Vasculitis Illness Perception (VIP) Study

Giant Cell Arteritis Clinical Trial

Official title:

Illness Perception, Fatigue, and Function in Systemic Vasculitis (The VCRC Vasculitis Perception (VIP) Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02190916
• Other study ID #: 5533
• Status: Completed
• Phase: N/A
• First received: May 30, 2014
• Last updated: July 11, 2014
• Start date: October 2011
• Est. completion date: October 2013

Study information

• Verified date: June 2014
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to learn about how patients with vasculitis think about their illness and to assess to what extent patient perceptions of illness are associated with physical, mental, and social functioning

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 707
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Enrolled in VCRC Contact Registry

• Patient reported diagnosis of granulomatosis with polyangiitis (Wegener's granulomatosis), Microscopic Polyangiitis, Churg-Strauss Syndrome, Polyarteritis Nodosa, Giant Cell Arteritis, Takayasu's Arteritis, Henoch-Schöenlein Purpura, Behçets disease, and CNS Vasculitis

• 18 years of age or older

• English speaking

Exclusion Criteria:

• Inability to provide informed consent and complete survey

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arteritis
• Behcet Syndrome
• Behcet's Disease
• Churg-Strauss Syndrome
• CNS Vasculitis
• Giant Cell Arteritis
• Henoch-Schoenlein Purpura
• Microscopic Polyangiitis
• Polyarteritis Nodosa
• Polymyalgia Rheumatica
• Purpura, Schoenlein-Henoch
• Systemic Vasculitis
• Takayasu Arteritis
• Takayasu's Arteritis
• Vasculitis
• Vasculitis, Central Nervous System
• Wegener Granulomatosis

Locations

Country	Name	City	State
United States	University of South Florida Data Management Coordinating Center	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of South Florida	Boston University, Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	1 year after the study is closed to enrollment	No
Secondary	Composite measure of potential associations between illness perceptions, fatigue and function in patients with systemic vasculitis	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.	1 year after the study is closed to enrollment	No

External Links

•   Vasculitis Clinical Research Consortium