Positive Assurance and mTBI

Part of paid clinical trials in Falls Church, Virginia.

Sponsor
Inova Health Care Services
Study ID
NCT04982731
Status
Enrolling By Invitation

Conditions

  • Concussion, Mild Traumatic Brain Injury
  • MTBI - Mild Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
13 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Positive Assurance — OTHER
    Positive assurance is a low-cost, non-pharmacological strategy commonly used by specialty clinics to manage anxiety in individuals with mTBI. Positive assurance is comprised of words of affirmation given to individuals with a medical condition by a healthcare provider that are centered on hope and positive recovery expectations (i.e., "You will recover," "This can be treated").

Study Details

This study will develop and validate a new educational video that provides positive assurance about mild traumatic brain injury (mTBI) recovery for patients with mTBI.

Key Dates

Start date
Oct 15, 2021
Status verified
Oct 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
229 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Positive Assurance Discharge Video Educational Intervention (EDUC).
    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. Participants will be instructed to view the video at least once every 24 - 48 hours prior to their visit to the concussion clinic.
  • No Intervention: Standard of Care Instructions (Treatment as Usual: TAU )
    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, however these participants will not be given a QR code to watch the intervention video.

Primary Outcome Measure

Behavioral Regulation Assessment for Concussion (BRAC) [ Time Frame: Gathered at Baseline Visit ]

Locations (1)

FacilityCityStateZIPSite coordinators
Inova Health SystemFalls ChurchVirginia22042-

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By research site
Inova Health System· Falls Church, VA

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