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

N/AActive Not RecruitingNCT05908240

University of Pennsylvania520 enrolled

Overview

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.

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

520

Conditions

Psoriasis Psoriatic Arthritis Psoriatic Conditions Cardiovascular Diseases

Interventions

Care Coordinator ModelOTHER

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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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)

Locations (20)

Mayo Clinic

Scottsdale, Arizona, United States

Johnson Dermatology

Outcomes

Primary Outcomes

Change in LDL

Change in LDL cholesterol

Time frame: 6 months

Secondary Outcomes

Addition of new medication

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

Time frame: 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.

Time frame: 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

Time frame: 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%

Time frame: 6 months

LDL reduction under 100

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

Time frame: 6 months

Change in blood pressure

Change in systolic blood pressure (mm Hg)

Time frame: 6 months

Change in cholesterol

Change in total cholesterol (mg/dL)

Data from ClinicalTrials.gov

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Fort Smith, Arkansas, United States

University of California, Los Angeles

Los Angeles, California, United States

Southern California Dermatology

Santa Ana, California, United States

Central Connecticut Dermatology Research

Cromwell, Connecticut, United States

Northwestern University

Chicago, Illinois, United States

Dawes Fretzin Clinical Research

Columbus, Indiana, United States

Dawes Fretzin Clinical Research

Indianapolis, Indiana, United States

AP Derm Clinical Research LLC

Somerville, Massachusetts, United States

MiSkinCenter

Northville, Michigan, United States

...and 10 more locations

Time frame: 6 months

Change in HDL

Change in HDL cholesterol (mg/dL)

Time frame: 6 months

Change in non-HDL

Change in non-HDL cholesterol (mg/dL)

Time frame: 6 months

Change in HbA1c

Change in hemoglobin A1c level measured in percent.

Time frame: 6 months

Change in Weight

Change in weight calculated by BMI (kg/m2)

Time frame: 6 months

Smoking status change

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

Time frame: 6 months

Percent undergoing additional CV testing

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

Time frame: 6 months

Change in Body Surface Area (BSA) psoriasis severity

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 6 months