<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/NCT02223780</url>
  </required_header>
  <id_info>
    <org_study_id>Projet 13-102</org_study_id>
    <secondary_id>406740_145086/1</secondary_id>
    <nct_id>NCT02223780</nct_id>
  </id_info>
  <brief_title>Early Palliative Care for Patients With Severe and Very Severe COPD: a Randomised Study</brief_title>
  <official_title>Can Early Introduction of Specialized Palliative Care Limit Intensive Care, Emergency and Hospital Admissions in Patients With Severe and Very Severe COPD? A Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Geneva</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Swiss National Science Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Geneva</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic obstructive pulmonary disease (COPD) is a common and, despite existing treatment&#xD;
      options, progressive lung disease. Patients with COPD often have only limited access to&#xD;
      palliative care. The goal of this research project is to improve the quality of life of&#xD;
      patients with COPD.&#xD;
&#xD;
      Background In many cases, the symptoms of advanced COPD (including shortness of breath, pain&#xD;
      and depression) are insufficiently alleviated. In addition, often in connection with an&#xD;
      infection, patients frequently suffer from respiratory decompensation; this may lead to&#xD;
      invasive interventions as well as the admission to the emergency room or an intensive care&#xD;
      unit. It may ultimately lead to the death of the patient.&#xD;
&#xD;
      Aim This study aims to show that early palliative care can reduce the number of necessary&#xD;
      invasive interventions and improve the quality of life of patients with COPD. For this&#xD;
      purpose, a group of patients receiving early, standardized palliative care will be compared&#xD;
      to a group of patients receiving customary treatment only, without systematic intervention by&#xD;
      palliative care experts.&#xD;
&#xD;
      Significance The results of this study should make it possible to efficiently use the medical&#xD;
      resources which are required for the appropriate care of patients with COPD. The goal is the&#xD;
      best possible quality of life and better coordination of the measures taken, especially with&#xD;
      regard to the area of acute care and the wishes of the patient.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of the study is to assess the effectiveness of the introduction of&#xD;
      early specialized palliative care on hospital, intensive care unit and emergency admissions&#xD;
      of patients with severe and very severe COPD&#xD;
&#xD;
      Secondary objectives are:&#xD;
&#xD;
      The impact of early palliative care on the mood and anxiety of patients with severe and very&#xD;
      severe COPD The impact of early palliative care on the health-related quality of life of&#xD;
      patients with severe and very severe COPD.&#xD;
&#xD;
      The impact of early palliative care on the prescription of antibiotics during the last month&#xD;
      of life of patients 4. The impact of early palliative care on advance care planning and&#xD;
      end-of-life decision-making will be compared between the two groups Methodology Randomized&#xD;
      study to one of the two groups in a ratio without stratification.&#xD;
&#xD;
      Study Duration 3 years Study Center(s) Single-center study Number of Subjects 180 patients&#xD;
      Intervention Early specialized palliative care intervention Significance Given the trends&#xD;
      toward aggressive and costly care near end-of-life among patients with COPD, a timely&#xD;
      introduction of palliative care may limit unnecessary and burdensome personal and societal&#xD;
      costs, and invasive approaches. The results of this study may provide some direction for&#xD;
      future palliative care interventions in this particular population&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2013</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>length of stay hospital, intensive care unit and emergency admissions</measure>
    <time_frame>1 year</time_frame>
    <description>number of days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>depression and anxiety</measure>
    <time_frame>1 year</time_frame>
    <description>HADS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life assessed by a generic questionnaire</measure>
    <time_frame>1 year</time_frame>
    <description>SF-36</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>standard management</description>
  </arm_group>
  <arm_group>
    <arm_group_label>early palliative care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>early palliative care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>early palliative care</intervention_name>
    <description>the patients will benefit from an early palliative care consultation</description>
    <arm_group_label>control</arm_group_label>
    <arm_group_label>early palliative care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD defined according to GOLD criteria (FEV1/FVC &lt; 70%) stage III or IV (FEV1 &lt; 50%&#xD;
             predicted)&#xD;
&#xD;
               -  and/or long term treatment with either domiciliary oxygen or home mechanical&#xD;
                  ventilation&#xD;
&#xD;
               -  and or one or more hospital admissions in the previous year for an acute&#xD;
                  exacerbation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Moderate or severe cognitive impairment (MMSE&lt;20)&#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>Jean-Paul Janssens, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Geneva</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Geneva</name>
      <address>
        <city>Geneva</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <link>
    <url>http://www.nfp67.ch/</url>
    <description>link of the national fund</description>
  </link>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>October 31, 2021</last_update_submitted>
  <last_update_submitted_qc>October 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Geneva</investigator_affiliation>
    <investigator_full_name>Jean-Paul Janssens</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>palliative care</keyword>
  <!-- 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/NCT02223780
org study id: Projet 13-102
secondary id: 406740_145086/1
nct id: NCT02223780
lead sponsor: 
collaborator: 
has dmc: Yes
Chronic obstructive pulmonary disease (COPD) is a common and, despite existing treatment
      options, progressive lung disease. Patients with COPD often have only limited access to
      palliative care. The goal of this research project is to improve the quality of life of
      patients with COPD.

      Background In many cases, the symptoms of advanced COPD (including shortness of breath, pain
      and depression) are insufficiently alleviated. In addition, often in connection with an
      infection, patients frequently suffer from respiratory decompensation; this may lead to
      invasive interventions as well as the admission to the emergency room or an intensive care
      unit. It may ultimately lead to the death of the patient.

      Aim This study aims to show that early palliative care can reduce the number of necessary
      invasive interventions and improve the quality of life of patients with COPD. For this
      purpose, a group of patients receiving early, standardized palliative care will be compared
      to a group of patients receiving customary treatment only, without systematic intervention by
      palliative care experts.

      Significance The results of this study should make it possible to efficiently use the medical
      resources which are required for the appropriate care of patients with COPD. The goal is the
      best possible quality of life and better coordination of the measures taken, especially with
      regard to the area of acute care and the wishes of the patient.
The primary objective of the study is to assess the effectiveness of the introduction of
      early specialized palliative care on hospital, intensive care unit and emergency admissions
      of patients with severe and very severe COPD

      Secondary objectives are:

      The impact of early palliative care on the mood and anxiety of patients with severe and very
      severe COPD The impact of early palliative care on the health-related quality of life of
      patients with severe and very severe COPD.

      The impact of early palliative care on the prescription of antibiotics during the last month
      of life of patients 4. The impact of early palliative care on advance care planning and
      end-of-life decision-making will be compared between the two groups Methodology Randomized
      study to one of the two groups in a ratio without stratification.

      Study Duration 3 years Study Center(s) Single-center study Number of Subjects 180 patients
      Intervention Early specialized palliative care intervention Significance Given the trends
      toward aggressive and costly care near end-of-life among patients with COPD, a timely
      introduction of palliative care may limit unnecessary and burdensome personal and societal
      costs, and invasive approaches. The results of this study may provide some direction for
      future palliative care interventions in this particular population
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: length of stay hospital, intensive care unit and emergency admissions
time frame: 1 year
description: number of days
measure: depression and anxiety
time frame: 1 year
description: HADS
measure: Health related quality of life assessed by a generic questionnaire
time frame: 1 year
description: SF-36
arm group label: control
arm group type: Placebo Comparator
description: standard management
arm group label: early palliative care
arm group type: Active Comparator
description: early palliative care
intervention type: Other
intervention name: early palliative care
description: the patients will benefit from an early palliative care consultation
arm group label: control
arm group label: early palliative care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Paul Janssens, MD
role: Principal Investigator
affiliation: University Hospital, Geneva
facility: 
country: Switzerland
url: http://www.nfp67.ch/
description: link of the national fund
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Geneva
investigator full name: Jean-Paul Janssens
investigator title: Professor