Psoriatic Arthritis D2P Screening

NCT04110522 | Active Not Recruiting

• 1 other identifier: IRB_00117215
• Study Type: interventional
• Target: 18,000
• Locations: 1 country
• Sites: 2

Brief Summary

The overarching goal of this study is to develop a direct-to-patient screening approach that will improve early Psoriatic Arthritis (PsA) detection in patients with psoriasis. Previously developed screening questionnaires were intended for use in the setting of a doctor's office to assist providers with referral decisions. However, these screening questionnaires are infrequently used in routine practice because of limitations with time and resources. The study will aim to develop a practical screening strategy that does not require involvement from dermatologists (or other non-rheumatology providers) and can systematically reach a broad range of psoriasis patients, including patients not attending dermatology clinics. The researchers hypothesize that disseminating questionnaires directly to patients outside of a clinic setting (direct-to-patient approach) will educate patients about their PsA risk and improve early PsA diagnoses.

Conditions

Psoriatic Arthritis

Keywords

Psoriasis

Outcome Measures

Primary Outcomes (2)

• Percentage of patients with a new PsA diagnosis

  The percentage of psoriasis patients with a new diagnosis of PsA will be compared between the Experimental Arms and the Control Arm, and compared between the two Experimental Arms (intervention with direct access to rheumatologist and intervention with standard of care referral)

  6 months

• Symptom duration

  Average duration of baseline symptoms prior to PsA diagnosis in the Experimental Arms (intervention with direct access to rheumatologist and intervention with standard of care referral) will be compared to the average duration of baseline symptoms prior to PsA diagnosis in the Control Arm

  6 months

Secondary Outcomes (9)

• Percentage of patients who complete a rheumatologic evaluation

  6 months

• Time to initial PsA diagnosis after questionnaire dissemination

  6 months

• Time to rheumatologic evaluation after questionnaire dissemination

  6 months

• Severity of PsA Disability

  6 months

• Physical function level in PsA

  6 months

Study Arms (3)

Intervention with Direct Access to Rheumatologist

EXPERIMENTAL

Psoriasis patients with no prior diagnosis of PsA randomized to receive intervention PsA questionnaire, including instructions on how to directly schedule a rheumatologic evaluation

Other: Direct to patient PsA Screening Questionnaire

Intervention with Standard of Care Referral

EXPERIMENTAL

Psoriasis patients with no prior diagnosis of PsA randomized to receive intervention PsA questionnaire, including instructions to talk with their doctor about a referral to a rheumatologist

Other: Direct to patient PsA Screening Questionnaire

Control

NO INTERVENTION

Psoriasis patients with no prior diagnosis of PsA randomized to not receive an intervention PsA questionnaire

Interventions

Direct to patient PsA Screening Questionnaire OTHER

Patients randomized to an intervention group will be asked to complete and score the 5-item Psoriasis Epidemiology Screening Tool (PEST) questionnaire. Those patients with an elevated score (PEST ≥3 out of 5) will be advised to complete a rheumatologic evaluation for PsA.

Intervention with Direct Access to Rheumatologist; Intervention with Standard of Care Referral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have an International Classification of Diseases (ICD) code diagnosis of psoriasis but without a confirmed diagnosis of Psoriatic Arthritis prior to study initiation
• Be age 18 or older
• Be geographically located within a reasonable proximity to the Rheumatology study site

You may not qualify if:

• Have psoriasis and a confirmed diagnosis of psoriatic arthritis made or confirmed by a rheumatologist

Sponsors & Collaborators

• Jessica Walsh: lead

Study Sites (2)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Arthritis, Psoriatic; Psoriasis

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jessica Walsh, M.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Rheumatology

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: October 1, 2019
• Study Start: July 22, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)