Development of Quality of Life Tool for TBI

NCT00714428 | Completed

• 1 other identifier: B6237-R
• Study Type: observational
• Target: 485
• Locations: 1 country
• Sites: 4

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).

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain Injury; Quality of Life

Outcome Measures

Primary Outcomes (1)

• development of an outcomes measure

  one time

Study Arms (3)

Group 1: Item Development

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

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.

Group 3: Instrument Development

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with deployment related traumatic brain injury and clinicians who treat those veterans.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead
• Northwestern University: collaborator
• University of Michigan: collaborator

Study Sites (4)

VA Palo Alto Health Care System

Palo Alto, California, 94304-1290, United States

Location

James A. Haley Veterans' Hospital

Tampa, Florida, 33612-4745, United States

Location

VA Medical Center, Minneapolis

Minneapolis, Minnesota, 55417, United States

Location

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

Related 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.0000000000000089.

  PMID: 25310294 RESULT

Biospecimen

Retention: NONE RETAINED

None retained

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Rodney D Vanderploeg, PhD

  James A. Haley Veterans' Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2008
• First Posted: July 14, 2008
• Study Start: April 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: September 1, 2012
• Last Updated: September 7, 2015

Record last verified: 2015-09

Locations

US (4)