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MMEPT for Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT02695043
Recruitment Status : Recruiting
First Posted : March 1, 2016
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

Brief Summary:
The primary purpose of this research is to increase adherence to outpatient rehabilitation of chronically underserved individuals with traumatic brain injury (TBI). The intervention will be a TBI rehabilitation-focused education tool suitable for use with a wide variety of patients, including those with poor literacy skills and those with Limited English Proficiency (LEP), hereafter referred to as the Multimedia Multicultural Educational Program for TBI (MMEPT).

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Behavioral: RRTBIMS Behavioral: Multimedia Multicultural Educational Program for TBI (MMEPT) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multimedia Multicultural Educational Program for Traumatic Brain Injury
Study Start Date : March 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MMPET Group
This group of subjects will be comprised of a subset of culturally diverse patients admitted to the Bellevue the Traumatic Brain Injury Unit at Bellevue. Treatment will focus on improving awareness and comprehension of TBI and its long-term consequences, fostering increased trust in the TBI rehabilitation team, and conveying the importance of continued TBI follow up to maximize recovery.
Behavioral: Multimedia Multicultural Educational Program for TBI (MMEPT)
Active Comparator: Control Group
The Control Group will be comprised of equally diverse subset of patients who will receive Standard of Care Treatment.
Behavioral: RRTBIMS
TBI patients discharged from Bellevue inpatient rehabilitation and enrolled in the Rusk Rehabilitation Traumatic Brain Injury Model System (RRTBIMS)




Primary Outcome Measures :
  1. Difference in Rate of Retention [ Time Frame: Up to One Week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A medically documented (e.g., EMS report, hospital record, physician record) TBI as a result of a blow to the head requiring admission to an acute inpatient rehabilitation unit, meeting at least one of the following criteria for moderate to severe TBI:

    1. PTA > 24 hours
    2. Trauma related intracranial neuroimaging abnormalities
    3. Loss of consciousness exceeding 30 minutes
    4. GCS in emergency department of less than 13 (unless due to intubation, sedation or intoxication)
  • Proficient in Chinese (Mandarin or Cantonese), Spanish or English,
  • Willing to engage in the MMEPT and complete questionnaires,
  • Agreeing to participate (i.e., completion of informed consent and HIPAA documents).

Exclusion Criteria:

  • Preferred language (language with greatest proficiency) other than English, Chinese or Spanish,
  • In minimally conscious or vegetative state,
  • Significant symptoms of receptive aphasia, and
  • Any acute medical condition that, in the investigator's opinion, makes the person unsuitable or unable to participate. Participants enrolled in the study who are ultimately not discharged to the community at the completion of acute inpatient rehabilitation will be removed from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02695043


Contacts
Contact: Olanta Chandler bartoo02@nyumc.org
Contact: Michelle Smith mes247@nyumc.org

Locations
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Olanta Chandler       bartoo02@nyumc.org   
Contact: Michelle Smith       mes247@nyumc.org   
Principal Investigator: Tamara Bushnik, MD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Tamara Bushnik, MD New York University Medical School

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02695043     History of Changes
Other Study ID Numbers: 15-00356
First Posted: March 1, 2016    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System