NCT05908240

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
520

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

10 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jun 2023Jul 2026

First Submitted

Initial submission to the registry

May 25, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

May 25, 2023

Last Update Submit

March 25, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in LDL

    Change in LDL cholesterol

    6 months

Secondary Outcomes (21)

  • Addition of new medication

    6 months

  • Change in 10-year cardiovascular (CV) risk

    6 months

  • 30% LDL reduction

    6 months

  • 50% LDL reduction

    6 months

  • LDL reduction under 100

    6 months

  • +16 more secondary outcomes

Study Arms (1)

Care Coordination

OTHER
Other: Care Coordinator Model

Interventions

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.

Care Coordination

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Johnson Dermatology

Fort Smith, Arkansas, 72916, United States

Location

Dawes Fretzin Clinical Research

Columbus, Indiana, 47201, United States

Location

Dawes Fretzin Clinical Research

Indianapolis, Indiana, 46250, United States

Location

MiSkinCenter

Northville, Michigan, 48167, United States

Location

SUNY Downstate

Brooklyn, New York, 11203, United States

Location

City Dermatology

Bensalem, Pennsylvania, 19020, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Bellevue Dermatology Clinic

Bellevue, Washington, 98004, United States

Location

MeSH Terms

Conditions

PsoriasisArthritis, PsoriaticCardiovascular Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2023

First Posted

June 18, 2023

Study Start

June 15, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations