Psoriatic Arthritis and Psoriasis Treatment Decision Aid
NCT03737045
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
215-220-9557
Adult Trials: 18+ Years
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.
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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| Descriptive Information | |||||||||
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| 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
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| Condition ICMJE |
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| 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 | 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:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| 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 |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | University of Pennsylvania | ||||||||
| Study Sponsor ICMJE | University of Pennsylvania | ||||||||
| Collaborators ICMJE | Pfizer | ||||||||
| Investigators ICMJE |
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| 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 | |||||||||