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Trial record 1 of 3 for:    Karen schwab
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Deployment Related Mild Traumatic Brain Injury (mTBI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01847040
Recruitment Status : Completed
First Posted : May 6, 2013
Last Update Posted : February 25, 2019
Sponsor:
Collaborators:
VISN 19 Mental Illness, Research, Education and Clinical Center
Womack Army Medical Center
USUHS Preventive Medicine and Biometrics
Information provided by (Responsible Party):
Karen Schwab, The Defense and Veterans Brain Injury Center

Tracking Information
First Submitted Date April 26, 2013
First Posted Date May 6, 2013
Last Update Posted Date February 25, 2019
Study Start Date September 2009
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 1, 2013)
  • Over time change in Concussive symptoms [ Time Frame: Baseline; 3 months; 6 months; 12 months ]
    Concussive symptoms are measured with 3 instruments: Neurobehavioral Symptom Inventory; Patient Health Questionnaire; Headache Questionnaire.
  • Change in Work Related Issues [ Time Frame: 3 months; 6 months; 12 months ]
    Measures of rates of return to duty; rates of return to work; and military job performance (for subjects remaining in military at follow-up).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 1, 2013)
  • Automated Neuropsychological Assessment Metrics (ANAM) [ Time Frame: Pre-deployment testing; and upon return from deployment ]
    The ANAM is a brief computerized cognitive assessment tool used for all individuals deploying to Afghanistan or Iraq; and administered after return from deployment.
  • Change in Social Interaction [ Time Frame: Baseline; 3 months; 6 months; 12 months ]
    Quality and frequency of interactions with family, friends, and partners. Includes marital status, living arrangements, best friend, people can depend upon for help, comparative quality of relationships before deployment and currently, frequency of communication.
  • Alcohol and caffeine use [ Time Frame: Baseline; 3 months; 6 months; 12 months ]
    Frequency of alcohol consumption, pre and post deployment consumption, receipt of help. Frequency of caffeine consumption, amount, consume with alcohol.
  • Health Utilization [ Time Frame: Baseline; 3 months; 6 months; 12 months follow-up ]
    Self-report and military data base information regarding type, and frequency of health care received. Also, self-reports on service needs.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Deployment Related Mild Traumatic Brain Injury (mTBI)
Official Title Deployment Related Mild Traumatic Brain Injury (mTBI): Incidence, Natural History, and Predictors of Recovery in Soldiers Returning From OIF/OEF
Brief Summary

The study will provide evidence on the long term outcomes of mTBI in service members returning from Afghanistan and Iraq. In addition, the study will provide evidence on mTBI incidence, and symptom patterns. Self-reported assessments at baseline and follow-ups will be combined with data on health care utilization and military job performance. The work, symptoms, and family interaction outcomes of returning soldiers screening positive for mTBI, combined mTBI and PTSD, and soldier controls will be compared at 3 months, 6 months, and at one year. The assessments over time will permit descriptions of symptom changes for these populations. It is likely the study will find similar findings to those of previous civilian studies - that concussive symptoms often resolve within months of injury. However, some soldier subsets may have chronic problems. Determining the incidence and outcomes of individuals with mTBI will assist medical providers in determining the types of follow-ups needed by returning service members and suggest the development of additional treatment interventions. These results may also inform treatment of civilian populations with mTBI.

The three primary hypotheses are:

  1. Concussive symptoms at the time of return from serving in Afghanistan and Iraq and symptoms persisting 3 months, 6 months, and 12 months after return will be associated with extent of exposure to combat, injury mechanism, associated injuries (co-occuring injuries), PTSD and other psychiatric co-morbidities, and number of deployment-related mTBIs.
  2. Returning troops reporting concussive symptoms at the time of return from deployment will have more work related problems at each follow-up (including lower rates of return to duty, return to work, and poor quality of work).
  3. The mTBI screening tool will be sensitive and specific to mTBI when compared to the criterion measure, which is a structured interview conducted by clinicians blinded to the screening results.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Cohort of soldiers returning to Fort Bragg and Fort Carson returning from deployment to Iraq and Afghanistan. National Guard and Army Reservists serving on Active Duty will also be included.
Condition Mild Traumatic Brain Injury
Intervention Not Provided
Study Groups/Cohorts
  • TBI while Deployed
    Active duty service members returning from Afghanistan or Iraq who were screened positive for Mild TBI
  • No TBI while Deployed
    Active duty service members returning from Afghanistan or Iraq who screened negative for mild TBI.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 21, 2019)
750
Original Estimated Enrollment
 (submitted: May 1, 2013)
1500
Actual Study Completion Date August 2014
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Must be returning from deployment in Iraq or Afghanistan
  2. Must have been screened for mild TBI on the deployment related study screening tool
  3. Must sign an informed consent/HIPAA authorization -

Exclusion Criteria:

  1. Returning from deployment for medical reasons, that is, medically evacuated to the Continental US
  2. Unable or unwilling to provide informed consent/HIPAA authorization -
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01847040
Other Study ID Numbers W81XWH-08-2-0105
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Karen Schwab, The Defense and Veterans Brain Injury Center
Study Sponsor The Defense and Veterans Brain Injury Center
Collaborators
  • VISN 19 Mental Illness, Research, Education and Clinical Center
  • Womack Army Medical Center
  • USUHS Preventive Medicine and Biometrics
Investigators
Principal Investigator: Karen Schwab, PhD The Defense and Veterans Brain Injury Center
PRS Account The Defense and Veterans Brain Injury Center
Verification Date May 2013