Clinical trial NCT02190916: Vasculitis Illness Perception (VIP) Study
Official title: Illness Perception, Fatigue, and Function in Systemic Vasculitis (The VCRC Vasculitis Perception (VIP) Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wegener Granulomatosis
Microscopic Polyangiitis
Churg-Strauss Syndrome
Polyarteritis Nodosa
Giant Cell Arteritis
Takayasu's Arteritis
Henoch-Schoenlein Purpura
Behcet's Disease
CNS Vasculitis
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Boston University
name: Yale University
First posted: 2014-07-15
Enrollment: 707
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from within the Vasculitis Clinical Research Consortium (VCRC) Patient Contact Registry to participate in an online questionnaire. More than 2000 patients, representing all the different types of idiopathic vasculitis, are currently enrolled into the on-line registry. The different types of vasculitis available for study include: 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.

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.

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

Primary outcomes:
measure: 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.
timeFrame: 1 year after the study is closed to enrollment
Secondary outcomes:
measure: Composite measure of potential associations between illness perceptions, fatigue and function in patients with systemic vasculitis
timeFrame: 1 year after the study is closed to enrollment
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida Data Management Coordinating Center
state: Florida
Study officials:
affiliation: Boston University
name: Peter C. Grayson, MD
role: STUDY_CHAIR
affiliation: Yale University
name: Lianna Fraenkel, MD, MPH
role: STUDY_CHAIR
affiliation: Boston University
name: Peter A. Merkel, MD, MPH
role: STUDY_CHAIR
affiliation: Boston University
name: Naomia A. Amudala, NP
role: STUDY_CHAIR
affiliation: University of South Florida College of Medicine
name: Amanda M. Terry, MA
role: STUDY_CHAIR
References: