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Psoriatic Arthritis and Psoriasis Treatment Decision Aid (DA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03737045
Recruitment Status : Recruiting
First Posted : November 9, 2018
Last Update Posted : April 6, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Psoriasis Other: Decision Aid Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Patients and providers will use a web-based or paper decision aid. They will not be assigned to specific arms or undergo randomized treatment.
Masking: None (Open Label)
Masking Description: Participants will have a choice of decision aids (web or paper) and will not be blinded. The study team will be aware of each prototype and decision aid that participants use.
Primary Purpose: Other
Official Title: Developing a Patient-centered Patient Decision Aid for Psoriasis and/or Psoriatic Arthritis Using Design Thinking.
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2021


Arm Intervention/treatment
Decision Aid Testing
Participants will have the opportunity to test the different decision aid prototypes while selecting new treatment/therapy.
Other: Decision Aid
Participants will test decision aid prototypes that are designed to assist them in choosing a medication.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03737045


Contacts
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Contact: Marilyn Wan, MBChB, MPH 215-220-9557 Marilyn.Wan@uphs.upenn.edu
Contact: Kathleen Bush 215-662-6332 katbu@upenn.edu

Locations
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United States, Pennsylvania
Hospital at the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kathleen Bush, BS    215-662-6332    katbu@upenn.edu   
Principal Investigator: Alexis Ogdie-Beatty, MD, MSCE         
Sponsors and Collaborators
University of Pennsylvania
Pfizer
Investigators
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Principal Investigator: Alexis Ogdie-Beatty, MD University of Pennsylvania
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03737045    
Other Study ID Numbers: 831515
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Pennsylvania:
Decision Aid
Shared Decision-Making
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Psoriasis
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases