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Vasculitis Illness Perception (VIP) Study

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: NCT02190916
Recruitment Status : Completed
First Posted : July 15, 2014
Last Update Posted : July 15, 2014
Sponsor:
Collaborators:
Boston University
Yale University
Information provided by (Responsible Party):
University of South Florida

Brief Summary:
The purpose of this study is to learn about how patients with vasculitis think about their illness and to assess to what extent patient perceptions of illness are associated with physical, mental, and social functioning

Condition or disease
Wegener Granulomatosis Microscopic Polyangiitis Churg-Strauss Syndrome Polyarteritis Nodosa Giant Cell Arteritis Takayasu's Arteritis Henoch-Schoenlein Purpura Behcet's Disease CNS Vasculitis

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: granulomatosis with polyangiitis (Wegener's), microscopic polyangiitis, Churg-Strauss syndrome, polyarteritis nodosa, Takayasu's arteritis, giant cell arteritis, Behcet's disease, Henoch-Schöenlein purpura, or CNS vasculitis. 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, then they were directed to the online questionnaire.

When completing the questionnaire, patients were asked a series of questions. Some of the follow-up questions depended on initial answers. The questionnaire content was included as an appendix. The online questionnaire version was thoroughly tested for usability.

It was expected that most participants would require approximately 20-30 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 are not be collected.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 707 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Year
Official Title: Illness Perception, Fatigue, and Function in Systemic Vasculitis (The VCRC Vasculitis Perception (VIP) Study)
Study Start Date : October 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013





Primary Outcome Measures :
  1. Composite measure to include Illness perceptions, fatigue and function in patients with systemic vasculitis with further emphasis on causal beliefs about disease onset and relapse triggers. [ Time Frame: 1 year after the study is closed to enrollment ]
    The outcome measure(s) 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 both the primary and secondary outcome measures.


Secondary Outcome Measures :
  1. Composite measure of potential associations between illness perceptions, fatigue and function in patients with systemic vasculitis [ Time Frame: 1 year after the study is closed to enrollment ]
    The outcome measure(s) 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 both the primary and secondary outcome measures.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 will be recruited from within the Vasculitis Clinical Research Consortium (VCRC) Patient Contact Registry to participate in an online questionnaire. More than 2000 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: granulomatosis with polyangiitis (Wegener's granulomatosis), microscopic polyangiitis, Churg-Strauss Syndrome, polyarteritis nodosa, giant cell arteritis, Takayasu's arteritis, Henoch-Schöenlein purpura, Behçets disease, and CNS vasculitis.
Criteria

Inclusion Criteria:

  • Enrolled in VCRC Contact Registry
  • Patient reported diagnosis of granulomatosis with polyangiitis (Wegener's granulomatosis), Microscopic Polyangiitis, Churg-Strauss Syndrome, Polyarteritis Nodosa, Giant Cell Arteritis, Takayasu's Arteritis, Henoch-Schöenlein Purpura, Behçets disease, and CNS Vasculitis
  • 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): NCT02190916


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
Yale University
Investigators
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Study Chair: Peter C. Grayson, MD Boston University
Study Chair: Lianna Fraenkel, MD, MPH Yale University
Study Chair: Peter A. Merkel, MD, MPH Boston University
Study Chair: Naomia A. Amudala, NP Boston University
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: NCT02190916    
Other Study ID Numbers: 5533
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
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
Systemic Vasculitis
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Panuveitis
Uveitis
Uveal Diseases
Eye Diseases