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/NCT06027333</url>
    </required_header>
    <id_info>
      <org_study_id>BernerRehaZentrum</org_study_id>
      <nct_id>NCT06027333</nct_id>
    </id_info>
    <brief_title>Self-efficacy and Well-being of Patients With Fibrotic Interstitial Lung Disease</brief_title>
    <official_title>Self-efficacy and Well-being of Patients With Fibrotic Interstitial Lung Disease - an Observational Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Berner Reha Zentrum AG</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Insel Gruppe AG, University Hospital Bern</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Zurich University of Applied Sciences</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Zurich</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Berner Reha Zentrum AG</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>
        Patients with fibrotic insterstitial lung disease (ILD) participating in inpatient&#xD;
        rehabilitation or in outpatient pulmonary care will be invited to participate in this&#xD;
        observational study. Patients will fill out questionnaire regarding quality of life and&#xD;
        symptoms at baseline and follow-up (at the end of rehabilitation or after the second&#xD;
        outpatient ILD consultation). Additionally, clinical data obtained in clinical routine or for&#xD;
        the IIP registry will be used for this project.&#xD;
  &#xD;
        The aim is to assess changes in self-efficacy and quality of life over time and to establish&#xD;
        a control cohort for a later feasibility study on a educational and self-management&#xD;
        intervention (currently in planning).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 20, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2024</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>Change in Self-efficacy</measure>
      <time_frame>From t0 to t2 (60-120 days after t0)</time_frame>
      <description>Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) tool</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Self-efficacy</measure>
      <time_frame>From t0 to t1 (14-40 days after t0)</time_frame>
      <description>Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) tool</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in health related quality of life</measure>
      <time_frame>From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0)</time_frame>
      <description>King's Brief Interstitial Lung Disease (K-BILD) health status questionnaire,</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in functional status</measure>
      <time_frame>From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0)</time_frame>
      <description>King's Brief Interstitial Lung Disease (K-BILD) health status questionnaire,</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in self-reported health status</measure>
      <time_frame>From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0)</time_frame>
      <description>EQ-VAS Score</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in self-reported symptoms</measure>
      <time_frame>From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0)</time_frame>
      <description>Leicester Cough Questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in self-reported anxiety and depression</measure>
      <time_frame>From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0)</time_frame>
      <description>Hospital Anxiety and Depression Scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Supplemental oxygen needs for activity and at rest</measure>
      <time_frame>t0, t1 (14-40 days after t0) and t2 (60-120 days after t0)</time_frame>
      <description>routinely collected data</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Re-hospitalization and survival</measure>
      <time_frame>from t0 to t2 (60-120 days after t0)</time_frame>
      <description>routinely collected data</description>
    </secondary_outcome>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Interstitial Lung Disease</condition>
    <condition>Fibrotic Lung Disease</condition>
    <condition>Self Efficacy</condition>
    <condition>Self-management</condition>
    <condition>Patient Education</condition>
    <condition>Quality of Life</condition>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>inpatient rehabilitation</intervention_name>
      <description>This is an uncontrolled observational study on patients undergoing usual care in pulmonary rehabilitation and care</description>
      <other_name>outpatient consultations for interstitial lung disease</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with fibrotic lung disease participating in an inpatient rehabilitation or in&#xD;
          outpatient consultations for interstitial lung disease&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion criteria are:&#xD;
  &#xD;
          1a. For Berner Reha Zentrum only: Diagnosis of a FILD as major indication for pulmonary&#xD;
          rehabilitation&#xD;
  &#xD;
          1b. For Inselspital only: Enrolled in Idiopathic interstitial Pneumonia (IIP) cohort study&#xD;
          (Nr. 246/15 / PB_2016-01524) and agreed to further use of data for further research purpose&#xD;
          2. Age ≥ 18 years 3. Written informed consent&#xD;
  &#xD;
          Exclusion criteria are:&#xD;
  &#xD;
            1. Cognitive inability or insufficient knowledge of project language (German) to follow&#xD;
               informed consent or study procedures&#xD;
  &#xD;
            2. Sarcoidosis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Thimo Marcin, PhD</last_name>
      <phone>+41 33 244 30 48</phone>
      <email>t.marcin@rehabern.ch</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Thomas Riegler, Msc</last_name>
      <email>riel@zhaw.ch</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Berner Reha Zentrum, Rehabilitation &amp; Sports Medicine, Insel Group, University Hospital Berne</name>
        <address>
          <city>Bern</city>
          <state>Heiligenschwendi</state>
          <zip>3365</zip>
          <country>Switzerland</country>
        </address>
      </facility>
      <contact>
        <last_name>Thimo Marcin, PhD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Department of Pulmonary Medicine, Inselspital, Bern University Hospital, University of Bern</name>
        <address>
          <city>Bern</city>
          <zip>3010</zip>
          <country>Switzerland</country>
        </address>
      </facility>
      <contact>
        <last_name>Sabina Guler, PD MD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>self efficacy</keyword>
    <keyword>self-management</keyword>
    <keyword>patient education</keyword>
    <keyword>well-beeing</keyword>
    <keyword>quality of life</keyword>
    <keyword>fibrotic lung disease</keyword>
    <keyword>interstitial lung disease</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Diseases</mesh_term>
      <mesh_term>Lung Diseases, Interstitial</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06027333
  org study id: BernerRehaZentrum
  nct id: NCT06027333
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Patients with fibrotic insterstitial lung disease (ILD) participating in inpatient
        rehabilitation or in outpatient pulmonary care will be invited to participate in this
        observational study. Patients will fill out questionnaire regarding quality of life and
        symptoms at baseline and follow-up (at the end of rehabilitation or after the second
        outpatient ILD consultation). Additionally, clinical data obtained in clinical routine or for
        the IIP registry will be used for this project.
  
        The aim is to assess changes in self-efficacy and quality of life over time and to establish
        a control cohort for a later feasibility study on a educational and self-management
        intervention (currently in planning).
  observational model: Cohort
  time perspective: Prospective
  measure: Change in Self-efficacy
  time frame: From t0 to t2 (60-120 days after t0)
  description: Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) tool
  measure: Change in Self-efficacy
  time frame: From t0 to t1 (14-40 days after t0)
  description: Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) tool
  measure: Change in health related quality of life
  time frame: From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0)
  description: King's Brief Interstitial Lung Disease (K-BILD) health status questionnaire,
  measure: Change in functional status
  time frame: From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0)
  description: King's Brief Interstitial Lung Disease (K-BILD) health status questionnaire,
  measure: Change in self-reported health status
  time frame: From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0)
  description: EQ-VAS Score
  measure: Change in self-reported symptoms
  time frame: From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0)
  description: Leicester Cough Questionnaire
  measure: Change in self-reported anxiety and depression
  time frame: From t0 to t1 (14-40 days after t0) and from t0 to t2 (60-120 days after t0)
  description: Hospital Anxiety and Depression Scale
  measure: Supplemental oxygen needs for activity and at rest
  time frame: t0, t1 (14-40 days after t0) and t2 (60-120 days after t0)
  description: routinely collected data
  measure: Re-hospitalization and survival
  time frame: from t0 to t2 (60-120 days after t0)
  description: routinely collected data
  intervention type: Behavioral
  intervention name: inpatient rehabilitation
  description: This is an uncontrolled observational study on patients undergoing usual care in pulmonary rehabilitation and care
  other name: outpatient consultations for interstitial lung disease
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Thimo Marcin, PhD
  phone: +41 33 244 30 48
  email: t.marcin@rehabern.ch
  last name: Thomas Riegler, Msc
  email: riel@zhaw.ch
  facility: 
  contact: 
  facility: 
  contact: 
  country: Switzerland
  responsible party type: Sponsor
  mesh term: Lung Diseases
  mesh term: Lung Diseases, Interstitial
  sharing ipd: Undecided