SCI-CARE (Northwest Regional Spinal Cord Injury Site Specific Project)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 174
- 主要终点
- Change in Quality of Life
研究概览
简要总结
The objective of this study is to test the effectiveness of a collaborative care approach to improving outpatient treatment for inactivity, chronic pain and depression as a way of improving overall Quality of Life for patients with SCI.
详细描述
Individuals with SCI were treated by a care manager who worked in collaboration with the participant's physician to decrease pain, decrease depression symptoms, and/or to increase physical activity. This was done by collaborating on current treatments to make sure that they are being as effective as possible and by providing non-pharmacological treatments.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •diagnosis of traumatic spinal cord injury by medical record review
- •receives primary SCI care from a provider at the University of Washington or Harborview Medical Center's Rehabilitation Outpatient Clinic
- •positive screening for pain related to SCI diagnosis and/or
- •positive screening for low mood and/or
- •negative screening for physical activity levels
- •able to speak and understand English
排除标准
- •psychiatric condition that would interfere with participation
- •major surgery in the next 8 months
研究组 & 干预措施
Usual Care
No intervention, usual care
Intervention
Collaborative care with Health Care Assistant
干预措施: Collaborative Care (Behavioral)
结局指标
主要结局
Change in Quality of Life
时间窗: Baseline, 4 months
Quality of Life is assessed via telephone interviews at baseline and 4 months.
次要结局
- Change in Physical Activity(Baseline, 4 months, 8 months)
- Change in Mood(Baseline, 4 months, 8 months.)
- Change in Quality of Life(Baseline, 8 months)
- Adverse events(baseline to 4 months)
- Change in Pain(Baseline, 4 months, 8 months)
研究者
Charles Bombardier
Professor, Rehabilitation Medicine
University of Washington