Written Versus Verbal Education for Mild Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Presence of Postconcussional Syndrome
研究概览
简要总结
Mild traumatic brain injury (MTBI) is a common injury that involves loss of consciousness or alteration in mental status induced by an external mechanical force to the head. Education about symptoms and reassurance of a prompt recovery usually results in full recovery. However, a subgroup appears to have persistent symptoms and disability. This study will recruit MTBI patients from two Emergency Departments with the aim of identifying modifiable patient characteristics that can delay or prevent full recovery. A secondary aim is to determine if providing education in writing or in-person makes a difference.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmation of a likely concussion without hospital admission
- •Participants live locally with a fixed address
- •Participants experience at least one new symptom
排除标准
- •Participants who cannot understand/read English
研究组 & 干预措施
Verbal Education
干预措施: Verbal education module (Other)
Written Education
干预措施: Educational Brochure (Other)
结局指标
主要结局
Presence of Postconcussional Syndrome
时间窗: 3 Months
The primary outcome is the presence of Postconcussion Syndrome, defined as 3+ symptoms endorsed as "mild" or greater on the Rivermead Postconcussion Symptom Questionnaire.
次要结局
- Glasgow Outcome Scale-Extended (GOS-E)(3 Months)
- Patient Health Questionnaire-9 (PHQ-9)(3 Months)
- PTSD Checklist-Civilian version (PCL-C)(3 Months)
研究者
Noah Silverberg
Principal Investigator
University of British Columbia