MMEPT for Traumatic Brain Injury

August 8, 2019 updated by: NYU Langone Health

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in Rate of Retention
Time Frame: Up to One Week
Up to One Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Tamara Bushnik, MD, New York University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

July 5, 2019

Study Completion (Actual)

July 5, 2019

Study Registration Dates

First Submitted

February 24, 2016

First Submitted That Met QC Criteria

February 24, 2016

First Posted (Estimate)

March 1, 2016

Study Record Updates

Last Update Posted (Actual)

August 12, 2019

Last Update Submitted That Met QC Criteria

August 8, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-00356

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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