1.) Purpose or objective of the work to be performed: At the completion of this 4-year continuation study, the study team will have completed a pilot study to determine the feasibility and acceptability, and a subsequent multi-center clinical trial to determine the effectiveness, of a novel care coordinator model for lowering cardiovascular risk in patients with psoriasis and psoriatic arthritis which is the leading cause of premature death in patients with psoriatic disease. 2.) All work associated with this research study is to be performed according to the specifications set forth in the research plan. All study procedures will be conducted in full accordance with all applicable federal and state laws and regulations including 45 CFR 46, 21 CFR Parts 50, 54, 56, and Good Clinical Practice: Consolidated Guidelines approved by the International Conference on Harmonisation (ICH). 3.) Timetable and work to be performed: It is expected that the project will be completed within 48 months. Dr. Rinad Beidas and her team at Northwestern University, will review and provide input on the design of the pilot study and develop plan for qualitative analysis (Yr.2), implement qualitative data collection and conduct data analysis (Yr.3), provide input on design of clinical trial (Yr.3), review study data, reports, and manuscripts (Yr.4-5), and participate in the dissemination of study results (Yr.5). Towards these effort, she will participate in relevant executive committee meetings.
|Effective start/end date||9/1/22 → 10/31/23|
- University of Pennsylvania (583777//NPF)
- National Psoriasis Foundation (583777//NPF)
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