Development of Quality of Life Tool for TBI
- Conditions
- Traumatic Brain Injury
- Registration Number
- NCT00714428
- Lead Sponsor
- US Department of Veterans Affairs
- Brief 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 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 Furthermore, this approach is consistent with the FDA's draft guidance on patient reported outcome (PRO) measures development.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). \[Objectives #3 \& 4\]
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 485
- 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
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method development of an outcomes measure one time
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
VA Palo Alto Health Care System
🇺🇸Palo Alto, California, United States
James A. Haley Veterans' Hospital
🇺🇸Tampa, Florida, United States
VA Medical Center, Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Hunter Holmes McGuire VA Medical Center
🇺🇸Richmond, Virginia, United States
VA Palo Alto Health Care System🇺🇸Palo Alto, California, United States