Extending Veteran Participation in the Validation of the SCI-QOL/CAT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 284
- 试验地点
- 2
- 主要终点
- SCI-QoL Independence
研究概览
简要总结
The field of spinal cord injury rehabilitation medicine lacks a reliable, patient reported, health-related quality of life measurement tool. The National Institute of Health has provided funding to develop a spinal cord injury-specific, quality of life survey tool in non-Veterans with spinal cord injury called the spinal cord injury-quality of life (SCI-QOL). This quality of life survey asks questions regarding physical/medical, emotional, and social health as it relates to individuals with spinal cord injury.
The purpose of this study is to include a Veteran population in the making of the quality of life survey. Each participant will be asked to complete a packet of quality of life questions. Participants will be given the opportunity to take the survey a second time, either 7-14 days or 5-7 months after the first survey. Taking the survey twice will allow the research team to test the reliability of the survey. Comparing the SCI-QOL with other legacy measures will allow the investigators to test the validity of the survey.
Additionally, the investigators will be testing the SCI-QOL between Veterans and non-Veterans with SCI to determine if there are differences in their self-reported quality of life.
This study will be recruiting participants at the James J. Peters Veterans Affairs Medical Center, Bronx, New York and the James A. Haley Veterans Affairs Hospital, Tampa, Florida.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female Veterans with traumatic spinal cord injury
- •At least 18 years old
- •Persons judged by their primary care doctor to be competent
- •Able to read
- •Fluent in English.
排除标准
- •Veterans with non-traumatic spinal cord injury ("non-traumatic" is defined as any injury from a chronic condition that resulted in decline of function due to the paralysis. These conditions include, but are not limited to: multiple sclerosis, arteriole-venous malformation, nerve impingement syndromes, congenital birth defects, or other)
- •Diagnosis of a cognitive impairment (in the clinical chart) such that it limit the subject's ability to read, understand, and respond to statements about quality of life
- •Not fluent in English.
结局指标
主要结局
SCI-QoL Independence
时间窗: Baseline
Average score on a questionnaire about level of independence. The minimum score on the scale is 24.6 and the maximum is 68.9. Fifty is the average score. Values below 50 indicate a worse outcome. Values above 50 represent a better outcome.
次要结局
- SCI-QoL Ability to Participate in Social Roles and Activities(Baseline)
- SCI-QoL Satisfaction With Social Roles and Activities(Baseline)
- SCI-QoL Bowel Management Difficulties(Baseline)
- SCI-QoL Depression(Baseline)
- SCI-QoL Pain Behavior(Baseline)
- SCI-QoL Positive Affect and Well-being(Baseline)
- SCI-QoL Anxiety(Baseline)
- SCI-QoL Bladder Management Difficulties(Baseline)
- SCI-QoL Resilience(Baseline)
- SCI-QoL Trauma(Baseline)
- SCI-QoL Pain Interference(Baseline)
- SCI-QoL Stigma(Baseline)