- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03737045
Psoriatic Arthritis and Psoriasis Treatment Decision Aid (DA)
February 12, 2026 updated by: University of Pennsylvania
Developing a Patient-centered Patient Decision Aid for Psoriasis and/or Psoriatic Arthritis Using Design Thinking.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Prior to the interventional study, we will develop a decision aid using design thinking.
In this interventional study, we will implement and test a patient-centered decision aid for therapy selection among patients with psoriasis and/or psoriatic arthritis who are starting or switching to a new medication.
Study Type
Interventional
Enrollment (Actual)
37
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Hospital at the University of Pennsylvania
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Decision Aid Testing
Participants will have the opportunity to test the different decision aid prototypes while selecting new treatment/therapy.
|
Participants will test decision aid prototypes that are designed to assist them in choosing a medication.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient and provider self-reported perceptions of the decision aid as measured by satisfaction survey
Time Frame: Up to 24 months
|
Satisfaction survey to rate the decision aid and shared decision-making process
|
Up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of times decision aid was used in consultation for patients switching therapies or starting a new treatment.
Time Frame: Up to 24 months
|
Rates of of the decision aid use
|
Up to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Alexis Ogdie-Beatty, MD, University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2018
Primary Completion (Actual)
December 31, 2025
Study Completion (Actual)
December 31, 2025
Study Registration Dates
First Submitted
October 31, 2018
First Submitted That Met QC Criteria
November 8, 2018
First Posted (Actual)
November 9, 2018
Study Record Updates
Last Update Posted (Actual)
February 17, 2026
Last Update Submitted That Met QC Criteria
February 12, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 831515
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Participant data will be used to create the decision aids which will then be made available to patients, researchers, and medical centers.
Physicians and researchers may request de-identified data from the PI and research plans will be reviewed on a case by case basis.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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