PsoriasisCP3NCT05908240
Prevention of Cardiovascular Disease and Mortality in Patients With Psoriasis or Psoriatic Arthritis
A study testing Care Coordinator Model in people with Psoriasis and Psoriatic Arthritis, run by University of Pennsylvania at 20 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Psoriasis, Psoriatic Arthritis, Psoriatic Conditions
- What is being tested?
- Care Coordinator Model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 603 participants
- Where
- 20 sitesUnited States
- Study dates
- 15 Jun 2023to 16 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
University of New Mexico
Albuquerque, New Mexico, 87106
Bellevue Dermatology Clinic
Bellevue, Washington, 98004
City Dermatology
Bensalem, Pennsylvania, 19020
SUNY Downstate
Brooklyn, New York, 11203
University of Virginia
Charlottesville, Virginia, 22903
Northwestern University
Chicago, Illinois, 60611
Dawes Fretzin Clinical Research
Columbus, Indiana, 47201
Central Connecticut Dermatology Research
Cromwell, Connecticut, 06416
Johnson Dermatology
Fort Smith, Arkansas, 72916
Dawes Fretzin Clinical Research
Indianapolis, Indiana, 46250
University of California, Los Angeles
Los Angeles, California, 90095
Frontier Dermatology
Mill Creek, Washington, 98012
MiSkinCenter
Northville, Michigan, 48167
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Utah
Salt Lake City, Utah, 84112
Southern California Dermatology
Santa Ana, California, 92701
Mayo Clinic
Scottsdale, Arizona, 85259
AP Derm Clinical Research LLC
Somerville, Massachusetts, 02145
Buffalo Medical Group
Williamsville, New York, 14221
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
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
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.
Read the 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.
- Being tested
- Care Coordinator Model
- Medical subject headings
- Psoriasis, Arthritis, Psoriatic, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Care Coordination | Other | Not described Receives: Other: Care Coordinator Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LDL
Change in LDL cholesterol
Measured: 6 months
Secondary outcomes (21)
Addition of new medication
Percent newly using lipid lowering, hypertension (HTN), or diabetes (DM) medications
Measured: 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.
Measured: 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
Measured: 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%
Measured: 6 months
LDL reduction under 100
Percent who achieve LDL less than 100 mg/dL or non-HDL less than 130 mg/dL
Measured: 6 months
Change in blood pressure
Change in systolic blood pressure (mm Hg)
Measured: 6 months
Change in cholesterol
Change in total cholesterol (mg/dL)
Measured: 6 months
Change in HDL
Change in HDL cholesterol (mg/dL)
Measured: 6 months
Change in non-HDL
Change in non-HDL cholesterol (mg/dL)
Measured: 6 months
Change in HbA1c
Change in hemoglobin A1c level measured in percent.
Measured: 6 months
Change in Weight
Change in weight calculated by BMI (kg/m2)
Measured: 6 months
Smoking status change
Percent of patients who quit smoking measured by self-reported response to survey question.
Measured: 6 months
Percent undergoing additional CV testing
Percent undergoing additional cardiovascular (CV) risk testing such as stress test, coronary calcium score or related imaging.
Measured: 6 months
Change in Body Surface Area (BSA) psoriasis severity
Change in percent of body surface area affected by psoriasis will be assessed.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start15 Jun 2023
- Primary completion12 Sep 2026
- Study completion16 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 603 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Psoriasis Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908240
- Sponsor's protocol ID
- 853218
- Acronym
- CP3
- Status last verified
- Oct 2026
- First submitted
- 25 May 2023
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05908240
- Acronym / sponsor ID
- CP3 / 853218
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 603 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Psoriasis Foundation
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 12 Sep 2026 (actual)
- Study completion
- 16 Oct 2026 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Care Coordination | Other | Other: Care Coordinator Model |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care Coordinator ModelA 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. | Other | Care Coordination |
Primary outcome
Change in LDL
Time frame: 6 months
Change in LDL cholesterol
21 secondary outcomes
Addition of new medication
Time frame: 6 months
Change in 10-year cardiovascular (CV) risk
Time frame: 6 months
30% LDL reduction
Time frame: 6 months
50% LDL reduction
Time frame: 6 months
LDL reduction under 100
Time frame: 6 months
Change in blood pressure
Time frame: 6 months
Change in cholesterol
Time frame: 6 months
Change in HDL
Time frame: 6 months
Change in non-HDL
Time frame: 6 months
Change in HbA1c
Time frame: 6 months
Change in Weight
Time frame: 6 months
Smoking status change
Time frame: 6 months
Percent undergoing additional CV testing
Time frame: 6 months
Change in Body Surface Area (BSA) psoriasis severity
Time frame: 6 months
Change in Physicians Global Assessment (PGA) psoriasis severity
Time frame: 6 months
Change in dermatology life quality index (DLQI)
Time frame: 6 months
Change in general health
Time frame: 6 months
Change in reported psoriasis medication use
Time frame: 6 months
Change in physical activity days active
Time frame: 6 months
Change in physical activity level
Time frame: 6 months
Patient experience with Care Coordinator Model
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Psoriasis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Coordinator Model in people with Psoriasis and Psoriatic Arthritis, run by University of Pennsylvania at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in LDL (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.