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Active, Not Recruiting

NCT Number: NCT05908240

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic, Scottsdale, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Care Coordinator Model

Other

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.

Primary outcomes

  1. Change in LDL

    Time frame: 6 months

    Change in LDL cholesterol

Secondary outcomes

  1. Addition of new medication

    Time frame: 6 months

    Percent newly using lipid lowering, hypertension (HTN), or diabetes (DM) medications

  2. Change in 10-year cardiovascular (CV) risk

    Time frame: 6 months

    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.

  3. 30% LDL reduction

    Time frame: 6 months

    Percent with 7.5% to 20% risk who achieve a 30% or greater reduction in LDL on follow up testing

  4. 50% LDL reduction

    Time frame: 6 months

    Percent with greater than or equal to 20% risk who achieve LDL reduction of greater than or equal to 50%

  5. LDL reduction under 100

    Time frame: 6 months

    Percent who achieve LDL less than 100 mg/dL or non-HDL less than 130 mg/dL

  6. Change in blood pressure

    Time frame: 6 months

    Change in systolic blood pressure (mm Hg)

  7. Change in cholesterol

    Time frame: 6 months

    Change in total cholesterol (mg/dL)

  8. Change in HDL

    Time frame: 6 months

    Change in HDL cholesterol (mg/dL)

  9. Change in non-HDL

    Time frame: 6 months

    Change in non-HDL cholesterol (mg/dL)

  10. Change in HbA1c

    Time frame: 6 months

    Change in hemoglobin A1c level measured in percent.

  11. Change in Weight

    Time frame: 6 months

    Change in weight calculated by BMI (kg/m2)

  12. Smoking status change

    Time frame: 6 months

    Percent of patients who quit smoking measured by self-reported response to survey question.

  13. Percent undergoing additional CV testing

    Time frame: 6 months

    Percent undergoing additional cardiovascular (CV) risk testing such as stress test, coronary calcium score or related imaging.

  14. Change in Body Surface Area (BSA) psoriasis severity

    Time frame: 6 months

    Change in percent of body surface area affected by psoriasis will be assessed.

  15. Change in Physicians Global Assessment (PGA) psoriasis severity

    Time frame: 6 months

    Change in PGA score measured from 0-5 with 5 being the most severe psoriasis and 0 being the least severe.

  16. Change in dermatology life quality index (DLQI)

    Time frame: 6 months

    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.

  17. Change in general health

    Time frame: 6 months

    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.

  18. Change in reported psoriasis medication use

    Time frame: 6 months

    Proportion of patients who have reported any change in medications taken for psoriatic disease measured through a patient reported survey.

  19. Change in physical activity days active

    Time frame: 6 months

    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

  20. Change in physical activity level

    Time frame: 6 months

    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.

  21. Patient experience with Care Coordinator Model

    Time frame: 6 months

    Patient experience with the care coordinator will be measured through the Patient Experience Survey with a likert scale from strongly agree to strongly disagree.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Psoriasis Foundation

Registry information

Official study title

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

Acronym: CP3

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2023
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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