Vasculitis Illness Perception (VIP) Study

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Brief Title

Vasculitis Illness Perception (VIP) Study

Official Title

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

Brief 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
    

Detailed 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.
    


Study Type

Observational [Patient Registry]


Primary Outcome

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.

Secondary Outcome

 Composite measure of potential associations between illness perceptions, fatigue and function in patients with systemic vasculitis

Condition

Wegener Granulomatosis



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

707

Start Date

October 2011

Completion Date

October 2013

Primary Completion Date

October 2013

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Peter C. Grayson, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02190916

Organization ID

5533


Responsible Party

Sponsor

Study Sponsor

University of South Florida

Collaborators

 Boston University

Study Sponsor

Peter C. Grayson, MD, Study Chair, Boston University


Verification Date

June 2014