NCT00708370已完成4 期
An Outcome Research on the Impact of a Disease Management Program (COACH) on the Attainment of Better Cardiovascular Risk Control in Dyslipidemic Patients at Primary Care Centers (DISSEMINATE).
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.22 个研究点 分布在 1 个国家目标入组 297 人开始时间: 2008年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 297
- 试验地点
- 22
- 主要终点
- Percentage (%) change from baseline to week 24 in serum LDL-C levels.
研究概览
简要总结
This study is a local PCO sponsored, interventional, non-drug study to evaluate the efficacy of a health tele-counselling program in reducing cardiovascular risk in dyslipidemic patients.
详细描述
Educational / Counseling
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 否
入选标准
- •Subjects who are newly diagnosed with dyslipidemias.
- •Subjects must be lipid drug naive and eligible for statin therapy.
排除标准
- •Subjects who cannot be contacted by telephone or handphone.
- •Subjects with uncontrolled primary hypothyroidism.
研究组 & 干预措施
Standard Care
Placebo Comparator
干预措施: No intervention for placebo (Other)
COACH
Active Comparator
干预措施: COACH (Other)
结局指标
主要结局
Percentage (%) change from baseline to week 24 in serum LDL-C levels.
时间窗: 24 weeks from Baseline
次要结局
- Percentage (%) change from baseline in serum LDL-C (week 36), TC (week 24 and 36), HDL-C (week 24 and 36), TG (week 24 and 36) and TC/HDL-C ratio (week 24 and 36).(24 and 36 weeks from Baseline)
- Absolute change in SBP and DBP from baseline to weeks 24 and 36.(24 and 36 weeks from Baseline)
- Percentage (%) change in Framingham CHD risk score from baseline to weeks 24 and 36.(24 and 36 weeks from Baseline)
- Subjects' lifestyle modification as assessed by the incidence and frequency of smoking, consumption of foods high in salt, sugar and/or fat content, alcohol consumption, and exercise habits at baseline and weeks 24 and 36.(24 and 36 weeks from Baseline)
- Subjects' satisfaction with the Health Booklet and the COACH program after 24 weeks.(24 weeks from Baseline)
研究者
研究点 (22)
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