with TBI (deployment-related TBI).
Read the detailed description
Specific short-term objectives for this study include:
O1: Identify a parsimonious set of domains that capture HRQOL in deployment-related TBI.
O2: Construct and refine clinically-relevant HRQOL of life item banks for deployment-related TBI, in order to supplement the TBI-QOL and generic Neuro-QOL banks and extend the TBI/Neuro-QOL projects to address the unique issues facing wounded warriors with TBI.
O3:Utilize Item Response Theory methodology to refine and calibrate targeted and generic item banks for use with deployment-related TBI.
O4:Develop a short form, refining item sets and developing algorithms for future development of a computerized adaptive test.
Research Design: The proposed three-year prospective study will employ a mixed methods research design in three stages. Combining qualitative and quantitative methods maximizes the ability of the study team to design and validate a clinically sensitive HRQOL measure for wounded warriors with deployment-related TBI. Furthermore, this approach is consistent with the FDA's draft guidance on patient reported outcome (PRO) measures development.
Phase 1: Qualitative data obtained from focus groups of veterans and VA providers will be used to (a) evaluate the generic Neuro-QOL domains and items for relevance and appropriateness for use in deployment-related TBI and (b) identify new HRQOL domains and items specific to deployment-related TBI. [Objective #1] Phase 2: The generic and specific item banks will be field tested in a large sample of veterans with deployment-related TBI recruited from all 4 VA Polytrauma Rehabilitation Centers (PRCs). [Objective #2] Phase 3: Psychometric analyses, including item response theory (IRT) of field test data will be completed. The psychometric properties of the scale will be evaluated empirically. A short form will be developed, refining item sets and developing algorithms for future development of a computerized adaptive test (CAT). [Objectives #3 \& 4]
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Quality of Life
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Item Development | Individuals with TBI to provide input to relevant questions for quality of life measure in TBI | |
| Group 2: Item Development | Clinicians who treat those with deployment related TBI to obtain their feedback on relevant questions pertaining to quality of life measures in TBI. | |
| Group 3: Instrument Development | Individuals with deployment TBI who will complete the Beta version of the TBI QOL measure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of an outcomes measure
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 posted14 Jul 2008 (estimated)
- Study startApr 2009
- Primary completionDec 2011
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 485 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- Northwestern University, University of Michigan
- Responsible party
- Sponsor
- Investigators
- Rodney D Vanderploeg, PhD, Principal investigator, James A. Haley Veterans' Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714428
- Sponsor's protocol ID
- B6237-R
- Acronym
- TBIQOL
- Status last verified
- Sep 2015
- First submitted
- 8 Jul 2008
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Toyinbo PA, Vanderploeg RD, Donnell AJ, Mutolo SA, Cook KF, Kisala PA, Tulsky DS. Development and Initial Validation of Military Deployment-Related TBI Quality-of-Life Item Banks. J Head Trauma Rehabil. 2016 Jan-Feb;31(1):52-61. doi: 10.1097/HTR.0000000000000089.
PubMed 25310294
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Quality of Life Tool for Deployment Related TBI
- ClinicalTrials.gov ID
- NCT00714428
- Acronym / sponsor ID
- TBIQOL / B6237-R
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 485 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- Northwestern University, University of Michigan
- Study start
- Apr 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 14 Jul 2008 (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: The ultimate goal of this research program is to promote seamless, comprehensive care for Operation Enduring Freedom/ Operation Iraqi Freedom (OEF/OIF) veterans. The purpose of this study is to develop a psychometrically sound tool to measure health-related quality of life (HRQOL) applicable to wounded warriors with TBI (deployment-related TBI).
Detailed description
Specific short-term objectives for this study include:
O1: Identify a parsimonious set of domains that capture HRQOL in deployment-related TBI.
O2: Construct and refine clinically-relevant HRQOL of life item banks for deployment-related TBI, in order to supplement the TBI-QOL and generic Neuro-QOL banks and extend the TBI/Neuro-QOL projects to address the unique issues facing wounded warriors with TBI.
O3:Utilize Item Response Theory methodology to refine and calibrate targeted and generic item banks for use with deployment-related TBI.
O4:Develop a short form, refining item sets and developing algorithms for future development of a computerized adaptive test.
Research Design: The proposed three-year prospective study will employ a mixed methods research design in three stages. Combining qualitative and quantitative methods maximizes the ability of the study team to design and validate a clinically sensitive HRQOL measure for wounded warriors with deployment-related TBI. Furthermore, this approach is consistent with the FDA's draft guidance on patient reported outcome (PRO) measures development.
Phase 1: Qualitative data obtained from focus groups of veterans and VA providers will be used to (a) evaluate the generic Neuro-QOL domains and items for relevance and appropriateness for use in deployment-related TBI and (b) identify new HRQOL domains and items specific to deployment-related TBI. [Objective #1] Phase 2: The generic and specific item banks will be field tested in a large sample of veterans with deployment-related TBI recruited from all 4 VA Polytrauma Rehabilitation Centers (PRCs). [Objective #2] Phase 3: Psychometric analyses, including item response theory (IRT) of field test data will be completed. The psychometric properties of the scale will be evaluated empirically. A short form will be developed, refining item sets and developing algorithms for future development of a computerized adaptive test (CAT). [Objectives #3 \& 4]
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Item Development | – | –Individuals with TBI to provide input to relevant questions for quality of life measure in TBI |
| Group 2: Item Development | – | –Clinicians who treat those with deployment related TBI to obtain their feedback on relevant questions pertaining to quality of life measures in TBI. |
| Group 3: Instrument Development | – | –Individuals with deployment TBI who will complete the Beta version of the TBI QOL measure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with deployment related traumatic brain injury and clinicians who treat those veterans.
Key inclusion criteria (12 listed)
- enrolled in VA and diagnosed with a deployment-related TBI documented in computerized patient record system (CPRS)
- at least one year post injury
- greater than 18 years of age
- able to follow two step commands and
- English speaking
Key exclusion criteria (4 listed)
- those veterans who are not yet discharged from initial rehabilitation (want patients to experience community based living environment)
- living in the community less than three months post initial rehabilitation, including residential care or long term care living environments
- No exclusion criteria for the clinicians
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
development of an outcomes measure
Time frame: one time
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 7 Sep 2015.
- Results publication: PubMed 25310294Toyinbo PA, Vanderploeg RD, Donnell AJ, Mutolo SA, Cook KF, Kisala PA, Tulsky DS. Development and Initial Validation of Military Deployment-Related TBI Quality-of-Life Item Banks. J Head Trauma Rehabil. 2016 Jan-Feb;31(1):52-61. doi: 10.1097/HTR.0000000000000089.
Related trials for Traumatic Brain Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
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.
Rodney D Vanderploeg, PhD principal investigator
James A. Haley Veterans' Hospital
4 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, run by US Department of Veterans Affairs at 4 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 12 inclusion and 4 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 7 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
development of an outcomes measure (time frame: one time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00714428, which also lists 1 linked publication.
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 7 Sep 2015.