Psoriatic Arthritis and Psoriasis Treatment Decision Aid

NCT03737045

Last updated date
Study Location
Hospital at the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Contact
215-220-9557

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215-220-9557

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriatic Arthritis, Psoriasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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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Advanced Information
Descriptive Information
Brief Title  ICMJE Psoriatic Arthritis and Psoriasis Treatment Decision Aid
Official Title  ICMJE Developing a Patient-centered Patient Decision Aid for Psoriasis and/or Psoriatic Arthritis Using Design Thinking.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Psoriatic Arthritis
  • Psoriasis
Intervention  ICMJE Other: Decision Aid
Participants will test decision aid prototypes that are designed to assist them in choosing a medication.
Study Arms  ICMJE Decision Aid Testing
Participants will have the opportunity to test the different decision aid prototypes while selecting new treatment/therapy.
Intervention: Other: Decision Aid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 8, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2021
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marilyn Wan, MBChB, MPH215-220-9557[email protected]
Contact: Kathleen Bush215-662-6332[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03737045
Other Study ID Numbers  ICMJE 831515
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Alexis Ogdie-Beatty, MDUniversity of Pennsylvania
PRS Account University of Pennsylvania
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP