Vasculitis Illness Perception (VIP) Study

Sponsor

University of South Florida (Other)

Overall Status

Completed

CT.gov ID

NCT02190916

Collaborator

Boston University (Other), Yale University (Other)

707

Enrollment

Location

Duration (Months)

29.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Wegener Granulomatosis Microscopic Polyangiitis Churg-Strauss Syndrome Polyarteritis Nodosa Giant Cell Arteritis Takayasu's Arteritis Henoch-Schoenlein Purpura Behcet's Disease CNS Vasculitis

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

707 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Oct 1, 2013

Outcome Measures

Primary Outcome Measures

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. [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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of South Florida Data Management Coordinating Center	Tampa	Florida	United States	33612

Sponsors and Collaborators

University of South Florida
Boston University
Yale University

Investigators

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