NCT01558791

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,236

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2011

Completed
22 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
7 months until next milestone

First Posted

Study publicly available on registry

March 20, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

November 26, 2014

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

August 10, 2011

Results QC Date

November 3, 2014

Last Update Submit

March 8, 2019

Conditions

TBI

Keywords

PTSDpatient education handout

Outcome Measures

Primary Outcomes (3)

  • mTBI Questionnaire

    The primary outcome is knowledge gained about mTBI and illness perception. This is evaluated by number correct out of 10 true or false questions.

    One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.

  • Illness Perception - Current Symptoms

    Participants rate on a Likert Scale from 0-10 how much their current symptoms affect their life, with 0 being no affect, and 10 being severe.

    One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.

  • Illness Perception - Duration of Symptoms

    Participants rate on a Likert Scale from 0-10 how long they think their current symptoms will continue with 0 being a very short time and 10 being forever.

    One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.

Secondary Outcomes (1)

  • Feasibility Questionnaire

    One month- Providers complete a questionnaire within 1 month after data collection ends for the site.

Study Arms (2)

Arm 1

NO INTERVENTION

Participants will be "screened as usual". These participants will have the TBI screening as usual, without the educational intervention.

Arm 2

EXPERIMENTAL

Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.

Other: TBI handout

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.

Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Bay Pines VA Healthcare System, Pay Pines, FL

Bay Pines, Florida, 33708, United States

Location

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908, United States

Location

White River Junction VA Medical Center, White River Junction, VT

White River Junction, Vermont, 05009-0001, United States

Location

Hampton VA Medical Center, Hampton, VA

Hampton, Virginia, 23667, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Results Point of Contact

Title
Dr. Jessica Hamblen, PI
Organization
National Center for PTSD
Jessica.Hamblen@va.gov
802-296-5132

Study Officials

  • Jessica L Hamblen, PhD

    White River Junction VA Medical Center, White River Junction, VT

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2011

First Posted

March 20, 2012

Study Start

September 1, 2011

Primary Completion

September 1, 2012

Study Completion

January 1, 2013

Last Updated

March 25, 2019

Results First Posted

November 26, 2014

Record last verified: 2019-03

Locations

US(5)