NCT02695043

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2019

Completed
Last Updated

August 12, 2019

Status Verified

August 1, 2019

Enrollment Period

3.3 years

First QC Date

February 24, 2016

Last Update Submit

August 8, 2019

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • Difference in Rate of Retention

    Up to One Week

Study Arms (2)

MMPET Group

EXPERIMENTAL

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)

Control Group

ACTIVE COMPARATOR

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

Behavioral: RRTBIMS

Interventions

RRTBIMSBEHAVIORAL

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

Control Group
Multimedia Multicultural Educational Program for TBI (MMEPT)BEHAVIORAL
MMPET Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Whole-Body Irradiation

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsInvestigative Techniques

Study Officials

  • Tamara Bushnik, MD

    New York University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2016

First Posted

March 1, 2016

Study Start

March 1, 2016

Primary Completion

July 5, 2019

Study Completion

July 5, 2019

Last Updated

August 12, 2019

Record last verified: 2019-08

Locations

US(1)