Prevention of Cardiovascular Disease and Mortality in Patients With Psoriasis or Psoriatic Arthritis (CP3)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Psoriasis; Psoriatic Arthritis; Psoriatic Conditions
• Intervention / Treatment: Other: Care Coordinator Model

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.

• Study Type: Interventional
• Enrollment (Estimated): 520
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic
  • Arkansas
    • Fort Smith, Arkansas, United States, 72916
      • Johnson Dermatology
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles
    • Santa Ana, California, United States, 92701
      • Southern California Dermatology
  • Connecticut
    • Cromwell, Connecticut, United States, 06416
      • Central Connecticut Dermatology Research
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Indiana
    • Columbus, Indiana, United States, 47201
      • Dawes Fretzin Clinical Research
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research
  • Massachusetts
    • Somerville, Massachusetts, United States, 02145
      • AP Derm Clinical Research LLC
  • Michigan
    • Northville, Michigan, United States, 48167
      • MiSkinCenter
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • University of New Mexico
  • New York
    • Brooklyn, New York, United States, 11203
      • SUNY Downstate
    • Williamsville, New York, United States, 14221
      • Buffalo Medical Group
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • Pennsylvania
    • Bensalem, Pennsylvania, United States, 19020
      • City Dermatology
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia
  • Washington
    • Bellevue, Washington, United States, 98004
      • Bellevue Dermatology Clinic
    • Mill Creek, Washington, United States, 98012
      • Frontier Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Care Coordination

Other: Care Coordinator Model; A centralized care coordinator at the National Psoriasis Foundation will provide evidence-based education regarding a heart healthy lifestyle (i.e., diet, exercise, smoking cessation) and guidance from the American Heart Association/American College of Cardiology regarding management of dyslipidemia and hypertension. This information will be conveyed to a primary care provider of the patient's preference.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in LDL	Change in LDL cholesterol	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Addition of new medication	Percent newly using lipid lowering, hypertension (HTN), or diabetes (DM) medications	6 months
Change in 10-year cardiovascular (CV) risk	Change in predicted 10-year risk of atherosclerotic cardiovascular disease (ASCVD) among patients with baseline 10-year risk greater than or equal to 5% measured by the American College of Cardiology ASCVD risk estimator tool for predicting percent risk for atherosclerotic cardiovascular disease.	6 months
30% LDL reduction	Percent with 7.5% to 20% risk who achieve a 30% or greater reduction in LDL on follow up testing	6 months
50% LDL reduction	Percent with greater than or equal to 20% risk who achieve LDL reduction of greater than or equal to 50%	6 months
LDL reduction under 100	Percent who achieve LDL less than 100 mg/dL or non-HDL less than 130 mg/dL	6 months
Change in blood pressure	Change in systolic blood pressure (mm Hg)	6 months
Change in cholesterol	Change in total cholesterol (mg/dL)	6 months
Change in HDL	Change in HDL cholesterol (mg/dL)	6 months
Change in non-HDL	Change in non-HDL cholesterol (mg/dL)	6 months
Change in HbA1c	Change in hemoglobin A1c level measured in percent.	6 months
Change in Weight	Change in weight calculated by BMI (kg/m2)	6 months
Smoking status change	Percent of patients who quit smoking measured by self-reported response to survey question.	6 months
Percent undergoing additional CV testing	Percent undergoing additional cardiovascular (CV) risk testing such as stress test, coronary calcium score or related imaging.	6 months
Change in Body Surface Area (BSA) psoriasis severity	Change in percent of body surface area affected by psoriasis will be assessed.	6 months
Change in Physicians Global Assessment (PGA) psoriasis severity	Change in PGA score measured from 0-5 with 5 being the most severe psoriasis and 0 being the least severe.	6 months
Change in dermatology life quality index (DLQI)	Patient reported quality of life outcomes will be assessed using DLQI. The DLQI is calculated by summing the score of 10 questions regarding impact of skin condition on daily life resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.	6 months
Change in general health	EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression on a scale ranging from 1 (no health state problem) to 3 (extreme health state problems). The EQ VAS records the patient's self-rated health on a vertical visual analogue scale ranging from 0, worst health state, to 100, best health state. A scoring function is used to assign a value (i.e., EQ-5D™ index score) to self-reported health states from a set of population-based preference weights. For the U.S. general population, the possible EQ-5D index scores range from -0.11 to 1.0 where 0.0 = death and 1.0 = perfect health.	6 months
Change in reported psoriasis medication use	Proportion of patients who have reported any change in medications taken for psoriatic disease measured through a patient reported survey.	6 months
Change in physical activity days active	Change in patient reported physcial activity level through the Physical Activity Questionnaire measuring the number of days active for at least 30 minutes over the past month	6 months
Change in physical activity level	Change in patient reported physcial activity level through the Physical Activity Questionnaire measuring the patient reported level of physical activity on a likert scale from seldom active to vigorously active.	6 months
Patient experience with Care Coordinator Model	Patient experience with the care coordinator will be measured through the Patient Experience Survey with a likert scale from strongly agree to strongly disagree.	6 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Psoriasis Foundation

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: May 25, 2023
• First Submitted That Met QC Criteria: June 7, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Spinal Diseases; Spondylarthropathies; Skin Diseases, Papulosquamous; Skin Diseases; Spondylarthritis; Spondylitis; Skin and Connective Tissue Diseases; Cardiovascular Diseases; Psoriasis; Arthritis, Psoriatic
• Other Study ID Numbers: 853218

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No