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

Cardiovascular Diseases Clinical Trial

— CP3  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05908240
• Other study ID #: 853218
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: October 2025

Study information

• Verified date: July 2023
• Source: University of Pennsylvania
• Contact: Brooke Bishop, MPH
• Phone: 267-581-9714
• Email: Brooke.Bishop[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 520
• Est. completion date: October 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Cardiovascular Diseases
• Psoriasis
• Psoriatic Arthritis

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Psoriasis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in LDL	Change in LDL cholesterol	6 months
Secondary	Addition of new medication	Percent newly using lipid lowering, hypertension (HTN), or diabetes (DM) medications	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	LDL reduction under 100	Percent who achieve LDL less than 100 mg/dL or non-HDL less than 130 mg/dL	6 months
Secondary	Change in blood pressure	Change in systolic blood pressure (mm Hg)	6 months
Secondary	Change in cholesterol	Change in total cholesterol (mg/dL)	6 months
Secondary	Change in HDL	Change in HDL cholesterol (mg/dL)	6 months
Secondary	Change in non-HDL	Change in non-HDL cholesterol (mg/dL)	6 months
Secondary	Change in HbA1c	Change in hemoglobin A1c level measured in percent.	6 months
Secondary	Change in Weight	Change in weight calculated by BMI (kg/m2)	6 months
Secondary	Smoking status change	Percent of patients who quit smoking measured by self-reported response to survey question.	6 months
Secondary	Percent undergoing additional CV testing	Percent undergoing additional cardiovascular (CV) risk testing such as stress test, coronary calcium score or related imaging.	6 months
Secondary	Change in Body Surface Area (BSA) psoriasis severity	Change in percent of body surface area affected by psoriasis will be assessed.	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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