Traumatic Brain InjuryNCT02695043
MMEPT for Traumatic Brain Injury
A study testing RRTBIMS and Multimedia Multicultural Educational Program for TBI (MMEPT) in people with Traumatic Brain Injury, run by NYU Langone Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- RRTBIMS and Multimedia Multicultural Educational Program for TBI (MMEPT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 5 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: 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).
- Conditions
- Traumatic Brain Injury
- Being tested
- RRTBIMS, Multimedia Multicultural Educational Program for TBI (MMEPT)
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RRTBIMSBehavioural
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)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: RRTBIMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Rate of Retention
Measured: Up to One Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion5 Jul 2019
- Study completion5 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamara Bushnik, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695043
- Sponsor's protocol ID
- 15-00356
- Status last verified
- Aug 2019
- First submitted
- 24 Feb 2016
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimedia Multicultural Educational Program for Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02695043
- Acronym / sponsor ID
- 15-00356
- Conditions
- Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 5 Jul 2019 (actual)
- Study completion
- 5 Jul 2019 (actual)
- First posted
- 1 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MMPET Group | Experimental | Behavioral: Multimedia Multicultural Educational Program for TBI (MMEPT)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. |
| Control Group | Active comparator | Behavioral: RRTBIMSThe Control Group will be comprised of equally diverse subset of patients who will receive Standard of Care Treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RRTBIMSTBI patients discharged from Bellevue inpatient rehabilitation and enrolled in the Rusk Rehabilitation Traumatic Brain Injury Model System (RRTBIMS) | Behavioural | Control Group |
| Multimedia Multicultural Educational Program for TBI (MMEPT) | Behavioural | MMPET Group |
Primary outcome
Difference in Rate of Retention
Time frame: Up to One Week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamara Bushnik, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RRTBIMS and Multimedia Multicultural Educational Program for TBI (MMEPT) in people with Traumatic Brain Injury, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Rate of Retention (time frame: Up to One Week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2019.