Educational Needs of Patients With Systemic Vasculitis

Sponsor

University of South Florida (Other)

Overall Status

Completed

CT.gov ID

NCT02190929

Collaborator

Boston University (Other), University of Pennsylvania (Other), Data Management and Coordinating Center (DMCC) (Other)

386

Enrollment

Location

23.1

Duration (Months)

16.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
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

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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

386 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Educational Needs of Patients With Systemic Vasculitis- an International Survey

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Feb 1, 2014

Actual Study Completion Date :

Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Vasculitis Contact Registry Patients Patients will be 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.

Arm

Intervention/Treatment

Vasculitis Contact Registry Patients

Patients will be 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.

Outcome Measures

Primary Outcome Measures

Preferred method and component of education materials for patients with vasculitis [Up to 24 months from the last patient assessment received]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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
University of Pennsylvania
Data Management and Coordinating Center (DMCC)

Investigators

Study Chair: Richard A Watts, DM, University of East Anglia
Study Chair: Janice Mooney, M.Sc., University of East Anglia
Study Chair: Peter C. Grayson, MD, Boston University
Study Chair: Peter A. Merkel, MD, MPH, University of Pennsylvania
Study Chair: Amanda M. Terry, MA, University of South Florida College of Medicine