xml: <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/NCT05963503</url>
    </required_header>
    <id_info>
      <org_study_id>GO 22/114</org_study_id>
      <nct_id>NCT05963503</nct_id>
    </id_info>
    <brief_title>Relationship Between Health Literacy and Physical Activity in Adult Patients With Cystic Fibrosis</brief_title>
    <official_title>Investigation of Relationship Between Health Literacy and Physical Activity, Anxiety and Depression, Adherence to Airway Clearance Techniques in Adult Patients With Cystic Fibrosis</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>
        The purpose of this study investigation of relationship between health literacy and physical&#xD;
        activity, anxiety and depression, adherence to airway clearance techniques in adult patients&#xD;
        with cystic fibrosis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The assessment will begin with demographic information then health literacy, depression and&#xD;
        anxiety and physical activity level will evaluation with related questionnaires.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</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>Health Literacy</measure>
      <time_frame>5 minutes</time_frame>
      <description>Health literacy will be evaluated with Health Literacy Scale. This scale total score ranges from 25-125 and lower scores show that lower health literacy.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Anxiety and Depression</measure>
      <time_frame>5 minutes</time_frame>
      <description>Anxiety and depression will be evaluated with Hospital Anxiety and Depression Scale. A score of 11 or more indicates mood disorders. Anxiety or depression subscales score ranges from 0-21.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical Activity</measure>
      <time_frame>3 minutes</time_frame>
      <description>Physical activity will be evaluated with International Physical Activity Questionnaire Short Form.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adherence to Airway Clearance Tecniques</measure>
      <time_frame>1 minute</time_frame>
      <description>Frequency of used airway clearance tecniques for a week</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Cystic Fibrosis</condition>
    <arm_group>
      <arm_group_label>Cystic Fibrosis</arm_group_label>
      <description>Inclusion Criteria:&#xD;
  have a confirmed diagnosis of CF stable clinical condition 18-65 ages volunteering to participate&#xD;
  Exclusion Criteria:&#xD;
  having a serious comorbidity that limits mobilization or participation in physical activity being illiterate having cognitive problems being pregnant incomplete answers to surveys</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Controls</arm_group_label>
      <description>Inclusion Criteria:&#xD;
  18-65 ages volunteering to participate&#xD;
  Exclusion Criteria:&#xD;
  having any cardiopulmonary disease having cognitive problems being illiterate</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Assessments</intervention_name>
      <description>Health literacy Anxiety and depression Physical activity Adherence to airway clearance techniques</description>
      <arm_group_label>Controls</arm_group_label>
      <arm_group_label>Cystic Fibrosis</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Cystic fibrosis and healthy participants between 18-65 years old.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          be between the ages of 18-65 volunteering to participate&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          having any cardiopulmonary disease having cognitive problems being illiterate&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Naciye Vardar Yağlı</last_name>
      <role>Study Director</role>
      <affiliation>Hacettepe University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ebru Damadoğlu</last_name>
      <role>Study Chair</role>
      <affiliation>Hacettepe University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Oğuz Karcıoğlu</last_name>
      <role>Study Chair</role>
      <affiliation>Hacettepe University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Aydan Aslı Aksel Uylar</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hacettepe University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Aydan Aslı Aksel Uylar</last_name>
      <phone>+90312</phone>
      <phone_ext>3051576</phone_ext>
      <email>aydanaaksel@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hacettepe University</name>
        <address>
          <city>Ankara</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hacettepe University</investigator_affiliation>
      <investigator_full_name>Aydan Aslı Aksel Uylar</investigator_full_name>
      <investigator_title>Physiotherapist</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cystic Fibrosis</mesh_term>
      <mesh_term>Fibrosis</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05963503
  org study id: GO 22/114
  nct id: NCT05963503
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study investigation of relationship between health literacy and physical
        activity, anxiety and depression, adherence to airway clearance techniques in adult patients
        with cystic fibrosis.
  The assessment will begin with demographic information then health literacy, depression and
        anxiety and physical activity level will evaluation with related questionnaires.
  observational model: Case-Control
  time perspective: Prospective
  measure: Health Literacy
  time frame: 5 minutes
  description: Health literacy will be evaluated with Health Literacy Scale. This scale total score ranges from 25-125 and lower scores show that lower health literacy.
  measure: Anxiety and Depression
  time frame: 5 minutes
  description: Anxiety and depression will be evaluated with Hospital Anxiety and Depression Scale. A score of 11 or more indicates mood disorders. Anxiety or depression subscales score ranges from 0-21.
  measure: Physical Activity
  time frame: 3 minutes
  description: Physical activity will be evaluated with International Physical Activity Questionnaire Short Form.
  measure: Adherence to Airway Clearance Tecniques
  time frame: 1 minute
  description: Frequency of used airway clearance tecniques for a week
  arm group label: Cystic Fibrosis
  description: Inclusion Criteria:
  have a confirmed diagnosis of CF stable clinical condition 18-65 ages volunteering to participate
  Exclusion Criteria:
  having a serious comorbidity that limits mobilization or participation in physical activity being illiterate having cognitive problems being pregnant incomplete answers to surveys
  arm group label: Controls
  description: Inclusion Criteria:
  18-65 ages volunteering to participate
  Exclusion Criteria:
  having any cardiopulmonary disease having cognitive problems being illiterate
  intervention type: Other
  intervention name: Assessments
  description: Health literacy Anxiety and depression Physical activity Adherence to airway clearance techniques
  arm group label: Controls
  arm group label: Cystic Fibrosis
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Naciye Vardar Yağlı
  role: Study Director
  affiliation: Hacettepe University
  last name: Ebru Damadoğlu
  role: Study Chair
  affiliation: Hacettepe University
  last name: Oğuz Karcıoğlu
  role: Study Chair
  affiliation: Hacettepe University
  last name: Aydan Aslı Aksel Uylar
  role: Principal Investigator
  affiliation: Hacettepe University
  last name: Aydan Aslı Aksel Uylar
  phone: +90312
  phone ext: 3051576
  email: aydanaaksel@gmail.com
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Hacettepe University
  investigator full name: Aydan Aslı Aksel Uylar
  investigator title: Physiotherapist
  mesh term: Cystic Fibrosis
  mesh term: Fibrosis