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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a tool called the Decision Aid, which helps individuals with psoriasis or psoriatic arthritis make informed treatment choices with their doctors. It guides patients in deciding on a new therapy or when switching treatments. Individuals treated at Penn who are starting or switching to a new treatment for psoriasis or psoriatic arthritis can participate. As an unphased trial, this study offers a unique opportunity to contribute to research that could improve decision-making tools for future patients.

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.

What prior data suggests that this decision aid is safe for use in patients with psoriasis and/or psoriatic arthritis?

Research has shown that decision aids, such as the one being tested in this study for psoriatic arthritis and psoriasis, are generally safe. These tools help patients understand their treatment options by simplifying complex information and explaining the benefits, risks, and steps involved in different treatments.

Unlike medical treatments, this digital tool poses no safety concerns because it supports decision-making. There are no physical side effects or risks from using a decision aid. Its purpose is to make treatment choices clearer and more informed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Decision Aid for Psoriatic Arthritis and Psoriasis because it aims to empower patients in making more informed choices about their treatment options. Unlike standard treatments like biologics, DMARDs (disease-modifying anti-rheumatic drugs), and topical therapies, which focus directly on symptom management, this decision aid concentrates on enhancing patient involvement and understanding in the treatment selection process. By testing various prototypes, the decision aid could potentially improve patient satisfaction and outcomes by ensuring that chosen therapies align more closely with individual patient preferences and lifestyle needs.

What evidence suggests that this decision aid is effective for psoriasis and psoriatic arthritis?

Research has shown that decision aids can greatly assist people with psoriasis and psoriatic arthritis in choosing treatments. These tools provide clear information about the effectiveness of different treatments on skin, nails, and joints. They also explain possible side effects and how treatments are administered. In this trial, participants will test different decision aid prototypes while selecting new treatments or therapies. One study found that decision aids help patients better understand their options and feel more confident about their treatment choices. By providing specific chances of outcomes, decision aids guide patients to make informed decisions that best fit their needs and conditions. ^{1 2 3 5 6}

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8248141/

Online decision aid for patients with psoriasis - PMC The therapeutic outcomes covered in the PDA are efficacy (on skin, nails and joints), most frequent side‐effects, frequency and route of administration, ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39825419/

Rationale and design of a randomized clinical trial ... - PubMed In a two parallel-arm randomized controlled trial, we are assessing an innovative eHealth delivery model that integrates PrEP with MOUD.

3. mi-arthritis.com mi-arthritis.com/patient-decision-aids-psoriatic-arthritis/

Patient Decision Aids: Psoriatic Arthritis Decision aids are neutral informational tools designed to guide patients toward a good decision. They show specific probabilities about outcomes to aid ...

4. informed-decisions.org informed-decisions.org/psoriasispda.php

Welcome to the Psoriasis Decision Aid Welcome to the Psoriasis Decision Aid. This decision aid has six steps to guide you through the process of choosing which treatment option best suits you.

5. cdn.bad.org.uk cdn.bad.org.uk/uploads/2021/12/19174019/Decision-aid-2023.pdf

Decision aid for biologic therapy for psoriasis This is a decision aid to help clinicians and patients decide their treatment choice and not a comprehensive data source or replacement for the individual drug ...

6. acrabstracts.org acrabstracts.org/abstract/utilizing-design-thinking-to-develop-a-decision-aid-for-patients-with-psoriasis-and-psoriatic-arthritis/

Utilizing Design Thinking to Develop a Decision Aid for ... Wan M, Almonte M, Gelfand J, Ogdie A. Utilizing Design Thinking to Develop a Decision Aid for Patients with Psoriasis and Psoriatic Arthritis [abstract].