What side effects are associated with this type of intervention?

Rehabilitation treatments similar to those studied in the 1st BIEN trial, which include bilingual bicultural education and navigation programs, generally have minimal physical side effects. However, patients and caregivers may experience psychological or emotional stress due to the demands of adhering to a structured program. Additionally, there may be challenges related to the accessibility and consistency of care, especially in underserved populations. Overall, these interventions are designed to support recovery and improve outcomes with a low risk of adverse effects.

What prior FDA approvals exist?

FDA approvals in the field of rehabilitation have primarily focused on medications and therapies that aid in recovery and improve functional outcomes. For instance, intravenous thrombolytic therapy has shown beneficial effects in stroke rehabilitation. Additionally, various pharmacologic treatments, such as antidepressants, have been explored to manage associated conditions like depression, which can impact rehabilitation outcomes. While specific FDA-approved interventions directly mirroring the bilingual, bicultural education and navigation approach of the 1st BIEN trial are not detailed, the emphasis on comprehensive rehabilitation programs and timely initiation of treatments is well-supported in the broader context of rehabilitation medicine.

What other types of research exist?

Promising alternatives to the 1st BIEN program for TBI rehabilitation patients in 2024 include: 1) Telemedicine-based rehabilitation programs that offer remote monitoring and personalized care plans, 2) Virtual reality (VR) and augmented reality (AR) therapies for cognitive and physical rehabilitation, 3) Mobile health (mHealth) applications providing tailored rehabilitation exercises and progress tracking, 4) Multidisciplinary care models integrating speech, occupational, and physical therapy with psychological support, and 5) Community-based rehabilitation programs with strong family involvement and support systems.

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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

Must not have

Child: Acquired brain injuries secondary to other conditions different from trauma

Parent: Inability to be contacted by phone

Timeline

Screening 3 weeks

Treatment Varies

Follow Up ongoing tracking (from enrollment - 12 months follow-up)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a bilingual program called 1st BIEN for Hispanic children with traumatic brain injuries. The program includes education through videos and in-person sessions, plus support to help families access outpatient care. It aims to improve treatment adherence and reduce long-term disability.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My child has a brain injury not caused by physical trauma.

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I, as a parent, cannot be reached by phone.

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My child has a brain injury from abuse.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Child's Health Related Quality of Life

Receipt of follow-up care in centralized Hospital and community

Secondary study objectives

Child's Academic Performance

Child's Anxiety symptoms

Child's Communication

+9 more

Other study objectives

Caregiver Community Self Efficacy (COMSE)

Caregiver Self efficacy

Engagement with video education materials

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common rehabilitation treatments, such as those in the 1st BIEN program, work through education, navigation, and adherence support. Education empowers patients and families with knowledge about the condition and treatment importance. Navigation ensures coordinated care across various settings, facilitating timely interventions. Adherence support, through regular follow-ups and tailored communication, maintains patient engagement in the rehabilitation process. These mechanisms collectively improve functional outcomes and reduce long-term disability in rehabilitation patients.

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