Positive Assurance and mTBI

Browse trials for

• Brain Concussion 530

Brain Concussion

530 studies on the registry are indexed under Brain Concussion; 151 are open to participants now.

This study's planned enrollment of 229 is above the median of 64 across 364 interventional studies indexed under Brain Concussion.

Lead sponsor

Inova Health Care Services is the lead sponsor of 84 studies on the registry; 20 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.

Eligibility criteria

Study arms

• Experimental
  Positive Assurance Discharge Video Educational Intervention (EDUC).

  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. Participants will be instructed to view the video at least once every 24 - 48 hours prior to their visit to the concussion clinic.

  Other: Positive Assurance

• No intervention
  Standard of Care Instructions (Treatment as Usual: TAU )

  The Acute Concussion Evaluation (ACE) Care plan in place at the Inova PED/GoHealth Urgent Care sites 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, however these participants will not be given a QR code to watch the intervention video.

Interventions

• OtherPositive 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").

Primary outcomes

1. 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

2. 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

1. 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

2. 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).

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

3. 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.

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

4. 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.

   Time frame: Gathered at Baseline Visit and through study completion

Individual participant data

Plan to share: No