Clinical trial NCT00714428: Development of Quality of Life Tool for TBI
Official title: Development of a Quality of Life Tool for Deployment Related TBI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Keywords: Traumatic Brain Injury
Quality of Life
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Northwestern University
name: University of Michigan
First posted: 2008-07-14
Enrollment: 485
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with deployment related traumatic brain injury and clinicians who treat those veterans.

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 Furthermore, this approach is consistent with the FDA's draft guidance on patient reported outcome (PRO) measures development.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

Eligibility criteria: 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

Primary outcomes:
measure: development of an outcomes measure
timeFrame: one time
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
city: Tampa
country: United States
facility: James A. Haley Veterans' Hospital
state: Florida
city: Minneapolis
country: United States
facility: VA Medical Center, Minneapolis
state: Minnesota
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center
state: Virginia
Study officials:
affiliation: James A. Haley Veterans' Hospital
name: Rodney D Vanderploeg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.