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Educational Video for Concussion

N/A

Waitlist Available

Research Sponsored by Inova Health Care Services

Eligibility Criteria Checklist

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

Must have

Has sustained an external force to head or body resulting in neurological symptoms and at least one reported symptom is attributed to the mTBI (e.g., dizziness, confusion, headache, postural instability, light/noise sensitivity, nausea)

13-21 years of age

Must not have

Requires admission to the hospital

Has a previous history of neurosurgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up gathered at baseline visit and through study completion, an average of one month

Awards & highlights

No Placebo-Only Group

Summary

This trial will develop an educational video to provide assurance to patients with mild traumatic brain injury that they will recover.

Who is the study for?

This trial is for young individuals aged 13-21 who have recently experienced a mild traumatic brain injury (mTBI) with symptoms like dizziness or headaches. They must be diagnosed by an emergency physician within 72 hours of the injury and can't have had a severe mTBI, previous neurosurgery, neurological disorders, or significant findings on brain scans.

What is being tested?

The study is testing an educational video that provides positive assurance about recovery from mTBI. The goal is to develop and validate this video as part of the discharge process for patients treated in the emergency department.

What are the potential side effects?

Since this intervention involves an educational video, there are no direct medical side effects associated with it. However, participants may experience varying psychological impacts based on their individual responses to the information provided.

Eligibility Criteria

Inclusion Criteria

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

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I have had a head or body injury causing symptoms like dizziness or headaches.

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I am between 13 and 21 years old.

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I am between 13 and 21 years old.

Exclusion Criteria

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

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I need to be admitted to the hospital.

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I have had brain surgery in the past.

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I have had a severe head injury confirmed by a brain scan.

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I have a neurological condition like epilepsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ gathered at baseline visit and through study completion, an average of one month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~gathered at baseline visit and through study completion, an average of one month

This trial's timeline: 3 weeks for screening, Varies for treatment, and gathered at baseline visit and through study completion, an average of one month for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Behavioral Regulation Assessment for Concussion (BRAC)

Expectations of Recovery Scale

Secondary study objectives

Immediate Post-concussion Assessment and Cognitive Test (ImPACT)

State-Trait Anxiety Inventory (STAI)

Vestibular/Ocular Motor Screening (VOMS)

+1 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: ED/Urgent Care Positive Assurance Discharge Video Educational Intervention (EDUC).Experimental Treatment1 Intervention

The video intervention will be administered to participants that are randomly assigned to the EDUC group. In addition, current standard of care discharge instructions will also be provided to the participant. This EDUC intervention will consist of a brief, three to five-minute informative video message from the clinical neuropsychologist at the Inova Sports Medicine Concussion Program. In addition to the viewing of the video after ED/Urgent Care discharge, all participants will be instructed to view the video at least once every 24 - 48 hours prior to their visit to the concussion clinic.

Group II: Standard of Care ED/Urgent Care Discharge Instructions (Treatment as Usual: TAU )Active Control1 Intervention

The Acute Concussion Evaluation (ACE) Care plan in place at the Inova PED/GoHealth Urgent Care sites is the standard-of-care discharge instruction for individuals with mTBI. This care plan provides patient and caregiver education about mTBI and emphasizes the monitoring of symptoms, signs of deterioration that may warrant urgent medical attention, and encourages the patient to follow up with their physician for follow up. Participants who are randomized into the TAU group will receive this standard of care treatment in video format as well, however these participants will not be given a QR code to watch the intervention video.

0 / 7Eligibility criteria met