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Completed

NCT Number: NCT02190916

Vasculitis Illness Perception (VIP) Study

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

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Key information

Conditions

Wegener Granulomatosis Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Aortic Arch Syndromes Aortic Diseases Arteritis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behcet Syndrome Behcet's Disease Blood Coagulation Disorders Brain Diseases CNS Vasculitis Cardiovascular Diseases Central Nervous System Diseases Cerebral Small Vessel Diseases Cerebrovascular Disorders Churg-Strauss Syndrome Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Genetic Diseases, Inborn Giant Cell Arteritis Granuloma Granulomatosis with Polyangiitis Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hemostatic Disorders Henoch-schoenlein Purpura Hereditary Autoinflammatory Diseases Hypersensitivity IgA Vasculitis Immune Complex Diseases Immune System Diseases Lung Diseases Lung Diseases, Interstitial Lymphatic Diseases Lymphoproliferative Disorders Microscopic Polyangiitis Mouth Diseases Nervous System Diseases Panuveitis Pathologic Processes Pathological Conditions, Signs and Symptoms Polyarteritis Nodosa Purpura Respiratory Tract Diseases Signs and Symptoms Skin Diseases Skin Diseases, Genetic Skin Diseases, Vascular Skin Manifestations Skin and Connective Tissue Diseases Stomatognathic Diseases Systemic Vasculitis Takayasu Arteritis Takayasu's Arteritis Uveal Diseases Uveitis Uveitis, Anterior Vascular Diseases Vasculitis Vasculitis, Central Nervous System

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of South Florida Data Management Coordinating Center

Tampa, Florida, 33612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

  • Boston University
  • Yale University

Registry information

Official study title

Illness Perception, Fatigue, and Function in Systemic Vasculitis (The VCRC Vasculitis Perception (VIP) Study)

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 15, 2014
Registry last updated
Jul 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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