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

Primary Purpose

Psoriasis, Psoriatic Arthritis, Psoriatic Conditions

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Care Coordinator Model
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Psoriasis

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Care Coordination

Arm Description

Outcomes

Primary Outcome Measures

Change in LDL
Change in LDL cholesterol

Secondary Outcome Measures

Addition of new medication
Percent newly using lipid lowering, hypertension (HTN), or diabetes (DM) medications
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.
30% LDL reduction
Percent with 7.5% to 20% risk who achieve a 30% or greater reduction in LDL on follow up testing
50% LDL reduction
Percent with greater than or equal to 20% risk who achieve LDL reduction of greater than or equal to 50%
LDL reduction under 100
Percent who achieve LDL less than 100 mg/dL or non-HDL less than 130 mg/dL
Change in blood pressure
Change in systolic blood pressure (mm Hg)
Change in cholesterol
Change in total cholesterol (mg/dL)
Change in HDL
Change in HDL cholesterol (mg/dL)
Change in non-HDL
Change in non-HDL cholesterol (mg/dL)
Change in HbA1c
Change in hemoglobin A1c level measured in percent.
Change in Weight
Change in weight calculated by BMI (kg/m2)
Smoking status change
Percent of patients who quit smoking measured by self-reported response to survey question.
Percent undergoing additional CV testing
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
Change in percent of body surface area affected by psoriasis will be assessed.
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.
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.
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.
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.
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
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.
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.

Full Information

First Posted
May 25, 2023
Last Updated
July 10, 2023
Sponsor
University of Pennsylvania
Collaborators
National Psoriasis Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05908240
Brief Title
Prevention of Cardiovascular Disease and Mortality in Patients With Psoriasis or Psoriatic Arthritis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Psoriasis Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Psoriatic Arthritis, Psoriatic Conditions, Cardiovascular Diseases

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
520 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Care Coordination
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Care Coordinator Model
Intervention Description
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 Outcome Measure Information:
Title
Change in LDL
Description
Change in LDL cholesterol
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Addition of new medication
Description
Percent newly using lipid lowering, hypertension (HTN), or diabetes (DM) medications
Time Frame
6 months
Title
Change in 10-year cardiovascular (CV) risk
Description
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
Title
30% LDL reduction
Description
Percent with 7.5% to 20% risk who achieve a 30% or greater reduction in LDL on follow up testing
Time Frame
6 months
Title
50% LDL reduction
Description
Percent with greater than or equal to 20% risk who achieve LDL reduction of greater than or equal to 50%
Time Frame
6 months
Title
LDL reduction under 100
Description
Percent who achieve LDL less than 100 mg/dL or non-HDL less than 130 mg/dL
Time Frame
6 months
Title
Change in blood pressure
Description
Change in systolic blood pressure (mm Hg)
Time Frame
6 months
Title
Change in cholesterol
Description
Change in total cholesterol (mg/dL)
Time Frame
6 months
Title
Change in HDL
Description
Change in HDL cholesterol (mg/dL)
Time Frame
6 months
Title
Change in non-HDL
Description
Change in non-HDL cholesterol (mg/dL)
Time Frame
6 months
Title
Change in HbA1c
Description
Change in hemoglobin A1c level measured in percent.
Time Frame
6 months
Title
Change in Weight
Description
Change in weight calculated by BMI (kg/m2)
Time Frame
6 months
Title
Smoking status change
Description
Percent of patients who quit smoking measured by self-reported response to survey question.
Time Frame
6 months
Title
Percent undergoing additional CV testing
Description
Percent undergoing additional cardiovascular (CV) risk testing such as stress test, coronary calcium score or related imaging.
Time Frame
6 months
Title
Change in Body Surface Area (BSA) psoriasis severity
Description
Change in percent of body surface area affected by psoriasis will be assessed.
Time Frame
6 months
Title
Change in Physicians Global Assessment (PGA) psoriasis severity
Description
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
Title
Change in dermatology life quality index (DLQI)
Description
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
Title
Change in general health
Description
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
Title
Change in reported psoriasis medication use
Description
Proportion of patients who have reported any change in medications taken for psoriatic disease measured through a patient reported survey.
Time Frame
6 months
Title
Change in physical activity days active
Description
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
Title
Change in physical activity level
Description
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
Title
Patient experience with Care Coordinator Model
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brooke Bishop, MPH
Phone
267-581-9714
Email
Brooke.Bishop@pennmedicine.upenn.edu
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brooke Bishop, MPH
Phone
267-581-9714
Email
Brooke.Bishop@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Joel M Gelfand, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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