<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/NCT02190929</url>
  </required_header>
  <id_info>
    <org_study_id>5534</org_study_id>
    <nct_id>NCT02190929</nct_id>
  </id_info>
  <brief_title>Educational Needs of Patients With Systemic Vasculitis</brief_title>
  <official_title>Educational Needs of Patients With Systemic Vasculitis- an International Survey</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>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Data Management and Coordinating Center (DMCC)</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>
      A cross-sectional study design and online questionnaire was used to assess the informational&#xD;
      needs of patients with several different types of systemic vasculitis. Patients were&#xD;
      recruited from within the Vasculitis Clinical Research Consortium (VCRC) online Patient&#xD;
      Contact Registry1. Survey responses from participants in the VCRC Patient Contact Registry&#xD;
      were compared to responses from a similar survey recently administered to patients within a&#xD;
      United Kingdom (UK) based vasculitis support group (Vasculitis UK).&#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: Behçets disease,&#xD;
      Churg-Strauss Syndrome, CNS Vasculitis, Giant Cell Arteritis, granulomatosis with&#xD;
      polyangiitis (Wegener's granulomatosis), Henoch-Schöenlein Purpura, Microscopic Polyangiitis,&#xD;
      Polyarteritis Nodosa, or Takayasu's Arteritis. People voluntarily enroll in this Registry&#xD;
      with the understanding that they will receive information about clinical studies for which&#xD;
      they might be eligible. The introductory email included basic information about the study and&#xD;
      all of the required elements for informed consent in a brief format. Once participants agreed&#xD;
      to participate in the study, they were directed to the online questionnaire.&#xD;
&#xD;
      When completing the questionnaire, the patients were asked a series of questions. The&#xD;
      questionnaire content was included as an appendix. The online questionnaire version was&#xD;
      thoroughly tested for usability.&#xD;
&#xD;
      It was expected that most participants wouldrequire approximately 10-15 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 were not collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</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>Preferred method and component of education materials for patients with vasculitis</measure>
    <time_frame>Up to 24 months from the last patient assessment received</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">386</enrollment>
  <condition>Behcet's Disease</condition>
  <condition>Churg-Strauss Syndrome</condition>
  <condition>Vasculitis, Central Nervous System</condition>
  <condition>Giant Cell Arteritis</condition>
  <condition>Wegener Granulomatosis</condition>
  <condition>Henoch-Schoenlein Purpura</condition>
  <condition>Microscopic Polyangiitis</condition>
  <condition>Polyarteritis Nodosa</condition>
  <condition>Takayasu's Arteritis</condition>
  <arm_group>
    <arm_group_label>Vasculitis Contact Registry Patients</arm_group_label>
    <description>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.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients were recruited from within the Vasculitis Clinical Research Consortium (VCRC)&#xD;
        Patient Contact Registry to participate in an online questionnaire. More than 3000&#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: Behçets disease, Churg-Strauss Syndrome, CNS Vasculitis, Giant Cell Arteritis,&#xD;
        granulomatosis with polyangiitis (Wegener's granulomatosis), Henoch-Schöenlein Purpura,&#xD;
        Microscopic Polyangiitis, Polyarteritis Nodosa, or Takayasu's Arteritis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrolled in the VCRC Contact Registry&#xD;
&#xD;
          -  Patient reported diagnosis of Behçets disease, Churg-Strauss Syndrome, CNS Vasculitis,&#xD;
             Giant Cell Arteritis, granulomatosis with polyangiitis (Wegener's granulomatosis),&#xD;
             Henoch-Schöenlein Purpura, Microscopic Polyangiitis, Polyarteritis Nodosa, Takayasu's&#xD;
             Arteritis.&#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>Richard A Watts, DM</last_name>
    <role>Study Chair</role>
    <affiliation>University of East Anglia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Janice Mooney, M.Sc.</last_name>
    <role>Study Chair</role>
    <affiliation>University of East Anglia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter C. Grayson, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Boston University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter A. Merkel, MD, MPH</last_name>
    <role>Study Chair</role>
    <affiliation>University of Pennsylvania</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>Systemic Vasculitis</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/NCT02190929
org study id: 5534
nct id: NCT02190929
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
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).
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.
observational model: Cohort
time perspective: Cross-Sectional
measure: Preferred method and component of education materials for patients with vasculitis
time frame: Up to 24 months from the last patient assessment received
description: 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.
arm group label: Vasculitis Contact Registry Patients
description: 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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Richard A Watts, DM
role: Study Chair
affiliation: University of East Anglia
last name: Janice Mooney, M.Sc.
role: Study Chair
affiliation: University of East Anglia
last name: Peter C. Grayson, MD
role: Study Chair
affiliation: Boston University
last name: Peter A. Merkel, MD, MPH
role: Study Chair
affiliation: University of Pennsylvania
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: Systemic Vasculitis
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