MMEPT for Traumatic Brain Injury

NCT ID: NCT02695043

Last Updated: 2019-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2019-07-05

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).

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Multimedia Multicultural Educational Program for TBI (MMEPT)

Intervention Type: BEHAVIORAL

Control Group

The Control Group will be comprised of equally diverse subset of patients who will receive Standard of Care Treatment.

Group Type: ACTIVE_COMPARATOR

RRTBIMS

Intervention Type: BEHAVIORAL

TBI patients discharged from Bellevue inpatient rehabilitation and enrolled in the Rusk Rehabilitation Traumatic Brain Injury Model System (RRTBIMS)

Interventions

RRTBIMS

TBI patients discharged from Bellevue inpatient rehabilitation and enrolled in the Rusk Rehabilitation Traumatic Brain Injury Model System (RRTBIMS)

Intervention Type: BEHAVIORAL

Multimedia Multicultural Educational Program for TBI (MMEPT)

Intervention Type: BEHAVIORAL

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:

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tamara Bushnik, MD

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

15-00356

Identifier Type: -

Identifier Source: org_study_id