Clinical trial NCT05908240: Prevention of Cardiovascular Disease and Mortality in Patients With Psoriasis or Psoriatic Arthritis
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
Overall status: RECRUITING
Phase: NA
Conditions: Psoriasis
Psoriatic Arthritis
Psoriatic Conditions
Cardiovascular Diseases
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Psoriasis Foundation
First posted: 2023-06-18
Enrollment: 520
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in LDL
timeFrame: 6 months
Secondary outcomes:
measure: Addition of new medication
timeFrame: 6 months
measure: Change in 10-year cardiovascular (CV) risk
timeFrame: 6 months
measure: 30% LDL reduction
timeFrame: 6 months
measure: 50% LDL reduction
timeFrame: 6 months
measure: LDL reduction under 100
timeFrame: 6 months
measure: Change in blood pressure
timeFrame: 6 months
measure: Change in cholesterol
timeFrame: 6 months
measure: Change in HDL
timeFrame: 6 months
measure: Change in non-HDL
timeFrame: 6 months
measure: Change in HbA1c
timeFrame: 6 months
measure: Change in Weight
timeFrame: 6 months
measure: Smoking status change
timeFrame: 6 months
measure: Percent undergoing additional CV testing
timeFrame: 6 months
measure: Change in Body Surface Area (BSA) psoriasis severity
timeFrame: 6 months
measure: Change in Physicians Global Assessment (PGA) psoriasis severity
timeFrame: 6 months
measure: Change in dermatology life quality index (DLQI)
timeFrame: 6 months
measure: Change in general health
timeFrame: 6 months
measure: Change in reported psoriasis medication use
timeFrame: 6 months
measure: Change in physical activity days active
timeFrame: 6 months
measure: Change in physical activity level
timeFrame: 6 months
measure: Patient experience with Care Coordinator Model
timeFrame: 6 months
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Johnson Dermatology
state: Arkansas
city: Columbus
country: United States
facility: Dawes Fretzin Clinical Research
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research
state: Indiana
city: Northville
country: United States
facility: MiSkinCenter
state: Michigan
city: Brooklyn
country: United States
facility: SUNY Downstate
state: New York
city: Bensalem
country: United States
facility: City Dermatology
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Bellevue
country: United States
facility: Bellevue Dermatology Clinic
state: Washington
Study officials:
References: