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Traumatic Brain Injury (TBI) Screening Instruments

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00875329
First received: April 1, 2009
Last updated: June 4, 2015
Last verified: June 2015
Results First Received: June 10, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Cross-Sectional
Condition: Brain Injury

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Convenience Sample A convenience sample of 97VHA patients who served during the OEF or OIF era, who are targeted in CPRS as requiring the TBI Clinical reminder were included. This included all ages, both sexes, and all races and ethnicities. All participants provided responses to demographic information, a TBI Re-screen, and a semi-structured TBI Identification Clinical Interview.

Participant Flow:   Overall Study
    Convenience Sample  
STARTED     97  
COMPLETED     97  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Group 1 A convenience sample of 97VHA patients who served during the OEF or OIF era, who are targeted in CPRS as requiring the TBI Clinical reminder will be included. This includes all ages, both sexes, and all races and ethnicities.

Baseline Measures
    Group 1  
Number of Participants  
[units: participants]
  97  
Age  
[units: years]
Mean (Standard Deviation)
  41.6  (11.14)  
Gender  
[units: participants]
 
Female     10  
Male     87  



  Outcome Measures

1.  Primary:   Responses From the TBI Clinical Reminder   [ Time Frame: April 2007 January 2012 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Rodney Vanderploeg, Ph.D
Organization: Tampa VAMC
phone: (813) 972-2000 ext 6728
e-mail: Rodney.Vanderploeg@va.gov


Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00875329     History of Changes
Other Study ID Numbers: SDR 08-411
Study First Received: April 1, 2009
Results First Received: June 10, 2014
Last Updated: June 4, 2015
Health Authority: United States: Federal Government