Positive Assurance and mTBI

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Другое 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").

Первичные конечные точки

• Behavioral Regulation Assessment for Concussion (BRAC) [Срок оценки: Gathered at Baseline Visit]
• Expectations of Recovery Scale [Срок оценки: Gathered at Baseline Visit]

Вторичные конечные точки (4)

• State-Trait Anxiety Inventory (STAI) [Срок оценки: Gathered at Baseline Visit and through study completion, an average of one month]
• mTBI Symptoms [Срок оценки: Gathered at Baseline Visit and through study completion, an average of one month]
• Immediate Post-concussion Assessment and Cognitive Test (ImPACT) [Срок оценки: Gathered at Baseline Visit and through study completion, an average of one month]
• Vestibular/Ocular Motor Screening (VOMS) [Срок оценки: Gathered at Baseline Visit and through study completion]

Критерии участия

COHORT 1 (no longer being recruited):

Критерии включения

Subjects must meet the following criteria in order to be eligible to participate:

• 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 or Inova-GoHealth Urgent Care clinic within 72 hours of injury
• Is able to provide remote informed written consent (parent) and assent

Критерии исключения

Subjects who meet any of the following criteria will not be eligible to participate:

• 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
• 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:

Критерии включения

Subjects must meet the following criteria in order to be eligible to participate:

• 13-21 years
• 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
• The time between study enrollment and the initial clinical visit is at least two days
• Is able to provide remote informed written consent (parent) and assent

Критерии исключения

Subjects who meet any of the following criteria will not be eligible to participate:

• 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
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Inova Health System — Falls Church

Идентификаторы

NCT: NCT04982731 · U20-05-4050

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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