Back to resultsPositive Assurance and mTBI
Primary Purpose
MTBI - Mild Traumatic Brain Injury
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positive Assurance
Sponsored by
About this trial
This is an interventional treatment trial for MTBI - Mild Traumatic Brain Injury
Eligibility Criteria
Inclusion Criteria:
- 13-21 years
- 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)
- Has receive a medical diagnosis of mTBI from an emergency physical at the IFH Pediatrics ED within 72 hours of injury
- Is able to provide informed written consent (parent) and assent
Exclusion Criteria:
- Loss of consciousness > 30 minutes in conjunction with the injury
- Glasgow Coma Scale (GCS) score < 13
- Has sustained a previous mTBI within the past 6 months
- Has a neurological disorder (e.g., epilepsy)
- 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)
- Has a previous history of neurosurgery
- Does not speak English as a primary language
- Requires admission to the hospital
- Has developmental delays
- Prisoner
- Pregnant*
- Has been previously enrolled in the study
Sites / Locations
- Inova Health SystemRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ED Positive Assurance Discharge Video Educational Intervention (EDUC).
Standard of Care ED Discharge Instructions (Treatment as Usual: TAU )
Arm Description
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. In addition to the viewing of the video after ED discharge, all participants will be instructed to view the video at least once every 24 - 48 hours prior to their visit to the concussion clinic.
The Acute Concussion Evaluation (ACE) Care plan in place at the Inova PED 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 as well, however these participants will not be given a QR code to watch the intervention video.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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).
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.
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.
Full Information
NCT ID
NCT04982731
First Posted
April 7, 2021
Last Updated
September 1, 2023
Sponsor
Inova Health Care Services
1. Study Identification
Unique Protocol Identification Number
NCT04982731
Brief Title
Positive Assurance and mTBI
Official Title
Developing and Evaluating a Positive Assurance Intervention on Recovery Outcomes in mTBI Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inova Health Care Services
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MTBI - Mild Traumatic Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ED Positive Assurance Discharge Video Educational Intervention (EDUC).
Arm Type
Experimental
Arm Description
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. In addition to the viewing of the video after ED discharge, all participants will be instructed to view the video at least once every 24 - 48 hours prior to their visit to the concussion clinic.
Arm Title
Standard of Care ED Discharge Instructions (Treatment as Usual: TAU )
Arm Type
No Intervention
Arm Description
The Acute Concussion Evaluation (ACE) Care plan in place at the Inova PED 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 as well, however these participants will not be given a QR code to watch the intervention video.
Intervention Type
Other
Intervention Name(s)
Positive Assurance
Intervention Description
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").
Primary Outcome Measure Information:
Title
Behavioral Regulation Assessment for Concussion (BRAC)
Description
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
Title
Expectations of Recovery Scale
Description
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 Outcome Measure Information:
Title
State-Trait Anxiety Inventory (STAI)
Description
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
Title
mTBI Symptoms
Description
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).
Time Frame
Gathered at Baseline Visit and through study completion, an average of one month
Title
Immediate Post-concussion Assessment and Cognitive Test (ImPACT)
Description
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.
Time Frame
Gathered at Baseline Visit and through study completion, an average of one month
Title
Vestibular/Ocular Motor Screening (VOMS)
Description
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.
Time Frame
Gathered at Baseline Visit and through study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
13-21 years
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)
Has receive a medical diagnosis of mTBI from an emergency physical at the IFH Pediatrics ED within 72 hours of injury
Is able to provide informed written consent (parent) and assent
Exclusion Criteria:
Loss of consciousness > 30 minutes in conjunction with the injury
Glasgow Coma Scale (GCS) score < 13
Has sustained a previous mTBI within the past 6 months
Has a neurological disorder (e.g., epilepsy)
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)
Has a previous history of neurosurgery
Does not speak English as a primary language
Requires admission to the hospital
Has developmental delays
Prisoner
Pregnant*
Has been previously enrolled in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Dollar, BS
Phone
571-472-0474
Email
Christina.Dollar@inova.org
First Name & Middle Initial & Last Name or Official Title & Degree
R.J. Elbin, PhD
Phone
571-472-0462
Email
Robert.Elbin@inova.org
Facility Information:
Facility Name
Inova Health System
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Dollar, BS
Phone
571-472-0474
Email
Christina.Dollar@inova.org
First Name & Middle Initial & Last Name & Degree
R.J. Elbin, PhD
Phone
571-472-0462
Email
Robert.Elbin@inova.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Positive Assurance and mTBI
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