Development of Quality of Life Tool for TBI

Traumatic Brain Injury Clinical Trial

— TBIQOL  

Official title:

Development of a Quality of Life Tool for Deployment Related TBI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00714428
• Other study ID #: B6237-R
• Status: Completed
• Phase: N/A
• First received: July 8, 2008
• Last updated: September 3, 2015
• Start date: April 2009
• Est. completion date: September 2012

Study information

• Verified date: September 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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).

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 Furthermore, this approach is consistent with the FDA's draft guidance on patient reported outcome (PRO) measures development.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

• Status: Completed
• Enrollment: 485
• Est. completion date: September 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Locations

Country	Name	City	State
United States	VA Medical Center, Minneapolis	Minneapolis	Minnesota
United States	VA Palo Alto Health Care System	Palo Alto	California
United States	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia
United States	James A. Haley Veterans' Hospital	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	Northwestern University, University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.000000000 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	development of an outcomes measure		one time	No