<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/NCT01729624</url>
  </required_header>
  <id_info>
    <org_study_id>Rec No: 12/SW/0252</org_study_id>
    <nct_id>NCT01729624</nct_id>
  </id_info>
  <brief_title>PRO Development for ANCA Associated Vasculitis</brief_title>
  <official_title>A Qualitative Study Using Interviews With Patients Who Have Anti-neutrophil Cytoplasm Antibody (ANCA) Associated Vasculitis, to Develop a Patient Reported Outcome (PRO) Measure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oxford</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A qualitative study using interviews with patients who have antineutrophil cytoplasm antibody&#xD;
      (ANCA) associated vasculitis, to develop a patient reported outcome (PRO)measure&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with antineutrophil cytoplasmic antibody (ANCA) associated vasculitis (AAV) have&#xD;
      inflammation in the small blood vessels leading to involvement in different body areas, e.g.,&#xD;
      the kidneys, lungs and skin. Untreated, the risk of death is over 80%; with current&#xD;
      treatment, patients often suffer from ongoing disease activity, damage or treatment side&#xD;
      effects which have a negative impact on quality of life. Because patients with AAV can have a&#xD;
      wide range of disease features, the investigators hypothesise that general patient reported&#xD;
      outcome (PROs) measurements, may not be specific enough to describe the full impact on&#xD;
      quality of life.&#xD;
&#xD;
      The main objective of this project is to start from patients' experiences to develop a&#xD;
      disease specific PRO for patients with AAV. Patients diagnosed with AAV will be recruited&#xD;
      through clinics or inpatients at the Oxford University Hospitals (OUH) National Health&#xD;
      Service (NHS) Trust, or, if the patients have previously consented to be contacted about&#xD;
      future studies, through the Diagnostic and Classification of Vasculitis (DCVAS) or The&#xD;
      Characterisation and Determinants of Quality of Life in ANCA Associated Vasculitis (VasQoL)&#xD;
      study databases. After informed consent is obtained, individual patient interviews will be&#xD;
      conducted; these will last for approximately one hour and will be recorded and transcribed.&#xD;
      Themes will be independently extracted and amalgamated by the researchers. Approximately 25&#xD;
      patients with different types of ANCAassociated vasculitis and varying disease duration will&#xD;
      be interviewed until saturation, i.e., no new substantive themes emerge. These themes will&#xD;
      then evolve into individual candidate questionnaire items. Candidate items will be piloted on&#xD;
      approximately 25 different patients with AAV using questionnaires and interviews, until no&#xD;
      further comments arise, to produce a final set of candidate questionnaire items. The duration&#xD;
      of the study 1.5 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">August 2015</completion_date>
  <primary_completion_date type="Anticipated">August 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>This is a qualitative research study based on semi-quantitive exploratory patient interviews and therefore it is not appropriate to define only one outcome measure.</measure>
    <time_frame>No formal outcome measure therefore not applicable</time_frame>
    <description>The principle research objective: The investigators are going to interview patients with anti-neutrophil cytoplasm antibody associated vasculitis, to develop and pilot questionnaire items for a patient reported outcome measure specifically for their disease.&#xD;
The secondary research objective is to describe the impact of ANCA-associated vasculitis on the quality of life of patients attending the Oxford University Hospitals NHS Trust, based on individual anonymised interviews.</description>
  </primary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Wegener Granulomatosis</condition>
  <condition>Microscopic Polyangiitis</condition>
  <condition>Churg-Strauss Syndrome</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with ANCA-associated vasculitis seen at the Oxford University Hospitals NHS Trust.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant is willing and able to give informed consent for participation in the&#xD;
             study.&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Aged 18 years or above (no upper limit).&#xD;
&#xD;
          -  Diagnosed with granulomatosis with polyangiitis- Wegeners (GPA), Churg Strauss&#xD;
             Syndrome (CSS) or microscopic polyangiitis (MPA)and fulfil either Chapel Hill&#xD;
             consensus conference definitions or American College of Rheumatology (ACR)&#xD;
             classification criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable or unwilling to give independent written informed consent&#xD;
&#xD;
          -  Significant communication barrier e.g., inability to speak English&#xD;
&#xD;
          -  Membership of the steering committee&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Oxford</name>
      <address>
        <city>Oxford</city>
        <state>Oxfordshire</state>
        <zip>OX37LD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>May 27, 2015</last_update_submitted>
  <last_update_submitted_qc>May 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Wegener Granulomatosis</keyword>
  <keyword>Microscopic Polyangiitis</keyword>
  <keyword>Churg-Strauss Syndrome</keyword>
  <keyword>Antibodies, Antineutrophil Cytoplasmic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Granulomatosis with Polyangiitis</mesh_term>
    <mesh_term>Microscopic Polyangiitis</mesh_term>
    <mesh_term>Vasculitis</mesh_term>
    <mesh_term>Systemic Vasculitis</mesh_term>
    <mesh_term>Churg-Strauss Syndrome</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/NCT01729624
org study id: Rec No: 12/SW/0252
nct id: NCT01729624
lead sponsor: 
has dmc: Yes
A qualitative study using interviews with patients who have antineutrophil cytoplasm antibody
      (ANCA) associated vasculitis, to develop a patient reported outcome (PRO)measure
Patients with antineutrophil cytoplasmic antibody (ANCA) associated vasculitis (AAV) have
      inflammation in the small blood vessels leading to involvement in different body areas, e.g.,
      the kidneys, lungs and skin. Untreated, the risk of death is over 80%; with current
      treatment, patients often suffer from ongoing disease activity, damage or treatment side
      effects which have a negative impact on quality of life. Because patients with AAV can have a
      wide range of disease features, the investigators hypothesise that general patient reported
      outcome (PROs) measurements, may not be specific enough to describe the full impact on
      quality of life.

      The main objective of this project is to start from patients' experiences to develop a
      disease specific PRO for patients with AAV. Patients diagnosed with AAV will be recruited
      through clinics or inpatients at the Oxford University Hospitals (OUH) National Health
      Service (NHS) Trust, or, if the patients have previously consented to be contacted about
      future studies, through the Diagnostic and Classification of Vasculitis (DCVAS) or The
      Characterisation and Determinants of Quality of Life in ANCA Associated Vasculitis (VasQoL)
      study databases. After informed consent is obtained, individual patient interviews will be
      conducted; these will last for approximately one hour and will be recorded and transcribed.
      Themes will be independently extracted and amalgamated by the researchers. Approximately 25
      patients with different types of ANCAassociated vasculitis and varying disease duration will
      be interviewed until saturation, i.e., no new substantive themes emerge. These themes will
      then evolve into individual candidate questionnaire items. Candidate items will be piloted on
      approximately 25 different patients with AAV using questionnaires and interviews, until no
      further comments arise, to produce a final set of candidate questionnaire items. The duration
      of the study 1.5 years.
time perspective: Prospective
measure: This is a qualitative research study based on semi-quantitive exploratory patient interviews and therefore it is not appropriate to define only one outcome measure.
time frame: No formal outcome measure therefore not applicable
description: The principle research objective: The investigators are going to interview patients with anti-neutrophil cytoplasm antibody associated vasculitis, to develop and pilot questionnaire items for a patient reported outcome measure specifically for their disease.
The secondary research objective is to describe the impact of ANCA-associated vasculitis on the quality of life of patients attending the Oxford University Hospitals NHS Trust, based on individual anonymised interviews.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Granulomatosis with Polyangiitis
mesh term: Microscopic Polyangiitis
mesh term: Vasculitis
mesh term: Systemic Vasculitis
mesh term: Churg-Strauss Syndrome