- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00714428
Development of Quality of Life Tool for TBI (TBIQOL)
Development of a Quality of Life Tool for Deployment Related TBI
Study Overview
Status
Conditions
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 Furthermore, this approach is consistent with the FDA's draft guidance on patient reported outcome (PRO) measures development.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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304-1290
- VA Palo Alto Health Care System
-
-
Florida
-
Tampa, Florida, United States, 33612-4745
- James A. Haley Veterans' Hospital
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55417
- VA Medical Center, Minneapolis
-
-
Virginia
-
Richmond, Virginia, United States, 23249
- Hunter Holmes McGuire VA Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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:
Clinicians, including:
- physicians
- psychologists
- nurses
- social workers
- therapists who have provided care to wounded warriors with deployment-related TBI for at least three years
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
development of an outcomes measure
Time Frame: one time
|
one time
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rodney D Vanderploeg, PhD, James A. Haley Veterans' Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B6237-R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Traumatic Brain Injury
-
Fondazione per la Ricerca Ospedale MaggioreCompletedBrain Injuries, Traumatic | Brain Injury Traumatic Severe | Brain Injury Traumatic ModerateItaly
-
Toronto Rehabilitation InstituteCentre for Aging and Brain Health Innovation; Ontario Neurotrauma FoundationUnknownBrain Injuries, Traumatic | Brain Injury, Chronic | Brain Injury Traumatic Severe | Brain Injury Traumatic ModerateCanada
-
Hospital Sirio-LibanesUniversity of Sao Paulo; Ministry of Health, Brazil; Hospital Sao Rafael; PROAD... and other collaboratorsRecruitingBrain Injury Traumatic Severe | Brain Injury Traumatic Moderate | Post Traumatic EpilepsyBrazil
-
University of TurkuTurku University Hospital; The Finnish Funding Agency for Technology and Innovation... and other collaboratorsCompletedBrain Injuries | TBI (Traumatic Brain Injury) | Brain Injuries, Traumatic | Traumatic Brain Injury | Injury, Brain, TraumaticFinland
-
Children's Hospital Medical Center, CincinnatiUniversity of CincinnatiCompletedBrain Injury Traumatic MildUnited States
-
BrainScope Company, Inc.RecruitingTBI (Traumatic Brain Injury) | Concussion, Brain | MTBI - Mild Traumatic Brain Injury | Closed Head InjuryUnited States
-
Institut National de la Santé Et de la Recherche...Institut National de Recherche en Informatique et en AutomatiqueNot yet recruitingTBI (Traumatic Brain Injury)France
-
University of Sao Paulo General HospitalUnknownTraumatic Brain Injury | Severe Brain Injury | Closed Traumatic Brain InjuryBrazil
-
First Affiliated Hospital Xi'an Jiaotong UniversityXijing Hospital; Second Affiliated Hospital of Wenzhou Medical University; Central... and other collaboratorsRecruitingMTBI - Mild Traumatic Brain Injury | Moderate Traumatic Brain InjuryChina
-
First Affiliated Hospital Xi'an Jiaotong UniversityHealth Science Center of Xi'an Jiaotong University; The Second Affiliated Hospital...RecruitingMTBI - Mild Traumatic Brain InjuryChina