Clinical trial NCT04982731: Positive Assurance and MTBI
Official title: Developing and Evaluating a Positive Assurance Intervention on Recovery Outcomes in MTBI Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: MTBI - Mild Traumatic Brain Injury
Concussion, Mild Traumatic Brain Injury
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 70
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will develop and validate a new ED/Urgent Care discharge 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 ED/Urgent Care Positive Assurance discharge intervention video on state anxiety and clinical recovery outcomes in pediatric patients with mTBI. A sample of adolescent and young adult patients (13-21yrs) will be recruited for participation that present to the IFH Pediatrics ED (PED) and/or Inova GoHealth Urgent Care sites with confirmed 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).

Eligibility criteria: Inclusion Criteria:

1. 13-21 years
2. 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)
3. Has receive a medical diagnosis of mTBI from an emergency physical at the IFH Pediatrics ED or Inova GoHealth Urgent Care clinic within 72 hours of injury
4. Is able to provide informed written consent (parent) and assent

Exclusion Criteria:

1. Loss of consciousness \&gt; 30 minutes in conjunction with the injury
2. Glasgow Coma Scale (GCS) score \&lt; 13
3. Has sustained a previous mTBI within the past 6 months
4. Has a neurological disorder (e.g., epilepsy)
5. Has a positive finding on brain imaging (e.g., CT, MRI) that suggests a severe closed head or open injury involving any structural damage or abnormality (e.g., fracture, subdural hematoma)
6. Has a previous history of neurosurgery
7. Does not speak English as a primary language
8. Requires admission to the hospital
9. Has developmental delays
10. Prisoner
11. Pregnant\*
12. Has been previously enrolled in the study
13. Members of same household will not be included as they may determine their group assignment if more than one person from same household is included and assigned to different groups.

Primary outcomes:
measure: Behavioral Regulation Assessment for Concussion (BRAC)
timeFrame: Gathered at Baseline Visit
measure: Expectations of Recovery Scale
timeFrame: Gathered at Baseline Visit
Secondary outcomes:
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: Gathered at Baseline Visit and through study completion, an average of one month
measure: mTBI Symptoms
timeFrame: Gathered at Baseline Visit and through study completion, an average of one month
measure: Immediate Post-concussion Assessment and Cognitive Test (ImPACT)
timeFrame: Gathered at Baseline Visit and through study completion, an average of one month
measure: Vestibular/Ocular Motor Screening (VOMS)
timeFrame: Gathered at Baseline Visit and through study completion
Other outcomes:
Locations:
city: Falls Church
country: United States
facility: Inova Health System
state: Virginia
Study officials:
References: