The Effect of Scheduled Telephone Intervention on Outcomes After Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 433
- 试验地点
- 6
- 主要终点
- A composite measure based on the measures of functional level, emotional status, community activities, and perceived quality of well-being.
研究概览
简要总结
This study seeks to determine if telephone counseling improves the outcome for persons with moderate to severe traumatic brain injury (TBI).
详细描述
Subjects are recruited from the three participating TBI Model Systems of Care at Seattle, Philadelphia, and Jackson. After informed consent is obtained, some information is gathered about the injury and information about how the subject is doing cognitively, socially, and emotionally. After this information is obtained and after the subject is discharged from the acute rehabilitation unit, the subject is randomly selected to receive either standard care after discharge or standard care plus the telephone counseling.
The telephone follow-up group receives a telephone call from a research coordinator in 3-4 days, 2, 4, 8 weeks, and 5, 7, 9, 12, 15, 18, and 21 months after the date of injury. The research coordinator will work with the subject on problem-solving and self-management skills. In addition, the research coordinator will check in with a family member or friend for whom the subject has given permission to speak.
An outcome assessment is done by telephone at 12 months and 24 months after injury.
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a primary diagnosis of traumatic brain injury upon admission to inpatient rehabilitation
- •age 16 years or older
- •arrival to an emergency department within 24 hours of acute injury
- •receipt of both acute hospital care and inpatient rehabilitation within our facilities
- •a permanent home address
排除标准
- •previous hospitalization for TBI
- •acute psychiatric disorder (e.g., schizophrenia or bipolar affective disorder)
- •progressive neurological disease
- •lack of a permanent home address
- •discharge to a skilled nursing facility
研究组 & 干预措施
1
Scheduled telephone counseling over 2 years time.
干预措施: Self-management telephone counseling (Behavioral)
2
This control group will receive standard care after hospital rehabilitation discharge as directed by their physician.
结局指标
主要结局
A composite measure based on the measures of functional level, emotional status, community activities, and perceived quality of well-being.
时间窗: One and two years
次要结局
未报告次要终点