Decision Aid for Psoriatic Arthritis and Psoriasis

(DA Trial)

Overseen By Marilyn Wan, MBChB, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Under 18, No psoriasis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

No, you don't have to stop taking your current medications. The trial does not require a washout period (time without taking certain medications), so you can continue with your existing treatments.

Is the treatment generally safe for humans?

The treatment, evaluated under different names, has been shown to be safe and well-tolerated in studies for psoriasis, with patients and physicians both concerned about avoiding severe adverse events. ^{1 2 3 4 5}

How does this treatment for psoriatic arthritis and psoriasis differ from other treatments?

This treatment involves a decision aid, which is a tool designed to help patients make informed choices about their treatment options by providing clear information and facilitating shared decision-making with healthcare providers. Unlike traditional treatments that focus solely on medication, this approach emphasizes patient involvement and understanding, which can lead to more personalized and satisfactory treatment outcomes. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Decision Aid for Psoriatic Arthritis and Psoriasis?

Research shows that using a decision aid can help people with psoriasis feel more prepared and confident when choosing treatments, which can lead to better satisfaction and outcomes. Additionally, shared decision-making, where patients and doctors work together to decide on treatments, is shown to improve patient outcomes in psoriatic arthritis. ^{7 8 9 11 12}

Who Is on the Research Team?

Alexis Ogdie-Beatty, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for adults over 18 with psoriasis or psoriatic arthritis confirmed by a specialist, starting or switching to new FDA-approved treatments. It's only for patients treated at Penn clinics who can consent to participate.

Inclusion Criteria

Treated at Penn

You do not need to stop taking any medication before participating in the study.

I am starting a new treatment for psoriasis or psoriatic arthritis.

Exclusion Criteria

I am not starting or changing any medications.

I do not have psoriasis or psoriatic arthritis.

I am unable to understand and agree to the study's details on my own.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Development

Development of a patient-centered decision aid using design thinking

Not specified

Testing

Participants test different decision aid prototypes while selecting new treatment/therapy

Up to 24 months

Follow-up

Participants are monitored for satisfaction and decision aid usage

Up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Decision Aid

Trial Overview The study aims to develop and evaluate a decision aid tool designed to help patients with psoriasis or psoriatic arthritis make informed choices about their treatment options in collaboration with their healthcare providers.

How Is the Trial Designed?

Group I: Decision Aid Testing Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Improved decisional conflict and preparedness for decision making using a patient decision aid for treatment selection in psoriasis: a pilot study. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

A patient decision aid for psoriasis based on current clinical practice guidelines. [2015]

3. England pubmed.ncbi.nlm.nih.gov

An international multi-centre analysis of current prescribing practices and shared decision-making in psoriatic arthritis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Patient preferences for psoriasis treatments: impact of treatment experience. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Patients' Perspectives on Shared Decision-Making About Medications in Psoriatic Arthritis: An Interview Study. [2023]

6. Sweden pubmed.ncbi.nlm.nih.gov

Patients' and Physicians' Preferences for Systemic Psoriasis Treatments: A Nationwide Comparative Discrete Choice Experiment (PsoCompare). [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Patient Preferences for Treatment of Psoriasis with Biologicals: A Discrete Choice Experiment. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Characteristics of Patients with Psoriasis Treated with Apremilast in the Corrona Psoriasis Registry. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Differential Drug Survival of Biologic Therapies for the Treatment of Psoriasis: A Prospective Observational Cohort Study from the British Association of Dermatologists Biologic Interventions Register (BADBIR). [2022]

10. England pubmed.ncbi.nlm.nih.gov

Trial proves apremilast is effective long-term treatment for psoriasis. [2017]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Acceptability and Feasibility of Delivering Decision Aids to Veterans for Management of Knee Osteoarthritis - A Pilot Study. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Development of Patient Decision Aids for Plaque Psoriasis and Acne. [2019]