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NCT03429322 · ClinicalTrials.gov registry record · NA
Medical and Resource Facilitation Intervention After Traumatic Brain Injury
A NA study of Brain Injuries, Traumatic and Family, sponsored by Mayo Clinic.
- Completed
- Registry status
- NA
- Development phase
- 415
- Enrollment target
- 1
- Study location
NCT03429322: Completed NA study of Brain Injuries, Traumatic and Family, sponsored by Mayo Clinic.
NCT03429322 is a NA study of Brain Injuries, Traumatic and Family that has completed, run by Mayo Clinic. The registered enrollment target is 415 participants, above the 236-participant average among 21 other Brain Injuries, Traumatic trials with a reported enrollment target (76% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03429322, a NA study of Brain Injuries, Traumatic and Family, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 415 participants
- Enrollment target
- 1
- Study location
Study Summary
Mayo Clinic's Traumatic Brain Injury (TBI) Model System Center (TBIMSC) will capitalize on longstanding collaborations with the non-profit Minnesota Brain Injury Alliance (MN BIA) and Minnesota Department of Health (MDH) to test a new way of delivering medical and social services. This trial will address chronic unmet needs expressed by individuals with TBI and their families in the U.S. pertaining to the ineffective connection to specialized medical and community resources in the transition from hospital to community-based care, limited access to TBI experts, and lack of primary care provider (PCP) knowledge about the complex needs of individuals with TBI. Target populations for this study are: 1) individuals with TBI eligible for MN BIA provided Resource Facilitation (RF), 2) their families, and 3) their PCPs. This clinical trial will use a theory-driven complex behavioral intervention that integrates the medical-rehabilitation, therapy, and TBI expertise of Mayo's Brain Rehabilitation Clinic (BRC) with MN BIA's highly developed RF program (a free two-year telephone support service offering assistance in navigating life after brain injury). Mayo Clinic's medical-rehabilitation expertise will be integrated with RF services to deliver direct clinical care remotely using telemedicine and other information and communication technology to test whether outcomes over time are better in a group receiving this model of care compared to a group that receives usual care in their communities. Costs between usual care and intervention groups will be compared in collaboration with the MDH. The overarching goal is development of a replicable, sustainable, and cost effective model of telemedicine care that integrates TBIMS Centers and BIAs nationwide and builds TBI expertise and capacity among PCPs.
Primary Outcome
A primary participation assessment and outcome measure for phone follow-up
Conditions Studied
Interventions
- OTHER Usual Care
- BEHAVIORAL Medical Care and Resource Facilitation
Study Locations (1)
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 415 participants |
| Start Date | 2019-01-11 |
| Est. Completion | 2022-12-03 |
| Phase | NA |
What the finished NCT03429322 record still lists
NCT03429322 is an interventional study that assigns participants to a tested intervention. The registered 415 participants enrollment target is mid-sized for trials with a published cap, above the 236-participant average among 21 other Brain Injuries, Traumatic trials with a reported enrollment target (76% higher).
The record links to 3 conditions, with Brain Injuries, Traumatic appearing as the primary indexed condition, and to 2 interventions - of which Usual Care is the first listed.
NCT03429322 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT03429322 about?
NCT03429322 is a clinical study titled "Medical and Resource Facilitation Intervention After Traumatic Brain Injury". Mayo Clinic's Traumatic Brain Injury (TBI) Model System Center (TBIMSC) will capitalize on longstanding collaborations with the non-profit Minnesota Brain Injury Alliance (MN BIA) and Minnesota Department of Health (MDH) to test a new way of delivering medical and social services. This trial will ad...
What is the current status of trial NCT03429322?
This trial is currently completed. It is a NA study. The enrollment target is 415 participants. The study started on 2019-01-11. Estimated completion is 2022-12-03.
What conditions does trial NCT03429322 study?
This clinical trial studies the following conditions: Brain Injuries, Traumatic, Family, Physician's Role.
What interventions are being tested in trial NCT03429322?
The interventions under investigation include: Usual Care (OTHER), Medical Care and Resource Facilitation (BEHAVIORAL).
Who is sponsoring clinical trial NCT03429322?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03429322 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03429322's enrollment target sits among peer trials
415 4th of 21 higher than 18 of 21 other Brain Injuries, Traumatic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Brain Injuries, Traumatic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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