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临床试验/NCT05908240
NCT05908240进行中(未招募)不适用

Prevention of Cardiovascular Disease and Mortality in Patients With Psoriasis or Psoriatic Arthritis: Translating Guidelines of Care to Better Outcomes for Patients With Psoriatic Disease

University of Pennsylvania28 个研究点 分布在 1 个国家目标入组 520 人开始时间: 2023年6月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
520
试验地点
28
主要终点
Change in LDL

研究概览

简要总结

The goal of this research is to test a novel centralized care coordinator program to assist patients with psoriatic disease in lowering their risk of cardiovascular disease through the application of standard of care approaches to improving modifiable cardiovascular risk factors.

详细描述

Psoriasis patients have an increased risk of cardiovascular disease and mortality but are less likely to have traditional cardiovascular risk factors identified or adequately managed. Care coordinators have previously been demonstrated to improve outcomes in patients with chronic diseases (such as comorbid diabetes and depression) and are now routinely embedded in primary care practices in integrated health systems. The goal of this research is to test a novel centralized care coordinator program to assist patients with psoriatic disease in lowering their risk of cardiovascular disease through the application of standard of care approaches to improving modifiable cardiovascular risk factors.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Willing and able to provide informed consent
  • •Male or female aged 40-75
  • •Being seen by a dermatology provider in routine care for the primary encounter diagnosis of psoriasis

排除标准

  • •Currently taking a prescription lipid lowering medication
  • •Pregnant or planning pregnancy in the next 6 months
  • •Has a known history of cardiovascular disease (MI, Stroke, coronary artery, cerebrovascular, or peripheral vascular disease)

研究组 & 干预措施

Care Coordination

Other

干预措施: Care Coordinator Model (Other)

结局指标

主要结局

Change in LDL

时间窗: 6 months

Change in LDL cholesterol

次要结局

  • Smoking status change(6 months)
  • Change in 10-year cardiovascular (CV) risk(6 months)
  • Addition of new medication(6 months)
  • 50% LDL reduction(6 months)
  • Change in blood pressure(6 months)
  • Change in cholesterol(6 months)
  • Change in non-HDL(6 months)
  • Change in Physicians Global Assessment (PGA) psoriasis severity(6 months)
  • 30% LDL reduction(6 months)
  • LDL reduction under 100(6 months)
  • Change in HDL(6 months)
  • Change in HbA1c(6 months)
  • Change in Weight(6 months)
  • Change in general health(6 months)
  • Change in reported psoriasis medication use(6 months)
  • Change in dermatology life quality index (DLQI)(6 months)
  • Change in physical activity level(6 months)
  • Patient experience with Care Coordinator Model(6 months)
  • Percent undergoing additional CV testing(6 months)
  • Change in Body Surface Area (BSA) psoriasis severity(6 months)
  • Change in physical activity days active(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (28)

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