A Spinal Cord Injury (SCI) Stakeholder-vetted Education Module to Mitigate Early Cardioendocrine Health Risks Occurring After Spinal Cord Injuries.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 9
- 主要终点
- Change in Effectiveness of education modules as determined in the Knowledge Test
研究概览
简要总结
The purpose of this study is to find out if receiving education regarding increased risks of cardiometabolic disease helps subjects understand these risks and how these risks participants' health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and Women with SCI/D aged 18-70 years.
- •Neurologically complete and incomplete American Spinal Injury Association (ASIA) Impairment scale (AIS) A-D spinal cord levels C5 and below.
- •Enrolled no later than 4 months following discharge from initial rehabilitation from SCI.
排除标准
- •Pregnancy determined by urine testing in sexually active females.
- •Cognitive impairment that compromises the legitimacy of consent.
- •Grade 3-4 pressure injury at the time of study entry.
研究组 & 干预措施
WebMD Group
Subjects will be introduced to WebMD and its contents. A brief document will be provided that includes site summary and website. Study staff will provide a very brief overview of the site. Participants will be in this group for 6 months.
干预措施: WebMD (Behavioral)
Paralyzed Veterans of America (PVA) Cardio-Metabolic Disease (CMD) Consumer Guide Group
Hard paper copy of as well as an electronic copy of the guide will be provided to subjects and study staff will provide a general review of the contents of the guide with subjects during their education sessions. Participants will be in this group for 6 months.
干预措施: PVA Consumer Guide (Behavioral)
结局指标
主要结局
Change in Effectiveness of education modules as determined in the Knowledge Test
时间窗: baseline, up to 6 months
Effectiveness as determined by the number of correct answers on the Knowledge Test where the higher number of correct answers indicates increased knowledge of the information provided.
次要结局
- Change in Quality of Life (QoL) as measured by Quality Index Spinal Cord Injury Version III(baseline, up to 6 months)
- Change in heart disease risk as determined by blood pressure (BP)(baseline, up to 6 months.)
- Change in Body Weight as determined by kilograms (kg)(baseline, up to 6 months)
- Change in Quality of Life (QoL) Using the International Spinal Cord Injury Basic Data Set(baseline, up to 6 months)
- Change in sugar metabolism as determined by Insulin resistance (IR)(baseline, up to 6 months)
- Change in Body composition as determined by Dual X-ray Absorptiometry (DXA)(baseline, up to 6 months)
- Change in Body composition as determined by Dual X-ray Absorptiometry (DXA) in Percentage(baseline, up to 6 months)
- Change in heart disease risk as determined by cholesterol(baseline, up to 6 months.)
研究者
Gary Farkas
Principal Investigator
University of Miami