<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02190916</url>
  </required_header>
  <id_info>
    <org_study_id>5533</org_study_id>
    <nct_id>NCT02190916</nct_id>
  </id_info>
  <brief_title>Vasculitis Illness Perception (VIP) Study</brief_title>
  <official_title>Illness Perception, Fatigue, and Function in Systemic Vasculitis (The VCRC Vasculitis Perception (VIP) Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of South Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of South Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to learn about how patients with vasculitis think about their&#xD;
      illness and to assess to what extent patient perceptions of illness are associated with&#xD;
      physical, mental, and social functioning&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients enrolled in the Vasculitis Clinical Research Consortium's Contact Registry were&#xD;
      invited via email to participate in this study. The Contract Registry includes people who&#xD;
      self-identify as having one of the following types of vasculitis: granulomatosis with&#xD;
      polyangiitis (Wegener's), microscopic polyangiitis, Churg-Strauss syndrome, polyarteritis&#xD;
      nodosa, Takayasu's arteritis, giant cell arteritis, Behcet's disease, Henoch-Schöenlein&#xD;
      purpura, or CNS vasculitis. People voluntarily enroll in this Registry with the understanding&#xD;
      that they will receive information about clinical studies for which they might be eligible.&#xD;
      The introductory email included basic information about the study and all of the required&#xD;
      elements for informed consent in a brief format. Once participants agreed to participate in&#xD;
      the study, then they were directed to the online questionnaire.&#xD;
&#xD;
      When completing the questionnaire, patients were asked a series of questions. Some of the&#xD;
      follow-up questions depended on initial answers. The questionnaire content was included as an&#xD;
      appendix. The online questionnaire version was thoroughly tested for usability.&#xD;
&#xD;
      It was expected that most participants would require approximately 20-30 minutes to complete&#xD;
      the questionnaire.&#xD;
&#xD;
      The survey data is stored by the Rare Diseases Clinical Research Network Data Management and&#xD;
      Coordinating Center (DMCC) at the University of South Florida. The data is de-identified.&#xD;
      Names or other personal health information are not be collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>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.</measure>
    <time_frame>1 year after the study is closed to enrollment</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Composite measure of potential associations between illness perceptions, fatigue and function in patients with systemic vasculitis</measure>
    <time_frame>1 year after the study is closed to enrollment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <enrollment type="Actual">707</enrollment>
  <condition>Wegener Granulomatosis</condition>
  <condition>Microscopic Polyangiitis</condition>
  <condition>Churg-Strauss Syndrome</condition>
  <condition>Polyarteritis Nodosa</condition>
  <condition>Giant Cell Arteritis</condition>
  <condition>Takayasu's Arteritis</condition>
  <condition>Henoch-Schoenlein Purpura</condition>
  <condition>Behcet's Disease</condition>
  <condition>CNS Vasculitis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients will be recruited from within the Vasculitis Clinical Research Consortium (VCRC)&#xD;
        Patient Contact Registry to participate in an online questionnaire. More than 2000&#xD;
        patients, representing all the different types of idiopathic vasculitis, are currently&#xD;
        enrolled into the on-line registry. The different types of vasculitis available for study&#xD;
        include: granulomatosis with polyangiitis (Wegener's granulomatosis), microscopic&#xD;
        polyangiitis, Churg-Strauss Syndrome, polyarteritis nodosa, giant cell arteritis,&#xD;
        Takayasu's arteritis, Henoch-Schöenlein purpura, Behçets disease, and CNS vasculitis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrolled in VCRC Contact Registry&#xD;
&#xD;
          -  Patient reported diagnosis of granulomatosis with polyangiitis (Wegener's&#xD;
             granulomatosis), Microscopic Polyangiitis, Churg-Strauss Syndrome, Polyarteritis&#xD;
             Nodosa, Giant Cell Arteritis, Takayasu's Arteritis, Henoch-Schöenlein Purpura, Behçets&#xD;
             disease, and CNS Vasculitis&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide informed consent and complete survey&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter C. Grayson, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Boston University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lianna Fraenkel, MD, MPH</last_name>
    <role>Study Chair</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter A. Merkel, MD, MPH</last_name>
    <role>Study Chair</role>
    <affiliation>Boston University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Naomia A. Amudala, NP</last_name>
    <role>Study Chair</role>
    <affiliation>Boston University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Amanda M. Terry, MA</last_name>
    <role>Study Chair</role>
    <affiliation>University of South Florida College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of South Florida Data Management Coordinating Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>May 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>July 11, 2014</last_update_submitted>
  <last_update_submitted_qc>July 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polymyalgia Rheumatica</mesh_term>
    <mesh_term>Behcet Syndrome</mesh_term>
    <mesh_term>Granulomatosis with Polyangiitis</mesh_term>
    <mesh_term>Giant Cell Arteritis</mesh_term>
    <mesh_term>Microscopic Polyangiitis</mesh_term>
    <mesh_term>Vasculitis, Central Nervous System</mesh_term>
    <mesh_term>Vasculitis</mesh_term>
    <mesh_term>Arteritis</mesh_term>
    <mesh_term>Takayasu Arteritis</mesh_term>
    <mesh_term>Aortic Arch Syndromes</mesh_term>
    <mesh_term>IgA Vasculitis</mesh_term>
    <mesh_term>Churg-Strauss Syndrome</mesh_term>
    <mesh_term>Polyarteritis Nodosa</mesh_term>
    <mesh_term>Purpura</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02190916
org study id: 5533
nct id: NCT02190916
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
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
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.
observational model: Cohort
time perspective: Cross-Sectional
measure: 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
description: 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.
measure: 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
description: 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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter C. Grayson, MD
role: Study Chair
affiliation: Boston University
last name: Lianna Fraenkel, MD, MPH
role: Study Chair
affiliation: Yale University
last name: Peter A. Merkel, MD, MPH
role: Study Chair
affiliation: Boston University
last name: Naomia A. Amudala, NP
role: Study Chair
affiliation: Boston University
last name: Amanda M. Terry, MA
role: Study Chair
affiliation: University of South Florida College of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Polymyalgia Rheumatica
mesh term: Behcet Syndrome
mesh term: Granulomatosis with Polyangiitis
mesh term: Giant Cell Arteritis
mesh term: Microscopic Polyangiitis
mesh term: Vasculitis, Central Nervous System
mesh term: Vasculitis
mesh term: Arteritis
mesh term: Takayasu Arteritis
mesh term: Aortic Arch Syndromes
mesh term: IgA Vasculitis
mesh term: Churg-Strauss Syndrome
mesh term: Polyarteritis Nodosa
mesh term: Purpura