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Clinical Trials/NCT05908240
NCT05908240
Recruiting
Not Applicable

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 Pennsylvania9 sites in 1 country520 target enrollmentJune 15, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Psoriasis
Sponsor
University of Pennsylvania
Enrollment
520
Locations
9
Primary Endpoint
Change in LDL
Status
Recruiting
Last Updated
6 months ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 15, 2023
End Date
July 1, 2026
Last Updated
6 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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)

Outcomes

Primary Outcomes

Change in LDL

Time Frame: 6 months

Change in LDL cholesterol

Secondary Outcomes

  • 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)
  • Change in Weight(6 months)
  • 30% LDL reduction(6 months)
  • LDL reduction under 100(6 months)
  • Change in HDL(6 months)
  • Change in HbA1c(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)
  • Change in dermatology life quality index (DLQI)(6 months)
  • Change in physical activity level(6 months)
  • Patient experience with Care Coordinator Model(6 months)
  • Change in general health(6 months)
  • Change in reported psoriasis medication use(6 months)

Study Sites (9)

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