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Medical and Resource Facilitation for Traumatic Brain Injury (MRFI Trial)

N/A

Waitlist Available

Led By Dmitry Esterov, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Functional English speaker

Diagnosis of traumatic brain injury

Timeline

Screening 3 weeks

Treatment Varies

Follow Up collected 3 times: enrollment, midpoint (6 months), and study end (18 months)

Awards & highlights

MRFI Trial Summary

This trial will test a new way of delivering medical and social services to people with TBIs, their families, and their primary care providers. The goal is to develop a model of care that is replicable, sustainable, and cost effective.

Who is the study for?

This trial is for adults over 18 with traumatic brain injury (TBI) living in Minnesota. Participants must have a phone and speak English. They should be eligible for the MN BIA Resource Facilitation program, which helps navigate life after TBI. It's not for those under 18 or with non-TBI brain disorders.Check my eligibility

What is being tested?

The study tests a new care model that combines Mayo Clinic's medical-rehab expertise with the MN Brain Injury Alliance's support services against usual community care. The goal is to see if telemedicine and other technologies can improve outcomes for TBI patients and their families.See study design

What are the potential side effects?

Since this trial focuses on service delivery rather than medication, it doesn't involve typical drug side effects. However, participants may experience issues related to technology use or changes in how they receive care.

MRFI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can speak and understand English well.

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I have been diagnosed with a traumatic brain injury.

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I am 18 years old or older.

MRFI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ collected 3 times: enrollment, midpoint (6 months), and study end (18 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~collected 3 times: enrollment, midpoint (6 months), and study end (18 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and collected 3 times: enrollment, midpoint (6 months), and study end (18 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Mayo-Portland Participation Index (M2PI)

Change in Participation Assessment with Recombined Tools-Objective (PART-O)

Change in Traumatic Brain Injury-Quality of Life (TBI-QOL)

Secondary outcome measures

Change in Clinical Satisfaction and Competency Rating Scale (CSCRS)

Change in Family Needs Questionnaire (FNQ)

Change in Telemedicine Perception Questionnaire (TMP-Q)

+3 more

MRFI Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Medical Care and Resource FacilitationExperimental Treatment1 Intervention

All intervention components will be delivered remotely: there will be no face-to-face interaction with the participants. The intervention is comprised of the clinical, educational, and supportive services of Mayo's Brain Rehabilitation Clinic integrated with the MN BIA RF program.

Group II: Usual careActive Control1 Intervention

Individuals with TBI, their family members and PCPs assigned to the usual care group will receive care and provide services as usual in their communities. Individuals with TBI assigned to the usual care group will receive RF as routinely provided by MN BIA.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Medical Care and Resource Facilitation

2019

N/A

~420

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,207 Previous Clinical Trials

3,766,725 Total Patients Enrolled

Minnesota Department of HealthOTHER_GOV

8 Previous Clinical Trials

225,663 Total Patients Enrolled

Minnesota Brain Injury AllianceUNKNOWN

Media Library

Medical and Resource Facilitation Intervention Clinical Trial Eligibility Overview. Trial Name: NCT03429322 — N/A

Family Research Study Groups: Medical Care and Resource Facilitation, Usual care

Family Clinical Trial 2023: Medical and Resource Facilitation Intervention Highlights & Side Effects. Trial Name: NCT03429322 — N/A

Medical and Resource Facilitation Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT03429322 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants currently being accepted for this research project?

"Data available on clinicaltrials.gov indicates that this medical experiment is not currently recruiting patients, despite being posted in November 2019 and last edited April 2022. Fortunately for those interested in research-based medicine, there are 914 other trials actively seeking participants."

Answered by AI

What goals are researchers hoping to accomplish through this research endeavor?

"This clinical trial seeks to measure the Change in Traumatic brain injury-Quality of Life (TBI-QOL) over a 18 month period, with patient assessment points at enrollment, midpoint (6 months), and study end. Secondary measurement outcomes include Caregiver burden self-report through Zarit Burden Inventory (ZBI) scores, a cost effectiveness determination via EQ-5D™ health outcome measurements, and an analysis of different family needs through Family Needs Questionnaire (FNQ)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Medical and Resource Facilitation Intervention After Traumatic Brain Injury

Allen Brown 2019. "Medical and Resource Facilitation Intervention After Traumatic Brain Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03429322.