Phase 1
N=1,236
A Brief Educational Intervention to Improve Traumatic Brain Injury (TBI) Screening Outcomes
TBI
Bottom Line
View on ClinicalTrials.gov: NCT01558791 ↗Enrolled (actual)
1,236
Serious AEs
—
Results posted
Nov 2014
Primary outcome: Primary: mTBI Questionnaire — 5.38; 7.52 correct answers out of 10
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- TBI handout (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY mTBI Questionnaire |
5.38; 7.52 | — |
| PRIMARY Illness Perception - Current Symptoms |
6.92; 6.79 | — |
| PRIMARY Illness Perception - Duration of Symptoms |
7.59; 7.61 | — |
| SECONDARY Feasibility Questionnaire |
— | — |
Summary
This research study is designed to learn about Veterans' understanding of mild TBI (traumatic brain injury) and the VA TBI screening process. All OEF/OIF Veterans who come to one of the study-related clinics for TBI screening will be invited to participate. An educational handout on TBI will be given to half of the participants along with their TBI screening. The other half of the participants will have the usual TBI screening without the educational handout.
Veterans enrolled in the study will be asked to answer a 5-10 minute research questionnaire. The questionnaire will ask:
* About the individual: such as gender and branch of service
* About what happened during the TBI screening: such as whether the Veteran had a chance to ask the provider any questions
* About the Veteran's understanding of mild TBI: such as whether symptoms of mild TBI are long lasting
Veterans who receive the educational handout will be asked specific questions about the handout and its information.
Eligibility Criteria
Inclusion Criteria
- All OEF/OIF Veterans screened for TBI at the designated clinic at 1 of the 4 study sites (during the 6 months of recruitment) will be eligible.
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT01558791). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.