Clinical trial NCT02190929: Educational Needs of Patients With Systemic Vasculitis
Official title: Educational Needs of Patients With Systemic Vasculitis- an International Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Behcet's Disease
Churg-Strauss Syndrome
Vasculitis, Central Nervous System
Giant Cell Arteritis
Wegener Granulomatosis
Henoch-Schoenlein Purpura
Microscopic Polyangiitis
Polyarteritis Nodosa
Takayasu's Arteritis
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Boston University
name: University of Pennsylvania
name: Data Management and Coordinating Center (DMCC)
First posted: 2014-07-15
Enrollment: 386
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 were recruited from within the Vasculitis Clinical Research Consortium (VCRC) Patient Contact Registry to participate in an online questionnaire. More than 3000 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: Behçets disease, Churg-Strauss Syndrome, CNS Vasculitis, Giant Cell Arteritis, granulomatosis with polyangiitis (Wegener's granulomatosis), Henoch-Schöenlein Purpura, Microscopic Polyangiitis, Polyarteritis Nodosa, or Takayasu's Arteritis.

Brief summary: A cross-sectional study design and online questionnaire was used to assess the informational needs of patients with several different types of systemic vasculitis. Patients were recruited from within the Vasculitis Clinical Research Consortium (VCRC) online Patient Contact Registry1. Survey responses from participants in the VCRC Patient Contact Registry were compared to responses from a similar survey recently administered to patients within a United Kingdom (UK) based vasculitis support group (Vasculitis UK).

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: Behçets disease, Churg-Strauss Syndrome, CNS Vasculitis, Giant Cell Arteritis, granulomatosis with polyangiitis (Wegener's granulomatosis), Henoch-Schöenlein Purpura, Microscopic Polyangiitis, Polyarteritis Nodosa, or Takayasu's Arteritis. 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, they were directed to the online questionnaire.

When completing the questionnaire, the patients were asked a series of questions. The questionnaire content was included as an appendix. The online questionnaire version was thoroughly tested for usability.

It was expected that most participants wouldrequire approximately 10-15 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 were not collected.

Eligibility criteria: Inclusion Criteria:

* Enrolled in the VCRC Contact Registry
* Patient reported diagnosis of Behçets disease, Churg-Strauss Syndrome, CNS Vasculitis, Giant Cell Arteritis, granulomatosis with polyangiitis (Wegener's granulomatosis), Henoch-Schöenlein Purpura, Microscopic Polyangiitis, Polyarteritis Nodosa, Takayasu's Arteritis.
* 18 years of age or older
* English speaking

Exclusion Criteria:

* Inability to provide informed consent and complete survey

Primary outcomes:
measure: Preferred method and component of education materials for patients with vasculitis
timeFrame: Up to 24 months from the last patient assessment received
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida Data Management Coordinating Center
state: Florida
Study officials:
affiliation: University of East Anglia
name: Richard A Watts, DM
role: STUDY_CHAIR
affiliation: University of East Anglia
name: Janice Mooney, M.Sc.
role: STUDY_CHAIR
affiliation: Boston University
name: Peter C. Grayson, MD
role: STUDY_CHAIR
affiliation: University of Pennsylvania
name: Peter A. Merkel, MD, MPH
role: STUDY_CHAIR
affiliation: University of South Florida College of Medicine
name: Amanda M. Terry, MA
role: STUDY_CHAIR
References: