<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/NCT01672528</url>
  </required_header>
  <id_info>
    <org_study_id>12-CAD-5351</org_study_id>
    <secondary_id>RRK 4429</secondary_id>
    <secondary_id>6125</secondary_id>
    <nct_id>NCT01672528</nct_id>
  </id_info>
  <brief_title>Patient Reported Outcome Measures for Ablation of Cardiac Arrhythmias</brief_title>
  <official_title>A Multicentre, Prospective Observational Study to Develop, Evaluate and Validate Patient Reported Outcome Measures (PROMs) for Patients Treated With Cardiac Ablation for Symptomatic Cardiac Arrhythmias</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cardiff and Vale University Health Board</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Health and Clinical Excellence</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital Birmingham NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Newcastle-upon-Tyne Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cardiff and Vale University Health Board</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A multicentre, prospective observational study to develop, evaluate and validate Patient&#xD;
      Reported Outcome Measures (PROMs) for patients treated with cardiac ablation for symptomatic&#xD;
      cardiac arrhythmias&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to develop, evaluate and validate disease specific PROMs for patients in the&#xD;
      UK treated with cardiac ablation for cardiac arrhythmias. The potential benefits include&#xD;
      support for clinicians to improve their performance, assisting patients in making informed&#xD;
      choices and strengthening audit and research.&#xD;
&#xD;
      Phase 1 of the study will involve patient interviews with approximately 30 patients from 2&#xD;
      sites. These, together with input from a multidisciplinary team, will aim to improve drafts&#xD;
      of disease specific questionnaires. This will be followed by Phase 2 which will trial the&#xD;
      questionnaires in a group of approximately 600 patients from three sites. In Phase 2 patients&#xD;
      will be asked to complete a pre-procedure questionnaire relating to their symptoms, quality&#xD;
      of life and procedure expectations. They will also be sent post-procedure questionnaires&#xD;
      relating to procedural outcomes, symptoms and quality of life at 8-16 weeks post procedure&#xD;
      and at 1 and 5 years post-procedure.&#xD;
&#xD;
      The responses obtained from these PROMs will be used to undertake recommended statistical&#xD;
      tests of reliability and validity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Is a newly developed disease specific tool able to accurately detect changes in health status following ablation for symptomatic cardiac arrhythmias?</measure>
    <time_frame>Up to 5 years post ablation</time_frame>
    <description>This will be measured using responses to the new tool, EQ5D5L and clinical outcomes. Statistical evidence of the reliability and validity of the instruments will be illustrated via standard statistical methods.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Do replies to the questionnaires show that the tool is responsive to change following ablation treatment?</measure>
    <time_frame>Average 10 weeks post ablation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Do PROMs responses show concurrent, convergent and discriminant validity; corresponding with responses to EQ5D and clinical outcomes?</measure>
    <time_frame>Up to 5 years post-ablation.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Is the tool sensitive to detecting whether patient expectations are met following ablation procedures for cardiac arrhythmias?</measure>
    <time_frame>Average 10 weeks post ablation</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">586</enrollment>
  <condition>Cardiac Arrhythmia</condition>
  <arm_group>
    <arm_group_label>Cardiac arrhythmia patients</arm_group_label>
    <description>Patients with cardiac arrhythmias consented to and awaiting a cardiac ablation procedure or post ablation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interview</intervention_name>
    <description>Patient participates in a face-to-face interview to facilitate development of the new disease specific questionnaire</description>
    <arm_group_label>Cardiac arrhythmia patients</arm_group_label>
    <other_name>Disease specific questionnaire</other_name>
    <other_name>EQ5D5L</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Patients will be sent questionnaires before their procedure, 8 - 12 after their procedure and at 1 and 5 years post procedure</description>
    <arm_group_label>Cardiac arrhythmia patients</arm_group_label>
    <other_name>Disease specific questionnaire</other_name>
    <other_name>EQ5D</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Cardiac arrhythmia clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with symptomatic cardiac arrhythmias&#xD;
&#xD;
          -  Consented to and awaiting a cardiac ablation procedure&#xD;
&#xD;
          -  Able to read, write and understand English or Welsh&#xD;
&#xD;
          -  Capable of giving informed written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not able to read, write and understand English or Welsh&#xD;
&#xD;
          -  Not able to provide informed written consent&#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>Grace Carolan-Rees, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cardiff and Vale University Health Board</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospitals Birmingham Foundation Trust</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 2PR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiff and Vale University Health Board</name>
      <address>
        <city>Cardiff</city>
        <zip>CF14 7XB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newcastle Upon Tyne Hospitals NHS Trusts</name>
      <address>
        <city>Newcastle</city>
        <zip>NE7 7DN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <last_update_submitted>January 17, 2020</last_update_submitted>
  <last_update_submitted_qc>January 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cardiff and Vale University Health Board</investigator_affiliation>
    <investigator_full_name>Dr Grace Carolan-Rees</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>Patient Reported Outcome Measures</keyword>
  <keyword>PROMs</keyword>
  <keyword>Cardiac arrhythmia</keyword>
  <keyword>Cardiac ablation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arrhythmias, Cardiac</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/NCT01672528
org study id: 12-CAD-5351
secondary id: RRK 4429
secondary id: 6125
nct id: NCT01672528
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
A multicentre, prospective observational study to develop, evaluate and validate Patient
      Reported Outcome Measures (PROMs) for patients treated with cardiac ablation for symptomatic
      cardiac arrhythmias
This study aims to develop, evaluate and validate disease specific PROMs for patients in the
      UK treated with cardiac ablation for cardiac arrhythmias. The potential benefits include
      support for clinicians to improve their performance, assisting patients in making informed
      choices and strengthening audit and research.

      Phase 1 of the study will involve patient interviews with approximately 30 patients from 2
      sites. These, together with input from a multidisciplinary team, will aim to improve drafts
      of disease specific questionnaires. This will be followed by Phase 2 which will trial the
      questionnaires in a group of approximately 600 patients from three sites. In Phase 2 patients
      will be asked to complete a pre-procedure questionnaire relating to their symptoms, quality
      of life and procedure expectations. They will also be sent post-procedure questionnaires
      relating to procedural outcomes, symptoms and quality of life at 8-16 weeks post procedure
      and at 1 and 5 years post-procedure.

      The responses obtained from these PROMs will be used to undertake recommended statistical
      tests of reliability and validity.
observational model: Cohort
time perspective: Prospective
measure: Is a newly developed disease specific tool able to accurately detect changes in health status following ablation for symptomatic cardiac arrhythmias?
time frame: Up to 5 years post ablation
description: This will be measured using responses to the new tool, EQ5D5L and clinical outcomes. Statistical evidence of the reliability and validity of the instruments will be illustrated via standard statistical methods.
measure: Do replies to the questionnaires show that the tool is responsive to change following ablation treatment?
time frame: Average 10 weeks post ablation
measure: Do PROMs responses show concurrent, convergent and discriminant validity; corresponding with responses to EQ5D and clinical outcomes?
time frame: Up to 5 years post-ablation.
measure: Is the tool sensitive to detecting whether patient expectations are met following ablation procedures for cardiac arrhythmias?
time frame: Average 10 weeks post ablation
arm group label: Cardiac arrhythmia patients
description: Patients with cardiac arrhythmias consented to and awaiting a cardiac ablation procedure or post ablation.
intervention type: Other
intervention name: Interview
description: Patient participates in a face-to-face interview to facilitate development of the new disease specific questionnaire
arm group label: Cardiac arrhythmia patients
other name: Disease specific questionnaire
other name: EQ5D5L
intervention type: Other
intervention name: Questionnaires
description: Patients will be sent questionnaires before their procedure, 8 - 12 after their procedure and at 1 and 5 years post procedure
arm group label: Cardiac arrhythmia patients
other name: Disease specific questionnaire
other name: EQ5D
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Grace Carolan-Rees, PhD
role: Principal Investigator
affiliation: Cardiff and Vale University Health Board
facility: 
facility: 
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Cardiff and Vale University Health Board
investigator full name: Dr Grace Carolan-Rees
investigator title: Director
mesh term: Arrhythmias, Cardiac