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临床试验/NCT02116673
NCT02116673已完成不适用

The Influence of Cognitive Rest and Graduated Return to Usual Activities on Minor Traumatic Brain Injury

Mount Sinai Hospital, Canada2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
Minor traumatic brain injury symptoms

研究概览

简要总结

Background: Head injury is a common presentation to family medicine clinics and emergency departments (EDs), and the majority will not result in intracranial injury requiring neurosurgical consultation, but will have symptoms of mild traumatic brain injury (MTBI). It is estimated between 15-50% of patients with MTBI develop post-concussive syndrome (PCS). Research in the management of MTBI and prevention of PCS has been scarce to date. Although expert consensus recommends cognitive rest and graduated return to usual activities, these and other interventions are not based on prospective clinical evidence.

Objective: The purpose of this study is to determine if providing graduated return to usual activities discharge instructions to MTBI patients in the ED decreases MTBI symptoms post-injury as compared to providing usual ED MTBI discharge instructions.

Study Design: This will be a pragmatic, single-centered, 2-arm parallel-group, superiority randomized trial.

Patient Population: Male and female patients presenting to the ED ages greater than 17 and less than 65 with the Canadian Emergency Department Information System (CEDIS) presenting complaint of "head injury".

Outcomes: The primary outcome of this study is to determine if patients whom receive graduated return to usual activity discharge instructions have more clinically significant decreases in their Post-Concussion Symptom Score (PCSS) 2 weeks after MTBI versus patients who received usual care MTBI discharge instructions. Secondary outcomes include the intervention group's compliance with the intervention, comparison of PCSS between groups 4 weeks after initial ED visit, comparison of groups' number of return visit(s) to either an ED or physician's office, and the mean number of days of school or work missed for each group.

Hypothesis: Given cognitive rest and graduated return to usual activities are concepts recommended by expert consensus, it is expected patients who follow the graduated return to usual activities and cognitive rest guidelines will have less MTBI symptoms at two weeks after ED discharge.

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 (Investigator, Outcomes Assessor)

入排标准

年龄范围
17 Years 至 64 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female patients presenting to the ED with the Canadian Emergency Department Information System (CEDIS) chief complaint of "head injury".
  • Age greater than 17 years and less than 65 years.
  • Injury occurring within the last 24 hours.

排除标准

  • Acute intracranial injury identified on head CT
  • Glasgow Coma Scale (GCS) < 15 at time of discharge
  • Non-English speaking

结局指标

主要结局

Minor traumatic brain injury symptoms

时间窗: 4 weeks

Measured by the Post-concussion Symptom Score (PCSS)

次要结局

  • Visits to the emergency department or other health care professionals(4 weeks)
  • Days of work or school missed(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Catherine Varner

Emergency Physician

Mount Sinai Hospital, Canada

研究点 (2)

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