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Brain Injury Education and Navigation for Traumatic Brain Injury (1st-BIEN Trial)

N/A

Recruiting

Led By Nathalia Jimenez, MD, MPH

Research Sponsored by Seattle Children's Hospital

Eligibility Criteria Checklist

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

Must have

Treatment requiring at least one type of rehabilitation therapy as outpatient

Diagnosis of mild-complicated, moderate or severe TBI

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year before the injury and 1 year after the injury

Awards & highlights

1st-BIEN Trial Summary

This trial will determine the efficacy of a bilingual bicultural program to help Hispanic families with a child who has suffered a traumatic brain injury. The program includes education and navigation to outpatient care and school return.

Who is the study for?

This trial is for Hispanic children aged 6-17 with mild to severe traumatic brain injury (TBI) who have been hospitalized for over 24 hours and need outpatient rehab therapy. It's also for their primary caregivers, who will help with the child's recovery.Check my eligibility

What is being tested?

The study tests a bilingual program called '1st BIEN' that combines in-person education and mobile video content with navigation support during transitions to outpatient care and school return, aiming to improve long-term adherence to rehabilitation.See study design

What are the potential side effects?

Since this intervention involves educational and navigational support rather than medical treatment, there are no direct side effects like those associated with medications or surgical procedures.

1st-BIEN Trial Eligibility Criteria

Inclusion Criteria

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

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I need outpatient rehabilitation therapy.

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I have been diagnosed with a traumatic brain injury that is not mild.

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I am between 6 and 17 years old.

1st-BIEN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year before the injury and 1 year after the injury

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year before the injury and 1 year after the injury

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year before the injury and 1 year after the injury for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Child's Health Related Quality of Life

Receipt of follow-up care in centralized Hospital and community

Secondary outcome measures

Child's Academic Performance

Child's Anxiety symptoms

Child's Communication

+9 more

Other outcome measures

Caregiver Community Self Efficacy (COMSE)

Caregiver Self efficacy

Engagement with video education materials

+4 more

1st-BIEN Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention groupExperimental Treatment1 Intervention

Intervention group receives one in person education session using the 1stBIEN booklet, video education via mobile phones and care coordination from a bilingual Patient Navigator-PN for 3-months. PN follow up patients weekly for the first month and once a month for two months. Video education is done weekly. Videos cover problem solving training, brain injury concepts, rehabilitation treatments and school resources individualized to patient and family needs. PNs facilitate transition to outpatient care, follow-up with specialists and primary care providers; use of community resources; and communication with teachers and school administrators. PN provides observational and experiential learning opportunities for parents, using three way calls for scheduling of services and interactions with clinics and schools. PN calls use a problem-solving training format, to reinforce parental experiential learning and improve self-efficacy. Expert MD providers (Co-investigators) will supervise PNs.

Group II: Attention Control groupActive Control1 Intervention

Attention Control group receives one in person education session using the 1stBIEN booklet, monthly well-child texts and usual post-injury care including routine follow-up by specialists and primary care providers, per guidelines at each recruiting institution. Control patients have access to a list of community resources included in the 1stBIEN booklet. While education using the 1stBIEN booklet is not part of the current usual care at participating institutions, providing all families with initial education at the time of discharge addresses ethical and practical considerations. It standardizes discharge processes at participating institutions while delineating differences in the intensity of education and care coordination activities.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor

302 Previous Clinical Trials

5,216,707 Total Patients Enrolled

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,964 Previous Clinical Trials

2,674,430 Total Patients Enrolled

Nathalia Jimenez, MD, MPHPrincipal InvestigatorSeattle Children's

Media Library

Bilingual Brain Injury Education and outpatient Navigation for Hispanic families Clinical Trial Eligibility Overview. Trial Name: NCT05261477 — N/A

Traumatic Brain Injury Research Study Groups: Attention Control group, Intervention group

Traumatic Brain Injury Clinical Trial 2023: Bilingual Brain Injury Education and outpatient Navigation for Hispanic families Highlights & Side Effects. Trial Name: NCT05261477 — N/A

Bilingual Brain Injury Education and outpatient Navigation for Hispanic families 2023 Treatment Timeline for Medical Study. Trial Name: NCT05261477 — N/A

Frequently Asked Questions

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

How many participants are engaged in this research endeavor?

"Affirmative. Clinicaltrials.gov states that the trial, which was initially advertised on July 7th 2022, is actively recruiting patients. At present, 300 participants are being sought from 5 distinct medical centres."

Answered by AI

What aims is this medical experiment seeking to achieve?

"Over a period of 6 months following discharge, the primary purpose of this medical study is to assess Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Child's Health Related Quality of Life. Secondary objectives focus on evaluating whether patients have received school support programs such as Individualized Education Programs (IEPs) and 504 accommodation plans; tracking changes in mobility via PROMIS parent proxy v2.0 SF8a; and examining physical upper extremity function with PROMIS parent proxy SF8a. Scores are given according to a five point scale compared against an average population mean score of 50 standard deviation 10"

Answered by AI

How geographically dispersed is the access to this clinical research?

"Patients can enroll in this study at multiple sites, including the University of Utah in Salt Lake City, Seattle Children's Hospital in Seattle, and Harborview Medical Center - University of Washington in Dallas. Additionally, there are 5 other locations available for enrollment."

Answered by AI

Is recruitment for this study ongoing?

"Affirmative. The clinical trial database on clinicialtrials.gov indicates that the study, initially posted on July 7th 2022, is still enrolling patients. 300 participants are needed from 5 locations for completion of this research project."

Answered by AI

Recent research and studies

Journal of Head Trauma RehabilitationJournal

Feasibility and Acceptability of a Telephone-based Intervention for Hispanic Children to Promote Treatment Adherence After Traumatic Brain Injury

Jimenez, Nathalia, Molly Fuentes, Alyssa Virtue, Laura Alonso-Gonzalez, Edgar Lopez, Chuan Zhou, Deborah Crawley, Susan Apkon, Brian Johnston, and Frederick Rivara. 2021. “Feasibility and Acceptability of a Telephone-based Intervention for Hispanic Children to Promote Treatment Adherence After Traumatic Brain Injury”. Journal of Head Trauma Rehabilitation. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/htr.0000000000000658.

clinicaltrials.govStudy

Brain Injury Education and Outpatient Navigation-1stBIEN

Nathalia Jimenez MD, MPH 2022. "Brain Injury Education and Outpatient Navigation-1stBIEN". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05261477.

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