Development of Quality of Life Tool for TBI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

485 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-09-30

Brief Summary

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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).

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Detailed Description

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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 Furthermore, this approach is consistent with the FDA's draft guidance on patient reported outcome (PRO) measures development.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

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Traumatic Brain Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group 1: Item Development

Individuals with TBI to provide input to relevant questions for quality of life measure in TBI

No interventions assigned to this group

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.

No interventions assigned to this group

Group 3: Instrument Development

Individuals with deployment TBI who will complete the Beta version of the TBI QOL measure.

No interventions assigned to this group

Eligibility Criteria

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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, 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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes