MMEPT for Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

Multimedia Multicultural Educational Program for Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02695043
• Other study ID #: 15-00356
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: July 5, 2019

Study information

• Verified date: August 2019
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 5, 2019
• Est. primary completion date: July 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Behavioral:
• RRTBIMS
TBI patients discharged from Bellevue inpatient rehabilitation and enrolled in the Rusk Rehabilitation Traumatic Brain Injury Model System (RRTBIMS)
• Multimedia Multicultural Educational Program for TBI (MMEPT)

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in Rate of Retention		Up to One Week