Telephone Based Management of Hyperlipidemia Utilizing a Self Monitoring Testing Device
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- LDL Level Change From Baseline
研究概览
简要总结
The purpose of the study is to demonstrate that systematic self measurement of blood lipids reduces LDL cholesterol more effectively than standard care. The hypothesis is that cholesterol lowering medication adherence will be improved with self monitoring and reporting of frequent blood lipids and the percentage of patients achieving LDL goal will be greater than without home monitoring.
详细描述
The study utilizes a telephone reporting system to self report lipid values and provide educational counseling regarding lifestyle modification methods to reduce cardiovascular risk. Study patients will be randomized to receive a home monitoring device and will be instructed on its use. Generic simvastatin will be given to reduce LDL levels in all groups. It is the hypothesis that those study patients receiving a home device will reach target LDL (goal LDL) more frequently than those randomized to usual care( no device).
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LDL > 130mg/dl
排除标准
- •Pregnant patients
- •liver disease
- •allergic reaction to statins
研究组 & 干预措施
No self monitoring device
Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided
Self Monitoring Lipid Analyzer
Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.
干预措施: Self Monitoring Lipid Analyzer (Device)
结局指标
主要结局
LDL Level Change From Baseline
时间窗: baseline to 6 months
Comparison of serum LDL level between control and intervention subjects
次要结局
- Medication Compliance(6 months)
- LDL Values at Two Week Interval(6 weeks)
研究者
Alfred A Bove, MD, PhD
Emeritus Professor of Medicine
Temple University