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临床试验/NCT00483444
NCT00483444已完成不适用

The Effect of Telephone Follow-Up on Outcome After Mild TBI

University of Washington2 个研究点 分布在 1 个国家目标入组 366 人开始时间: 2003年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
366
试验地点
2
主要终点
Measure: two composite measures - post-traumatic symptoms that develop or worsen after the injury - general health status

研究概览

简要总结

The purpose of this study is to see whether providing education and counseling after a mild traumatic brain injury will help in preventing symptoms from becoming chronic over the first six months after injury.

详细描述

This study examines the effect of scheduled telephone calls on the outcome after mild traumatic brain injury (MTBI) or concussion. These calls offer subjects information, focused counseling, and referrals. MTBI is extremely common in the United States, numbering well over a million cases per year. Although recovery for most is quite good, 10-20% of persons have persisting symptoms that affect employment, quality of life, and health care expenses. We are examining one means to decrease persisting symptoms by offering early, consistent intervention before symptoms become persistent.

The subjects are enrolled in the emergency departments (ED) of the hospital and receive the baseline assessment while still in the ED. Subjects are randomly assigned to two groups: Group 1 standard care and Group 2 standard care, toll-free telephone number, and scheduled telephone calls for follow-up at 1-2 days, 2, 4, 8, and 12 weeks after injury. All subjects are contacted again at 6 months for an outcome assessment that is done over the telephone.

On the telephone, subjects are asked about current problems, and are given both information about recovery from MTBI and some counseling on dealing with symptoms or other complaints. They are also given community resources to obtain assistance if needed. Telephone call are reviewed by supervisors (physician and psychologist) for adherence to protocol and for training purposes.

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
Single (Outcomes Assessor)

入排标准

年龄范围
16 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis consistent with mild traumatic brain injury
  • Glasgow Coma Scale score 13-15
  • Loss of consciousness less than or = to 30 minutes
  • Any period of alteration of consciousness or post-traumatic amnesia
  • age between 16 and 80
  • permanent address
  • ability to communicate in English

排除标准

  • hospitalization within previous year for traumatic brain injury
  • prior or current diagnosis of central nervous system or major psychiatric disorder
  • Intoxication sufficient enough to cloud the diagnosis of mild TBI
  • current alcohol dependence

研究组 & 干预措施

2

No Intervention

Control group were recruited in the emergency department after concussion and received standard care as directed by the ED physician and PCP.

1

Experimental

Persons with concussion recruited in the emergency department received 5-6 scheduled telephone counseling calls focused on symptom management and self-management.

干预措施: Scheduled telephone follow-up (Behavioral)

结局指标

主要结局

Measure: two composite measures - post-traumatic symptoms that develop or worsen after the injury - general health status

时间窗: Six months

次要结局

  • 1. Improvement of functional level, emotional status, community activities, and perceived quality of life (SF-12 Health Survey, Patient Health Questionnaire - Depression and Anxiety Scales, Community Integration Scale, Perceived Quality of Life)(Six months)
  • Assess the effectiveness of this intervention in subgroups defined by gender or race.(Six months)

研究者

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

Kathleen Bell

Professor, Rehabilitative Medicine

University of Washington

研究点 (2)

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