Psoriatic Arthritis and Psoriasis Treatment Decision Aid

Psoriasis Clinical Trial

— DA  

Official title:

Developing a Patient-centered Patient Decision Aid for Psoriasis and/or Psoriatic Arthritis Using Design Thinking.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03737045
• Other study ID #: 831515
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 years or older

2. Diagnosis of psoriasis (as confirmed by dermatologist) or psoriatic arthritis (as confirmed by rheumatologist)

3. Treated at Penn

In addition to the above, for the observation and implementation phases of the study:

4. 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:

1. Unable to give informed consent

2. Youth, under the age of 18 years

3. Patients without psoriasis or psoriatic arthritis

4. Not being treated at a Penn clinic

In addition to the above, for the observation and implementation phases of the study:

5. Not starting or switching to a new medication

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriasis
• Psoriatic Arthritis

Intervention

Other:
• Decision Aid
Participants will test decision aid prototypes that are designed to assist them in choosing a medication.

Locations

Country	Name	City	State
United States	Hospital at the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of times decision aid was used in consultation for patients switching therapies or starting a new treatment.	Rates of of the decision aid use	Up to 24 months