Prevention of Cardiovascular Disease and Mortality in Patients With Psoriasis or Psoriatic Arthritis
- Conditions
- PsoriasisPsoriatic ArthritisPsoriatic ConditionsCardiovascular Diseases
- Interventions
- Other: Care Coordinator Model
- Registration Number
- NCT05908240
- Lead Sponsor
- University of Pennsylvania
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 520
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Care Coordination Care Coordinator Model -
- Primary Outcome Measures
Name Time Method Change in LDL 6 months Change in LDL cholesterol
- Secondary Outcome Measures
Name Time Method Smoking status change 6 months Percent of patients who quit smoking measured by self-reported response to survey question.
Change in 10-year cardiovascular (CV) risk 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.
Addition of new medication 6 months Percent newly using lipid lowering, hypertension (HTN), or diabetes (DM) medications
50% LDL reduction 6 months Percent with greater than or equal to 20% risk who achieve LDL reduction of greater than or equal to 50%
Change in blood pressure 6 months Change in systolic blood pressure (mm Hg)
Change in cholesterol 6 months Change in total cholesterol (mg/dL)
Change in non-HDL 6 months Change in non-HDL cholesterol (mg/dL)
Change in Physicians Global Assessment (PGA) psoriasis severity 6 months Change in PGA score measured from 0-5 with 5 being the most severe psoriasis and 0 being the least severe.
30% LDL reduction 6 months Percent with 7.5% to 20% risk who achieve a 30% or greater reduction in LDL on follow up testing
LDL reduction under 100 6 months Percent who achieve LDL less than 100 mg/dL or non-HDL less than 130 mg/dL
Change in HDL 6 months Change in HDL cholesterol (mg/dL)
Change in HbA1c 6 months Change in hemoglobin A1c level measured in percent.
Change in Weight 6 months Change in weight calculated by BMI (kg/m2)
Percent undergoing additional CV testing 6 months Percent undergoing additional cardiovascular (CV) risk testing such as stress test, coronary calcium score or related imaging.
Change in Body Surface Area (BSA) psoriasis severity 6 months Change in percent of body surface area affected by psoriasis will be assessed.
Change in physical activity days active 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
Change in dermatology life quality index (DLQI) 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.
Change in physical activity level 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.
Patient experience with Care Coordinator Model 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.
Change in general health 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-5Dâ„¢ 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.
Change in reported psoriasis medication use 6 months Proportion of patients who have reported any change in medications taken for psoriatic disease measured through a patient reported survey.
Trial Locations
- Locations (9)
SUNY Downstate
đŸ‡ºđŸ‡¸Brooklyn, New York, United States
MiSkinCenter
đŸ‡ºđŸ‡¸Northville, Michigan, United States
City Dermatology
đŸ‡ºđŸ‡¸Bensalem, Pennsylvania, United States
University of Pennsylvania
đŸ‡ºđŸ‡¸Philadelphia, Pennsylvania, United States
Bellevue Dermatology Clinic
đŸ‡ºđŸ‡¸Bellevue, Washington, United States
University of Virginia
đŸ‡ºđŸ‡¸Charlottesville, Virginia, United States
Johnson Dermatology
đŸ‡ºđŸ‡¸Fort Smith, Arkansas, United States
Dawes Fretzin Clinical Research
đŸ‡ºđŸ‡¸Indianapolis, Indiana, United States
University of Utah
đŸ‡ºđŸ‡¸Salt Lake City, Utah, United States