Educational Needs of Patients With Systemic Vasculitis

Giant Cell Arteritis Clinical Trial

Official title:

Educational Needs of Patients With Systemic Vasculitis- an International Survey

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02190929
• Other study ID #: 5534
• Status: Completed
• Phase: N/A
• First received: May 30, 2014
• Last updated: July 11, 2014
• Start date: March 2012
• Est. completion date: February 2014

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

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 386
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arteritis
• Behcet Syndrome
• Behcet's Disease
• Churg-Strauss Syndrome
• 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 (4)

Lead Sponsor	Collaborator
University of South Florida	Boston University, Data Management and Coordinating Center (DMCC), University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preferred method and component of education materials for patients with vasculitis	The outcome measure 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 the primary outcome measure.	Up to 24 months from the last patient assessment received	No

External Links

•   Vasculitis Clinical Research Consortium