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临床试验/NCT01890031
NCT01890031已完成1 期

The Interactive Cholesterol Advisory Tool

University of Rochester2 个研究点 分布在 1 个国家目标入组 131 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
131
试验地点
2
主要终点
LDL-C in All ICAT Group Participants Versus Non-ICAT Group Participants

研究概览

简要总结

The purpose of this study is to show that we can effectively deliver health information and education, online, via computer regarding cholesterol. This computer program is called the Interactive Cholesterol Advisory Tool (ICAT).

详细描述

Participants will be recruited and categorized based on screening labs into 1 of 2 groups: Low or moderate risk of developing cardiovascular disease within 10 years based on risk factors. The low risk group will be advised to take the blood test results furnished by the study to their primary care doctor to discuss managing cholesterol. The moderate risk group will see the study physician for 4 visits about high cholesterol. Both groups complete a total of 4 blood draws over 9 months. Both groups will be randomized at consent into 2 groups: 1 who uses the Interactive Cholesterol Advisory Tool (ICAT) and 1 that does not use the ICAT. Because recruitment goals for the low risk group were met, a third group was created: low risk who both the study physician for 4 visits about high cholesterol and use the ICAT.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Fluency in English,
  • Willing to come in for 1-5 visits,
  • Low and moderate CVD risk.
  • Having access to a computer with internet connection

排除标准

  • CVD diagnosis or CVD equivalent,
  • Psychosis, terminal illness,
  • Pregnancy,
  • Current statin use if assigned to the low risk group
  • Liver disease,
  • Peripheral Vascular Disease,
  • Diabetes Mellitus,
  • Abdominal Aortic Aneurism,
  • Cerebral Vascular Disease
  • Triglyceride level above 500 mg/dl
  • Uncorrected hypothyroidism

结局指标

主要结局

LDL-C in All ICAT Group Participants Versus Non-ICAT Group Participants

时间窗: 9 months

次要结局

  • Number of Participants Who Adhered to Medication Prescribed as Self Reported at 9 Months(9 months)

研究者

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

Robert Block

Professor

University of Rochester

研究点 (2)

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