<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/NCT04463628</url>
  </required_header>
  <id_info>
    <org_study_id>MUCONFIN</org_study_id>
    <nct_id>NCT04463628</nct_id>
  </id_info>
  <brief_title>Impacts of the Covid-19 Epidemic and Associated Lockdown Measures on the Management, Health and Behaviors of Cystic Fibrosis Patients During the 2020 Epidemic</brief_title>
  <acronym>MUCONFIN</acronym>
  <official_title>Impacts of the Covid-19 Epidemic and Associated Lockdown Measures on the Management, Health and Behaviors of Cystic Fibrosis Patients During the 2020 Epidemic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Intercommunal Creteil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Intercommunal Creteil</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Impacts of the Covid-19 epidemic and associated lockdown measures on the management, health&#xD;
      and behaviors of cystic fibrosis patients during the 2020 epidemic&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The containment of the population in France is a health measure implemented in response to&#xD;
      SARS-CoV-2 (Covid-19) infection. For cystic fibrosis, as for many chronic diseases, this&#xD;
      disruption is twofold. On the one hand, it affects daily life due to the closure of schools&#xD;
      and the introduction of national lockdown, but also the hospital, which has profoundly&#xD;
      changed its procedures, which are almost completely focused on the care of patients with&#xD;
      Covid-19. This forced transformation was at the expense of its usual role including the&#xD;
      management of chronic diseases such as cystic fibrosis. It has an impact on patients'&#xD;
      consultations cancelled, rescheduled or replaced by teleconsultations, hospitalisations&#xD;
      whether scheduled or during acute exacerbations which are more complicated to organise.&#xD;
      Access to treatments is also more difficult (physiotherapy), which can affect compliance.&#xD;
      Confinement also profoundly changes the lives of our patients. It changes the way individuals&#xD;
      can apprehend their disease and its integration into their everyday life, studies or&#xD;
      professional projects. Finally, it is the confrontation with a potentially fatal infection&#xD;
      that reminds us of the risks and consequences of a potentially severe chronic disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2020</start_date>
  <completion_date type="Actual">March 1, 2022</completion_date>
  <primary_completion_date type="Actual">December 30, 2021</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>Cancellation or postponement of consultations by the health professional or patient,</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Number of consultations cancelled or postponed by the health professional or patient of consultations (medical and paramedical),</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient cancellation of teleconsultations/telecare replacement,</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Number of consultations cancelled by the teleconsultation/replacement patient,</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cancellation or postponement by the health care institution or by the patient of hospitalizations (scheduled or unscheduled),</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Number of consultations cancelled or postponed by the health care institution or by the patient of hospitalizations (acute or scheduled)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the modalities of administration of antibiotics cures (oral instead of intravenous administration).</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Number of patients affected by the change in the modality of administration of antibiotic cures (intravenous instead of intravenous administration).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The reduction of each of the elements of care provision and health care utilization:</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Cancellation or postponement by the patient of consultations (medical or paramedical)&#xD;
Patient cancellation of teleconsultations/telecare proposed by the health professional&#xD;
Cancellation or postponement by the patient of hospitalizations (acute or scheduled)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of modality of administration of antibiotic cures</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Intravenous instead of intravenous administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Questionnaire about taking or not taking treatment during confinement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and stress (at risk of being affected by COVID-19 or at risk of being treated less well)</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Scale 0-21</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence or absence of toxic consumption (drug, alcohol) during the lockdown</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>A questionnaire on the presence or absence of toxic consumption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the knowledge, experience and social representations of the risk of Covid-19</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Experience and social representations of confinement by cystic fibrosis patients (evaluated by qualitative methods)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessing the role of social inequalities in the consequences of lockdown</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Role of social inequalities in the consequences of containment assessed by qualitative methods</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Suspected and/or confirmed Covid-19 in patients with cystic fibrosis.</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Prevalence of suspected and/or confirmed Covid-19 infections in patients with cystic fibrosis</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">746</enrollment>
  <condition>Cystic Fibrosis in Children</condition>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>Questionnaire and/or interview</arm_group_label>
    <description>An online questionnaire to assess the quantitative aspect of the impact of lockdown on all areas of the cystic fibrosis patient's health, be it physical, mental or social (using quality of life assessment in particular and interviews in the human and social sciences).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>The study questionnaire was constructed as follows:&#xD;
One part is composed of validated questionnaires: Cystic fibrosis specific self-questionnaire for quality of life, questionnaire for screening for anxiety disorder.&#xD;
The other part, which was not validated, was constructed as follows: questionnaire on knowledge of Covid-19 adapted to the new exceptional situation (Covid-19 pandemic) and specific questions adapted to the research objective on Covid-19 from the questionnaire of the French Public Health survey, to monitor changes in behaviour and mental health during lockdown</description>
    <arm_group_label>Questionnaire and/or interview</arm_group_label>
    <other_name>Quantitative aspect</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Interview</intervention_name>
    <description>Two interviews in the human and social sciences, conducted by recorded video-conference, will be proposed to 15 patients during and after the lockdown.Two interviews will take place: one during the lockdown and one at 6 months from the first interview (or at the end of the confinement if it lasts more than 6 months). The interviews will be conducted independently of the results of the questionnaire.</description>
    <arm_group_label>Questionnaire and/or interview</arm_group_label>
    <other_name>Qualitative aspect</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will be proposed to cystic fibrosis patients residing in France.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with cystic fibrosis (Southern Chlorine &gt; 60 mEq/L and/or presence of 2&#xD;
             pathogenic mutations on the CFTR gene)&#xD;
&#xD;
          -  Supported in a French CRCM (Cystic fibrosis Resource and Competence Center)&#xD;
&#xD;
          -  Affiliated to a social security scheme&#xD;
&#xD;
          -  Non-opposition for participation in the protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minor patient under 14 years of age&#xD;
&#xD;
          -  Computer equipment or internet connection defect&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Intercommunal hospital of Créteil</name>
      <address>
        <city>Creteil</city>
        <state>IDF</state>
        <zip>94000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TROUSSEAU Hospital</name>
      <address>
        <city>Paris</city>
        <state>IDF</state>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FOCH Hospital</name>
      <address>
        <city>Suresnes</city>
        <state>IDF</state>
        <zip>92150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>August 17, 2022</last_update_submitted>
  <last_update_submitted_qc>August 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lockdown</keyword>
  <keyword>Covid-19 Epidemic</keyword>
  <keyword>questionnaire</keyword>
  <keyword>interview</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04463628
org study id: MUCONFIN
nct id: NCT04463628
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Impacts of the Covid-19 epidemic and associated lockdown measures on the management, health
      and behaviors of cystic fibrosis patients during the 2020 epidemic
The containment of the population in France is a health measure implemented in response to
      SARS-CoV-2 (Covid-19) infection. For cystic fibrosis, as for many chronic diseases, this
      disruption is twofold. On the one hand, it affects daily life due to the closure of schools
      and the introduction of national lockdown, but also the hospital, which has profoundly
      changed its procedures, which are almost completely focused on the care of patients with
      Covid-19. This forced transformation was at the expense of its usual role including the
      management of chronic diseases such as cystic fibrosis. It has an impact on patients'
      consultations cancelled, rescheduled or replaced by teleconsultations, hospitalisations
      whether scheduled or during acute exacerbations which are more complicated to organise.
      Access to treatments is also more difficult (physiotherapy), which can affect compliance.
      Confinement also profoundly changes the lives of our patients. It changes the way individuals
      can apprehend their disease and its integration into their everyday life, studies or
      professional projects. Finally, it is the confrontation with a potentially fatal infection
      that reminds us of the risks and consequences of a potentially severe chronic disease.
observational model: Cohort
time perspective: Prospective
measure: Cancellation or postponement of consultations by the health professional or patient,
time frame: Up to 6 months
description: Number of consultations cancelled or postponed by the health professional or patient of consultations (medical and paramedical),
measure: Patient cancellation of teleconsultations/telecare replacement,
time frame: Up to 6 months
description: Number of consultations cancelled by the teleconsultation/replacement patient,
measure: Cancellation or postponement by the health care institution or by the patient of hospitalizations (scheduled or unscheduled),
time frame: Up to 6 months
description: Number of consultations cancelled or postponed by the health care institution or by the patient of hospitalizations (acute or scheduled)
measure: Change in the modalities of administration of antibiotics cures (oral instead of intravenous administration).
time frame: Up to 6 months
description: Number of patients affected by the change in the modality of administration of antibiotic cures (intravenous instead of intravenous administration).
measure: The reduction of each of the elements of care provision and health care utilization:
time frame: Up to 6 months
description: Cancellation or postponement by the patient of consultations (medical or paramedical)
Patient cancellation of teleconsultations/telecare proposed by the health professional
Cancellation or postponement by the patient of hospitalizations (acute or scheduled)
measure: The change of modality of administration of antibiotic cures
time frame: Up to 6 months
description: Intravenous instead of intravenous administration
measure: Compliance
time frame: Up to 6 months
description: Questionnaire about taking or not taking treatment during confinement
measure: Anxiety and stress (at risk of being affected by COVID-19 or at risk of being treated less well)
time frame: Up to 6 months
description: Scale 0-21
measure: Presence or absence of toxic consumption (drug, alcohol) during the lockdown
time frame: Up to 6 months
description: A questionnaire on the presence or absence of toxic consumption
measure: Evaluation of the knowledge, experience and social representations of the risk of Covid-19
time frame: Up to 6 months
description: Experience and social representations of confinement by cystic fibrosis patients (evaluated by qualitative methods)
measure: Assessing the role of social inequalities in the consequences of lockdown
time frame: Up to 6 months
description: Role of social inequalities in the consequences of containment assessed by qualitative methods
measure: Suspected and/or confirmed Covid-19 in patients with cystic fibrosis.
time frame: Up to 6 months
description: Prevalence of suspected and/or confirmed Covid-19 infections in patients with cystic fibrosis
arm group label: Questionnaire and/or interview
description: An online questionnaire to assess the quantitative aspect of the impact of lockdown on all areas of the cystic fibrosis patient's health, be it physical, mental or social (using quality of life assessment in particular and interviews in the human and social sciences).
intervention type: Behavioral
intervention name: Questionnaire
description: The study questionnaire was constructed as follows:
One part is composed of validated questionnaires: Cystic fibrosis specific self-questionnaire for quality of life, questionnaire for screening for anxiety disorder.
The other part, which was not validated, was constructed as follows: questionnaire on knowledge of Covid-19 adapted to the new exceptional situation (Covid-19 pandemic) and specific questions adapted to the research objective on Covid-19 from the questionnaire of the French Public Health survey, to monitor changes in behaviour and mental health during lockdown
arm group label: Questionnaire and/or interview
other name: Quantitative aspect
intervention type: Behavioral
intervention name: Interview
description: Two interviews in the human and social sciences, conducted by recorded video-conference, will be proposed to 15 patients during and after the lockdown.Two interviews will take place: one during the lockdown and one at 6 months from the first interview (or at the end of the confinement if it lasts more than 6 months). The interviews will be conducted independently of the results of the questionnaire.
arm group label: Questionnaire and/or interview
other name: Qualitative aspect
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 14 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Cystic Fibrosis
mesh term: Fibrosis
sharing ipd: No