NCT00714428

Development of Quality of Life Tool for TBI

Development of a Quality of Life Tool for Deployment Related TBI

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 485 (actual)
• Sponsor: US Department of Veterans Affairs · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 Furthermore, this approach is consistent with the FDA's draft guidance on patient reported outcome (PRO) measures development.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). \[Objectives #3 \& 4\]

Conditions

• Traumatic Brain Injury

Timeline

• Start date: 2009-04-01
• Primary completion: 2011-12-01
• Completion: 2012-09-01
• First posted: 2008-07-14
• Last updated: 2015-09-07

Locations

4 sites across 1 country: United States