Psoriatic Arthritis and Psoriasis Treatment Decision Aid

Not Applicable

Active, not recruiting

• Conditions: Psoriatic Arthritis; Psoriasis
• Interventions: Other: Decision Aid

• Registration Number: NCT03737045
• Lead Sponsor: University of Pennsylvania

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.

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 Timeline

• Study First Submitted: 2018-10-31
• Study First Submitted QC: 2018-11-08
• Study First Posted: 2018-11-09
• Study Start: 2018-12-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-24
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Decision Aid Testing	Decision Aid	Participants will have the opportunity to test the different decision aid prototypes while selecting new treatment/therapy.

Primary Outcome Measures

Name	Time	Method
Patient and provider self-reported perceptions of the decision aid as measured by satisfaction survey	Up to 24 months	Satisfaction survey to rate the decision aid and shared decision-making process

Secondary Outcome Measures

Name	Time	Method
Number of times decision aid was used in consultation for patients switching therapies or starting a new treatment.	Up to 24 months	Rates of of the decision aid use

Trial Locations

Locations (1)

Hospital at the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States