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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 : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

February 24, 2016
March 1, 2016
January 26, 2018
March 2016
April 2018   (Final data collection date for primary outcome measure)
Difference in Rate of Retention [ Time Frame: Up to One Week ]
Same as current
Complete list of historical versions of study NCT02695043 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
MMEPT for Traumatic Brain Injury
Multimedia Multicultural Educational Program for Traumatic Brain Injury
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).
Not Provided
Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Traumatic Brain Injury
  • Behavioral: RRTBIMS
    TBI patients discharged from Bellevue inpatient rehabilitation and enrolled in the Rusk Rehabilitation Traumatic Brain Injury Model System (RRTBIMS)
  • Behavioral: Multimedia Multicultural Educational Program for TBI (MMEPT)
  • 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.
    Intervention: 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.
    Intervention: Behavioral: RRTBIMS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
125
Same as current
December 2018
April 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Olanta Chandler bartoo02@nyumc.org
Contact: Michelle Smith mes247@nyumc.org
United States
 
 
NCT02695043
15-00356
No
Not Provided
Not Provided
New York University School of Medicine
New York University School of Medicine
Not Provided
Principal Investigator: Tamara Bushnik, MD New York University Medical School
New York University School of Medicine
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP