Positive Assurance and mTBI

MTBI - Mild Traumatic Brain Injury Clinical Trial

Official title:

Developing and Evaluating a Positive Assurance Intervention on Recovery Outcomes in mTBI Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04982731
• Other study ID #: U20-05-4050
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2021
• Est. completion date: August 31, 2025

Study information

• Verified date: September 2023
• Source: Inova Health Care Services
• Contact: Christina Dollar, BS
• Phone: 571-472-0474
• Email: Christina.Dollar[@]inova.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

The research team will investigate the effect of this new ED 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) 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 21 Years

Eligibility

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 within 72 hours of injury

4. Is able to provide informed written consent (parent) and assent

Exclusion Criteria:

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Positive Assurance
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").

Locations

Country	Name	City	State
United States	Inova Health System	Falls Church	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Inova Health Care Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Gathered at Baseline Visit
Primary	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.	Gathered at Baseline Visit
Secondary	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.	Gathered at Baseline Visit and through study completion, an average of one month
Secondary	mTBI Symptoms	The Post-Concussion Symptom Scale (PCSS) will be used to assess mTBI symptoms. This measure includes 22 symptoms (e.g., headache, nausea, dizziness, etc…) that are rated by the patient on a seven-point Likert scale (e.g., 0 = mild, 6 = severe). Outcome scores for the PCSS are total number of reported symptoms (0 - 22) and total symptom severity score (0 - 132).	Gathered at Baseline Visit and through study completion, an average of one month
Secondary	Immediate Post-concussion Assessment and Cognitive Test (ImPACT)	Investigators will assess cognitive function using the Immediate Post-concussion Assessment and Cognitive Test (ImPACT) computerized tool. ImPACT assesses attention, visual working memory, verbal recognition memory, reaction time, visual processing speed, numerical sequencing ability, and learning.	Gathered at Baseline Visit and through study completion, an average of one month
Secondary	Vestibular/Ocular Motor Screening (VOMS)	Investigators will use the Vestibular/Ocular Motor Screening (VOMS) tool to assess vestibular and ocular motor impairment via patient-reported symptom provocation. The VOMS consists of the following five components: 1) smooth pursuits, 2) horizontal and vertical saccades, 3) convergence, 4) horizontal and vertical vestibular ocular reflex (VOR) and 5) visual motion sensitivity (VMS). Self-reported symptom severities (0-10) are reported with each of the five components, with higher ratings reflecting greater symptom severity.	Gathered at Baseline Visit and through study completion