<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/NCT04487873</url>
  </required_header>
  <id_info>
    <org_study_id>GO 20/602</org_study_id>
    <nct_id>NCT04487873</nct_id>
  </id_info>
  <brief_title>COVID-19 Phobia in Patients With Bronchiectasis During Covid-19 Pandemic</brief_title>
  <official_title>COVID-19 Phobia and Quality of Life in Patients With Bronchiectasis During Covid-19 Pandemic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the literature, there are no studies evaluating COVID-19 phobia, quality of life, health&#xD;
      anxiety, physical activity level and quality of sleep in patients with bronchiectasis during&#xD;
      COVID-19 pandemic. The investigators will evaluate these parameters in patients with&#xD;
      bronchiectasis and compare the findings of healthy individuals during COVID-19 pandemic&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 23, 2020</start_date>
  <completion_date type="Actual">January 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 18, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>COVID-19 Phobia</measure>
    <time_frame>5 minutes</time_frame>
    <description>COVID-19 phobia was evaluated with COVID-19 Phobia Scale (C19P-S) and total score ranges from 20-100. Lower scores mean better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Qol</measure>
    <time_frame>10 minutes</time_frame>
    <description>Quality of life was evaluated with Nottingham Health Profile</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health anxiety</measure>
    <time_frame>10 minutes</time_frame>
    <description>Health anxiety was evaluated with Health Anxiety Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>5 minutes</time_frame>
    <description>Physical activity level was evaluated with International Physical Activity Questionnaire - Short Form (IPAQ-SF)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of sleep</measure>
    <time_frame>10 minutes</time_frame>
    <description>Quality of sleep was evaluated with Pittsburgh Sleep Quality Index</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">74</enrollment>
  <condition>Covid19</condition>
  <condition>Bronchiectasis</condition>
  <arm_group>
    <arm_group_label>Bronchiectasis</arm_group_label>
    <description>Having been diagnosed with non-cystic fibrosis bronchiectasis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy individuals</arm_group_label>
    <description>Healthy individuals without chronic disease</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients and healthy individuals between 18-60 years old, who are diagnosed with non-cystic&#xD;
        fibrosis bronchiectasis, and whose local language is Turkish will be included in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Having been diagnosed with non-cystic fibrosis bronchiectasis&#xD;
&#xD;
          -  No acute bronchiectasis exacerbation or infection in the past 2 weeks&#xD;
&#xD;
          -  Volunteering to participate in the research&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having a cognitive problem&#xD;
&#xD;
          -  Not being literate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Merve Firat, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Naciye Vardar-Yagli, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Deniz İnal-İnce, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Melda Saglam, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ebru Calik-Kütükcü, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Aslıhan Cakmak, MSc</last_name>
    <role>Study Chair</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hacettepe University, Faculty of Physical Therapy and Rehabilitation</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>May 12, 2021</last_update_submitted>
  <last_update_submitted_qc>May 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>Merve Firat</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>phobia</keyword>
  <keyword>quality of life</keyword>
  <keyword>health anxiety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Bronchiectasis</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/NCT04487873
org study id: GO 20/602
nct id: NCT04487873
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In the literature, there are no studies evaluating COVID-19 phobia, quality of life, health
      anxiety, physical activity level and quality of sleep in patients with bronchiectasis during
      COVID-19 pandemic. The investigators will evaluate these parameters in patients with
      bronchiectasis and compare the findings of healthy individuals during COVID-19 pandemic
observational model: Case-Control
time perspective: Prospective
measure: COVID-19 Phobia
time frame: 5 minutes
description: COVID-19 phobia was evaluated with COVID-19 Phobia Scale (C19P-S) and total score ranges from 20-100. Lower scores mean better outcome.
measure: Qol
time frame: 10 minutes
description: Quality of life was evaluated with Nottingham Health Profile
measure: Health anxiety
time frame: 10 minutes
description: Health anxiety was evaluated with Health Anxiety Inventory
measure: Physical activity
time frame: 5 minutes
description: Physical activity level was evaluated with International Physical Activity Questionnaire - Short Form (IPAQ-SF)
measure: Quality of sleep
time frame: 10 minutes
description: Quality of sleep was evaluated with Pittsburgh Sleep Quality Index
arm group label: Bronchiectasis
description: Having been diagnosed with non-cystic fibrosis bronchiectasis
arm group label: Healthy individuals
description: Healthy individuals without chronic disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Merve Firat, MSc
role: Principal Investigator
affiliation: Hacettepe University
last name: Naciye Vardar-Yagli, PhD
role: Study Director
affiliation: Hacettepe University
last name: Deniz İnal-İnce, Professor
role: Study Chair
affiliation: Hacettepe University
last name: Melda Saglam, PhD
role: Study Chair
affiliation: Hacettepe University
last name: Ebru Calik-Kütükcü, PhD
role: Study Chair
affiliation: Hacettepe University
last name: Aslıhan Cakmak, MSc
role: Study Chair
affiliation: Hacettepe University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: Merve Firat
investigator title: Principal Investigator
mesh term: COVID-19
mesh term: Bronchiectasis