Vasculitis Illness Perception (VIP) Study
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|ClinicalTrials.gov Identifier: NCT02190916|
Recruitment Status : Completed
First Posted : July 15, 2014
Last Update Posted : July 15, 2014
|Condition or disease|
|Wegener Granulomatosis Microscopic Polyangiitis Churg-Strauss Syndrome Polyarteritis Nodosa Giant Cell Arteritis Takayasu's Arteritis Henoch-Schoenlein Purpura Behcet's Disease CNS Vasculitis|
All patients enrolled in the Vasculitis Clinical Research Consortium's Contact Registry were invited via email to participate in this study. The Contract Registry includes people who self-identify as having one of the following types of vasculitis: granulomatosis with polyangiitis (Wegener's), microscopic polyangiitis, Churg-Strauss syndrome, polyarteritis nodosa, Takayasu's arteritis, giant cell arteritis, Behcet's disease, Henoch-Schöenlein purpura, or CNS vasculitis. People voluntarily enroll in this Registry with the understanding that they will receive information about clinical studies for which they might be eligible. The introductory email included basic information about the study and all of the required elements for informed consent in a brief format. Once participants agreed to participate in the study, then they were directed to the online questionnaire.
When completing the questionnaire, patients were asked a series of questions. Some of the follow-up questions depended on initial answers. The questionnaire content was included as an appendix. The online questionnaire version was thoroughly tested for usability.
It was expected that most participants would require approximately 20-30 minutes to complete the questionnaire.
The survey data is stored by the Rare Diseases Clinical Research Network Data Management and Coordinating Center (DMCC) at the University of South Florida. The data is de-identified. Names or other personal health information are not be collected.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||707 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Illness Perception, Fatigue, and Function in Systemic Vasculitis (The VCRC Vasculitis Perception (VIP) Study)|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
- Composite measure to include Illness perceptions, fatigue and function in patients with systemic vasculitis with further emphasis on causal beliefs about disease onset and relapse triggers. [ Time Frame: 1 year after the study is closed to enrollment ]The outcome measure(s) will be evaluated based on the cross-sectional online questionnaire. The questionnaire is the only study procedure for this online patient contact registry protocol and will be the sole analysis tool for both the primary and secondary outcome measures.
- Composite measure of potential associations between illness perceptions, fatigue and function in patients with systemic vasculitis [ Time Frame: 1 year after the study is closed to enrollment ]The outcome measure(s) will be evaluated based on the cross-sectional online questionnaire. The questionnaire is the only study procedure for this online patient contact registry protocol and will be the sole analysis tool for both the primary and secondary outcome measures.
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): NCT02190916
|United States, Florida|
|University of South Florida Data Management Coordinating Center|
|Tampa, Florida, United States, 33612|
|Study Chair:||Peter C. Grayson, MD||Boston University|
|Study Chair:||Lianna Fraenkel, MD, MPH||Yale University|
|Study Chair:||Peter A. Merkel, MD, MPH||Boston University|
|Study Chair:||Naomia A. Amudala, NP||Boston University|
|Study Chair:||Amanda M. Terry, MA||University of South Florida College of Medicine|