<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/NCT02189070</url>
  </required_header>
  <id_info>
    <org_study_id>K13-28</org_study_id>
    <nct_id>NCT02189070</nct_id>
  </id_info>
  <brief_title>The PAtient Preference Analysis of Yearly Follow-up After PCI (PAPAYA)</brief_title>
  <acronym>PAPAYA</acronym>
  <official_title>What Patients Really Want - Patient Preferences Regarding Annual Follow-up After Medical Interventions: The PAPAYA Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thorax Centrum Twente</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Thorax Centrum Twente</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the preference of patients regarding the approach&#xD;
      for follow-up after percutaneous coronary intervention (PCI) procedures. We hypothesize that&#xD;
      patients prefer questionnaires for annual follow-up assessment when compared to telephone or&#xD;
      email.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale: Assessment and reporting of long-term clinical follow-up after medical&#xD;
      interventions is essential for transparency of medical care and its quality improvement.&#xD;
      However follow-up adherence is a serious challenge in clinical trials. Taking the patient&#xD;
      preference of the mode of follow-up into account is likely to enhance trial adherence, reduce&#xD;
      withdrawals, and facilitate a longer follow-up duration. No data on patient preference of&#xD;
      annual follow-up have been reported.&#xD;
&#xD;
      Objective: To investigate the patient preference of approach to obtain follow-up information&#xD;
      after percutaneous coronary intervention (PCI)&#xD;
&#xD;
      Study design: Single-center, prospective, observational registry&#xD;
&#xD;
      Study population: All patients enrolled in the percutaneous coronary intervention studies&#xD;
      TWENTE trial (a broad study population reflecting real-world PCI patients) and DUTCH PEERS&#xD;
      trial (an all-comers population), who were treated at Thoraxcentrum Twente in Enschede&#xD;
      between June 2008 and May 2012&#xD;
&#xD;
      Intervention: All subjects will receive a questionnaire with questions regarding their&#xD;
      preference with regards to the approach of acquiring follow-up information after PCI.&#xD;
&#xD;
      Main study endpoints:&#xD;
&#xD;
        -  The primary endpoint is the patient preference on how to be approached for annual&#xD;
           follow-up after PCI procedures.&#xD;
&#xD;
        -  Secondary endpoints include&#xD;
&#xD;
             1. least preferred approach of follow-up&#xD;
&#xD;
             2. the preferred number of follow-up moments per year&#xD;
&#xD;
             3. the from the patients' perspective maximum acceptable number of questions to be&#xD;
                answered&#xD;
&#xD;
             4. the assessment of potential relationships between the most and least preferred&#xD;
                approach of assessment and patient age, gender urgency of PCI treatment, and&#xD;
                history of previous revascularizations&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">August 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>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Assessment of preferred approach for annual follow-up after PCI</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Least preferred approach for follow up</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum acceptable number of questions to be answered</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">2566</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Responders</arm_group_label>
    <description>Responding participants</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-responders</arm_group_label>
    <description>Non-responding participants</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All patients enrolled in the percutaneous coronary intervention (PCI) studies TWENTE trial&#xD;
        (a broad study population reflecting real-world PCI patients) and DUTCH PEERS trial (an&#xD;
        all-comers populatoin), who were treated at Thoraxcentrum Twente in Enschede between June&#xD;
        2008 and May 2012&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients enrolled in the TWENTE trial and DUTCH PEERS trial (an all-comers&#xD;
             population, who were treated at Thoraxcentrum Twente in Enschede between June 2008 and&#xD;
             May 2012&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who had withdrawn their consent for participation in the TWENTE and DUTCH&#xD;
             PEERS trials, respectively. Patients who passed away during follow-up could obviously&#xD;
             not be approached for further questioning.&#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>Clemens von Birgelen, MD,PhD,Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Thorax Centrum Twente</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medisch Spectrum Twente</name>
      <address>
        <city>Enschede</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>May 13, 2015</last_update_submitted>
  <last_update_submitted_qc>May 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 14, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Thorax Centrum Twente</investigator_affiliation>
    <investigator_full_name>Clemens von Birgelen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Follow-up</keyword>
  <keyword>Percutaneous coronary intervention</keyword>
  <keyword>Patient preference</keyword>
  <keyword>DUTCH PEERS</keyword>
  <keyword>TWENTE</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</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/NCT02189070
org study id: K13-28
nct id: NCT02189070
lead sponsor: 
has dmc: No
The purpose of this study is to determine the preference of patients regarding the approach
      for follow-up after percutaneous coronary intervention (PCI) procedures. We hypothesize that
      patients prefer questionnaires for annual follow-up assessment when compared to telephone or
      email.
Rationale: Assessment and reporting of long-term clinical follow-up after medical
      interventions is essential for transparency of medical care and its quality improvement.
      However follow-up adherence is a serious challenge in clinical trials. Taking the patient
      preference of the mode of follow-up into account is likely to enhance trial adherence, reduce
      withdrawals, and facilitate a longer follow-up duration. No data on patient preference of
      annual follow-up have been reported.

      Objective: To investigate the patient preference of approach to obtain follow-up information
      after percutaneous coronary intervention (PCI)

      Study design: Single-center, prospective, observational registry

      Study population: All patients enrolled in the percutaneous coronary intervention studies
      TWENTE trial (a broad study population reflecting real-world PCI patients) and DUTCH PEERS
      trial (an all-comers population), who were treated at Thoraxcentrum Twente in Enschede
      between June 2008 and May 2012

      Intervention: All subjects will receive a questionnaire with questions regarding their
      preference with regards to the approach of acquiring follow-up information after PCI.

      Main study endpoints:

        -  The primary endpoint is the patient preference on how to be approached for annual
           follow-up after PCI procedures.

        -  Secondary endpoints include

             1. least preferred approach of follow-up

             2. the preferred number of follow-up moments per year

             3. the from the patients' perspective maximum acceptable number of questions to be
                answered

             4. the assessment of potential relationships between the most and least preferred
                approach of assessment and patient age, gender urgency of PCI treatment, and
                history of previous revascularizations
observational model: Cohort
time perspective: Prospective
measure: Assessment of preferred approach for annual follow-up after PCI
time frame: 1 year
measure: Least preferred approach for follow up
time frame: 1 year
measure: Maximum acceptable number of questions to be answered
time frame: 1 year
arm group label: Responders
description: Responding participants
arm group label: Non-responders
description: Non-responding participants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clemens von Birgelen, MD,PhD,Prof
role: Principal Investigator
affiliation: Thorax Centrum Twente
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Thorax Centrum Twente
investigator full name: Clemens von Birgelen
investigator title: Professor
mesh term: Coronary Artery Disease