NCT05261477 Brain Injury Education and Outpatient Navigation-1stBIEN
| NCT ID | NCT05261477 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Seattle Children's Hospital |
| Condition | Brain Injuries, Traumatic |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-07-07 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2022-07-07 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Traumatic brain injury (TBI) is a significant problem for U.S. Hispanic children. Compared to non-Hispanic children, Hispanic children have higher long-term disability and lower health related quality of life, even though differences are not present at hospital discharge. Rehabilitation decreases disability, but needs timely initiation, and long treatments in hospitals, community healthcare facilities and schools. Parents play a key role in their child's recovery. Hispanic parents face additional barriers to initiate and maintain outpatient treatments. They report knowledge gaps in TBI-education, community, and school support systems; language and health literacy barriers. The investigators developed, a bilingual bicultural theory-based program for Hispanic families consisting of Brain Injury Education and outpatient care Navigation (1st BIEN). It integrates in-person education enriched by video content delivered through mobile phones, with navigation during transitions to outpatient care and school return. The pilot established feasibility and acceptability of the program. This randomized control trial will determine efficacy to maintain long-term adherence to rehabilitation and reduce disability. It will enroll 150 parent-child dyads: children (6-17 y), with mild-complicated, moderate-severe TBI in 5 centers in Washington, Texas, Dallas, Utah and Oregon and their parents. Intervention group parents receive: One in-person education session, plus bi-weekly videos tailored to the child's TBI and therapies; and, 3-months of bilingual outpatient care navigation. Attention control parents receive one in person-education session, monthly well-child texts and usual institutional follow up care. Primary outcome is treatment adherence at 6 months post-discharge measured by percentage of follow-up appointments attended during the prescribed time at hospitals, and community care facilities. Secondary outcomes are functional status of the child using PROMIS parental report measures; and parental health literacy, self-efficacy, and mental health at 3, 6, and 12 months after discharge. Child's academic performance will be assessed using school records. The study evaluates a flexible and scalable intervention using mobile phones to aid transitions of care, improve treatment adherence and TBI outcomes. It addresses the needs of an understudied population and can serve as a model for TBI family centered care for at risk groups.
Eligibility Criteria
Children Inclusion criteria: 1. Children 3 to 17 years of age, 2. Hispanic ethnicity 3. Diagnosis of mild, moderate or severe TBI. 4. Hospitalization at one of the 5 academic institutions participating in this trial, 5. Treatment requiring at least one type of rehabilitation therapy as outpatient Parent Inclusion Criteria: 1. Hispanic ethnicity 2. Being the primary caregiver for the child (For longitudinal follow-up purposes) Exclusion criteria: Child: 1. Prior neurological deficits, 2. Acquired brain injuries secondary to other conditions different from trauma. 3. Traumatic brain injuries secondary to abusive trauma. Parent: 1. Loss of custody of the child (i.e. abusive head trauma) 2. Inability to be contacted by phone
Contact & Investigator
Nathalia Jimenez, MD, MPH
PRINCIPAL INVESTIGATOR
Seattle Children's Hospital
Frequently Asked Questions
Who can join the NCT05261477 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, studying Brain Injuries, Traumatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05261477 currently recruiting?
Yes, NCT05261477 is actively recruiting participants. Contact the research team at Andrea.Oliva@seattlechildrens.org for enrollment information.
Where is the NCT05261477 trial being conducted?
This trial is being conducted at Colorado Springs, United States, Portland, United States, Dallas, United States, Salt Lake City, United States and 2 additional locations.
Who is sponsoring the NCT05261477 clinical trial?
NCT05261477 is sponsored by Seattle Children's Hospital. The principal investigator is Nathalia Jimenez, MD, MPH at Seattle Children's Hospital. The trial plans to enroll 300 participants.