Developing and Evaluating a Positive Assurance Intervention on Recovery Outcomes in mTBI Patients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 229
- 试验地点
- 1
- 主要终点
- Behavioral Regulation Assessment for Concussion (BRAC)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 13 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COHORT 1 (no longer being recruited):
- •INCLUSION CRITERIA:
- •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
排除标准
- •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
- •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.
- •INCLUSION CRITERIA:
- •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
- •EXCLUSION CRITERIA:
- •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
- •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.
研究组 & 干预措施
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.
干预措施: Positive Assurance (Other)
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.
结局指标
主要结局
Behavioral Regulation Assessment for Concussion (BRAC)
时间窗: Gathered at Baseline Visit
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
时间窗: Gathered at Baseline Visit
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.
次要结局
- Immediate Post-concussion Assessment and Cognitive Test (ImPACT)(Gathered at Baseline Visit and through study completion, an average of one month)
- Vestibular/Ocular Motor Screening (VOMS)(Gathered at Baseline Visit and through study completion)
- State-Trait Anxiety Inventory (STAI)(Gathered at Baseline Visit and through study completion, an average of one month)
- mTBI Symptoms(Gathered at Baseline Visit and through study completion, an average of one month)
- mTBI Symptoms(Gathered at Baseline Visit and through study completion, an average of one month)
- State-Trait Anxiety Inventory (STAI)(Gathered at Baseline Visit and through study completion, an average of one month)
- Immediate Post-concussion Assessment and Cognitive Test (ImPACT)(Gathered at Baseline Visit and through study completion, an average of one month)
- Vestibular/Ocular Motor Screening (VOMS)(Gathered at Baseline Visit and through study completion)