Developing and Evaluating a Positive Assurance Intervention on Recovery Outcomes in mTBI Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- MTBI - Mild Traumatic Brain Injury
- Sponsor
- Inova Health Care Services
- Enrollment
- 229
- Locations
- 1
- Primary Endpoint
- Behavioral Regulation Assessment for Concussion (BRAC)
- Status
- Enrolling By Invitation
- Last Updated
- 6 months ago
Overview
Brief Summary
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.
Detailed Description
The research team will investigate the effect of this new Positive Assurance discharge intervention video on state anxiety and clinical recovery outcomes in patients with mTBI. A sample of adolescent and young adult patients (13-21yrs) will be recruited for participation that present with a potential mTBI diagnosis and receive specialty referral to the Inova Sports Medicine Concussion Program for follow-up care. Investigators will employ a randomized controlled trial (RCT) to enroll two groups of mTBI patients: 1) a group that receives the video intervention (EDUC), and 2) a group that receives standard discharge instructions (i.e., treatment as usual: TAU).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Behavioral Regulation Assessment for Concussion (BRAC)
Time Frame: Gathered at Baseline Visit
The Behavioral Regulation Assessment for Concussion (BRAC) is a five-item, four-point Likert scale (with values ranging from '0-Never' to '5-Most of the Time') assessment for the frequency of self-reported behavioral regulation behaviors that occurred during the past seven days. Scores range from 0 to 20, with higher scores indicating a better outcome. Likert scale scores are reported for each item, with a higher score indicating greater frequency. An average score for the BRAC is the average of all the scores across the items.
Expectations of Recovery Scale
Time Frame: Gathered at Baseline Visit
The Expectations of Recovery Scale will be used to measure the effect of positive assurance on recovery. This is a seven-item scale that asks individuals to assess whether they think they will get better soon, return to usual activities/work within the next month, return to the pre-injury performance and to consider what they had been told about their injury and what those closest to them advised. Items within this scale are scored independently of each other, therefore neither higher nor lower scores indicate a better or worse outcome.
Secondary Outcomes
- State-Trait Anxiety Inventory (STAI)(Gathered at Baseline Visit and through study completion, an average of one month)
- mTBI Symptoms(Gathered at Baseline Visit and through study completion, an average of one month)
- Immediate Post-concussion Assessment and Cognitive Test (ImPACT)(Gathered at Baseline Visit and through study completion, an average of one month)
- Vestibular/Ocular Motor Screening (VOMS)(Gathered at Baseline Visit and through study completion)