CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 1,236 enrolled
Drug / intervention
TBI handoutother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01558791
NCT01558791Phase 1Completed

A Brief Educational Intervention to Improve TBI Screening Outcomes

VA Office of Research and Development·interventional·Posted Mar 20, 2012·Updated Mar 25, 2019

In Brief

A Phase 1 clinical trial evaluating TBI handout for TBI. Completed, enrolled 1,236 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTBI
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 20, 2012
Enrollment StartSep 1, 2011
Primary CompletionSep 1, 2012
Study CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 14.3 years ago

Interventions

TBI handoutother

The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover.