Psoriatic Arthritis and Psoriasis Treatment Decision Aid

NCT03737045 | Completed

• 1 other identifier: 831515
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to create and test a patient decision aid that facilitates the shared decision-making process when patients with psoriasis and/or psoriatic arthritis are starting or switching to a new therapy.

Conditions

Psoriasis; Psoriatic Arthritis

Keywords

Decision Aid; Shared Decision-Making

Outcome Measures

Primary Outcomes (1)

• Patient and provider self-reported perceptions of the decision aid as measured by satisfaction survey

  Satisfaction survey to rate the decision aid and shared decision-making process

  Up to 24 months

Secondary Outcomes (1)

• Number of times decision aid was used in consultation for patients switching therapies or starting a new treatment.

  Up to 24 months

Study Arms (1)

Decision Aid Testing

OTHER

Participants will have the opportunity to test the different decision aid prototypes while selecting new treatment/therapy.

Other: Decision Aid

Interventions

Decision Aid OTHER

Participants will test decision aid prototypes that are designed to assist them in choosing a medication.

Decision Aid Testing

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older
• Diagnosis of psoriasis (as confirmed by dermatologist) or psoriatic arthritis (as confirmed by rheumatologist)
• Treated at Penn
• In addition to the above, for the observation and implementation phases of the study:
• Initiation of a new psoriasis or psoriatic arthritis treatment
• Biosimilars that have been approved by the FDA and available on the US market will similarly be eligible for participation
• Patients may be taking other traditional DMARDs.
• A washout period is not required.

You may not qualify if:

• Unable to give informed consent
• Youth, under the age of 18 years
• Patients without psoriasis or psoriatic arthritis
• Not being treated at a Penn clinic
• In addition to the above, for the observation and implementation phases of the study:
• Not starting or switching to a new medication

Sponsors & Collaborators

• University of Pennsylvania: lead
• Pfizer: collaborator

Study Sites (1)

Hospital at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Arthritis, Psoriatic; Psoriasis

Interventions

Decision Support Techniques

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

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Alexis Ogdie-Beatty, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants will have a choice of decision aids (web or paper) and will not be blinded. The study team will be aware of each prototype and decision aid that participants use.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients and providers will use a web-based or paper decision aid. They will not be assigned to specific arms or undergo randomized treatment.

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 9, 2018
• Study Start: December 1, 2018
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)