Educational Needs of Patients With Systemic Vasculitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02190929|
Recruitment Status : Completed
First Posted : July 15, 2014
Last Update Posted : July 15, 2014
|Condition or disease|
|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|
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 Type :||Observational [Patient Registry]|
|Actual Enrollment :||386 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Educational Needs of Patients With Systemic Vasculitis- an International Survey|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
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.
- Preferred method and component of education materials for patients with vasculitis [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02190929
|United States, Florida|
|University of South Florida Data Management Coordinating Center|
|Tampa, Florida, United States, 33612|
|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|