Positive Assurance and mTBI

N/AEnrolling By InvitationNCT04982731

Inova Health Care Services229 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

229

Conditions

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

Interventions

Positive AssuranceOTHER

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").

Eligibility

Sex: ALLMin age: 13 YearsMax age: 21 Years

Medical Language ↔ Plain English

COHORT 1 (no longer being recruited): INCLUSION CRITERIA: Subjects must meet the following criteria in order to be eligible to participate: 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 remote informed written consent (parent) and assent EXCLUSION CRITERIA: Subjects who meet any of the following criteria will not be eligible to participate: 1. Loss of consciousness \> 30 minutes in conjunction with the injury 2. Glasgow Coma Scale (GCS) score \< 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. COHORT 2: INCLUSION CRITERIA: Subjects must meet the following criteria in order to be eligible to participate: 1. 13-21 years 2. Has scheduled an appointment to be evaluated at the Inova Sports Medicine Concussion Clinic for a traumatic closed head injury that has occurred within the past 30 days 3. The time between study enrollment and the initial clinical visit is at least two days 4. Is able to provide remote informed written consent (parent) and assent EXCLUSION CRITERIA: Subjects who meet any of the following criteria will not be eligible to participate: 1. Loss of consciousness \> 30 minutes in conjunction with the injury 2. Glasgow Coma Scale (GCS) score \< 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. WITHDRAWAL CRITERIA (BOTH COHORTS): 1\. Upon examination, if the clinical team determines that a participant did not sustain/cannot confirm a concussion, the subject will be withdrawn from the study.

Locations (1)

Inova Health System

Falls Church, Virginia, United States

Outcomes

Primary Outcomes

Behavioral Regulation Assessment for Concussion (BRAC)

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.

Time frame: Gathered at Baseline Visit

Expectations of Recovery Scale

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.

Time frame: Gathered at Baseline Visit

Secondary Outcomes

State-Trait Anxiety Inventory (STAI)

The State-Trait Anxiety Inventory (STAI) will be used to assess state anxiety in participants ages 15 years and older. The S-Anxiety scale (STAI Form Y-1) consists of twenty statements that are rated on a four-point Likert scale (1- not at all; 4 - very much so) that evaluate how respondents feel "right now, at this moment." The T-Anxiety scale (STAI Form Y-2) consists of twenty statements rated on a four-point Likert scale (1- almost never; 4 - almost always) that assess how people generally feel. Scores for both scales are continuous and range from 20-80, and clinical levels of state anxiety are classified with scores \>40.

Time frame: Gathered at Baseline Visit and through study completion, an average of one month

mTBI Symptoms

Data from ClinicalTrials.gov

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