- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00714428
Development of Quality of Life Tool for TBI (TBIQOL)
Development of a Quality of Life Tool for Deployment Related TBI
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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 Furthermore, this approach is consistent with the FDA's draft guidance on patient reported outcome (PRO) measures development.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]
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
California
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Palo Alto, California, Forenede Stater, 94304-1290
- VA Palo Alto Health Care System
-
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Florida
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Tampa, Florida, Forenede Stater, 33612-4745
- James A. Haley Veterans' Hospital
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55417
- VA Medical Center, Minneapolis
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Virginia
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Richmond, Virginia, Forenede Stater, 23249
- Hunter Holmes McGuire VA Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
development of an outcomes measure
Tidsramme: one time
|
one time
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Rodney D Vanderploeg, PhD, James A. Haley Veterans' Hospital
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- B6237-R
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