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Educational Video for Concussion

N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up gathered at baseline visit and through study completion, an average of one month
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Behavioral Regulation Assessment for Concussion (BRAC)
Expectations of Recovery Scale
Secondary outcome measures
Immediate Post-concussion Assessment and Cognitive Test (ImPACT)
State-Trait Anxiety Inventory (STAI)
Vestibular/Ocular Motor Screening (VOMS)
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ED 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 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 Discharge Instructions (Treatment as Usual: TAU )Active Control1 Intervention
The Acute Concussion Evaluation (ACE) Care plan in place at the Inova PED 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.

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Who is running the clinical trial?

Inova Health Care ServicesLead Sponsor
69 Previous Clinical Trials
22,189 Total Patients Enrolled

Media Library

Positive Assurance Clinical Trial Eligibility Overview. Trial Name: NCT04982731 — N/A
Concussion Research Study Groups: Standard of Care ED Discharge Instructions (Treatment as Usual: TAU ), ED Positive Assurance Discharge Video Educational Intervention (EDUC).
Concussion Clinical Trial 2023: Positive Assurance Highlights & Side Effects. Trial Name: NCT04982731 — N/A
Positive Assurance 2023 Treatment Timeline for Medical Study. Trial Name: NCT04982731 — N/A

Frequently Asked Questions

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

What is the scope of participation for this research endeavor?

"Affirmative. According to records hosted on clinicaltrials.gov, the medical research project - which was initially posted October 15th 2021- is actively recruiting participants from a single site and needs 70 individuals overall."

Answered by AI

Is this research endeavor recruiting participants at the present time?

"Affirmative, according to the information presented on clinicaltrials.gov this medical trial is currently enlisting subjects. This research project was first published on October 15th 2021 and was most recently revised in August of 2022. The study requires 70 individuals across one site for its completion."

Answered by AI

Does this research experiment accept participants who are elderly?

"This research initiative is seeking out adolescent participants who are between 13 and 21 years old."

Answered by AI

Who is qualified to be part of this research endeavor?

"This research endeavor is seeking 70 youth aged 13-21 who have recently received a diagnosis of mild traumatic brain injury (mTBI) from an emergency physician at the IFH Pediatrics ED within 72 hours of sustaining external force to their head or body which resulted in neurological symptoms, such as dizziness, confusion, headache, postural instability, light/noise sensitivity, nausea."

Answered by AI

What are the intended discoveries from this research project?

"This medical trial, whose duration will be measured at the initial patient visit, aims to evaluate Behavioral Regulation Assessment for Concussion (BRAC). Secondary objectives include State-Trait Anxiety Inventory (STAI) scoring of state anxiety in participants 15 years and older using a four-point Likert scale; Immediate Post-concussion Assessment and Cognitive Test (ImPACT), which assesses attention, memory recognition, reaction time visual processing speed etc. via computerized tool; Vestibular/Ocular Motor Screening (VOMS) evaluation of vestibular & ocular motor impairment with self reported symptom severities from 0"

Answered by AI

Who else is applying?

What state do they live in?
Virginia
How old are they?
18 - 65
What site did they apply to?
Inova Health System
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Positive Assurance and mTBI
2021. "Positive Assurance and mTBI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04982731.
~8 spots leftby Aug 2024
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