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
- 2
- 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
- 未提供
排除标准
- 未提供
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)
- 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)
- 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)