Back to resultsMMEPT for Traumatic Brain Injury
Primary Purpose
Traumatic Brain Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RRTBIMS
Multimedia Multicultural Educational Program for TBI (MMEPT)
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury
Eligibility 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:
- PTA > 24 hours
- Trauma related intracranial neuroimaging abnormalities
- Loss of consciousness exceeding 30 minutes
- 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.
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MMPET Group
Control Group
Arm Description
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.
The Control Group will be comprised of equally diverse subset of patients who will receive Standard of Care Treatment.
Outcomes
Primary Outcome Measures
Difference in Rate of Retention
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02695043
Brief Title
MMEPT for Traumatic Brain Injury
Official Title
Multimedia Multicultural Educational Program for Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
July 5, 2019 (Actual)
Study Completion Date
July 5, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MMPET Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The Control Group will be comprised of equally diverse subset of patients who will receive Standard of Care Treatment.
Intervention Type
Behavioral
Intervention Name(s)
RRTBIMS
Intervention Description
TBI patients discharged from Bellevue inpatient rehabilitation and enrolled in the Rusk Rehabilitation Traumatic Brain Injury Model System (RRTBIMS)
Intervention Type
Behavioral
Intervention Name(s)
Multimedia Multicultural Educational Program for TBI (MMEPT)
Primary Outcome Measure Information:
Title
Difference in Rate of Retention
Time Frame
Up to One Week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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:
PTA > 24 hours
Trauma related intracranial neuroimaging abnormalities
Loss of consciousness exceeding 30 minutes
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamara Bushnik, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
MMEPT for Traumatic Brain Injury
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