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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
Sponsor:
Collaborators:
Boston University
University of Pennsylvania
Data Management and Coordinating Center (DMCC)
Information provided by (Responsible Party):
University of South Florida

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
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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 386 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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


Group/Cohort
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.



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

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


Locations
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United States, Florida
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
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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

Additional Information:

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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT02190929    
Other Study ID Numbers: 5534
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: July 15, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Polymyalgia Rheumatica
Behcet Syndrome
Granulomatosis with Polyangiitis
Giant Cell Arteritis
Microscopic Polyangiitis
Vasculitis, Central Nervous System
Vasculitis
Arteritis
Systemic Vasculitis
Takayasu Arteritis
Aortic Arch Syndromes
Purpura, Schoenlein-Henoch
Churg-Strauss Syndrome
Polyarteritis Nodosa
Purpura
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Skin Diseases, Vascular
Skin Diseases