<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/NCT04428957</url>
  </required_header>
  <id_info>
    <org_study_id>RNN/50/20/KE</org_study_id>
    <secondary_id>0047/DW/2018</secondary_id>
    <nct_id>NCT04428957</nct_id>
  </id_info>
  <brief_title>Telemonitoring of Treatment Effects in Connective Tissue Disease-associated Interstitial Lung Disease (TEL-CTD-ILD)</brief_title>
  <acronym>TEL-CTD-ILD</acronym>
  <official_title>Telemonitoring as a Tool for the Assessment of Treatment Effects of Connective Tissue Disease-associated Interstitial Lung Disease (TEL-CTD-ILD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Lodz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Lodz</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>
      1. Impact of telemonitoring on quality of life (QoL) of patients with CTD-ILD&#xD;
&#xD;
        2. Evaluation of health status of patients with connective tissue disease-associated&#xD;
           interstitial lung disease (CTD-ILD) using telemonitoring and standard care.&#xD;
&#xD;
        3. Assessment of treatment response patterns (full remission, partial remission,&#xD;
           progression, no response) and evaluation of clinical prognostic factors (risk factors&#xD;
           for poor response in patients with CTD-ILD.&#xD;
&#xD;
        4. Evaluation of cost-effectiveness of telemonitoring solutions in patients with CTD-ILD.&#xD;
&#xD;
        5. Evaluation of telemedicine as a tool for assessing the safety of therapy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Interstitial lung disease (ILD) is one of the most serious pulmonary complications related to&#xD;
      connective tissue diseases (CTDs), resulting in substantial morbidity and mortality.&#xD;
      Interstitial lung disease is a common manifestation of different connective tissue diseases,&#xD;
      such as scleroderma, rheumatoid arthritis (RA), Sjögren's syndrome, systemic lupus,&#xD;
      dermatomyositis and others. Radiological and histopathological patterns are most often&#xD;
      nonspecific interstitial pneumonia (NSIP), organizing pneumonia (OP), usual interstitial&#xD;
      pneumonia (UIP) and lymphocytic interstitial pneumonia (LIP).&#xD;
&#xD;
      Current standard of care in progressive CTD associated ILD is low to medium dose of&#xD;
      corticosteroids, frequently combined with immunosuppressive medication, depending on disease&#xD;
      severity and local standards. However, based on clinical and radiological features, it is&#xD;
      difficult to predict what will be the response to the treatment. Effectiveness of the&#xD;
      treatment is assessed by functional tests and chest high resolution computed tomography&#xD;
      (HRCT), performed usually after 3 months of therapy.&#xD;
&#xD;
      Project objective is to assess the possible benefits of using telemonitoring of functional&#xD;
      and vital signs, symptoms and quality of life of patients with CTD-ILD in response to&#xD;
      treatment.&#xD;
&#xD;
      In the trial patients diagnosed with CTD-ILD will be randomized to intervention group&#xD;
      (telemonitoring) and the control group (traditional assessment). Patients from the study&#xD;
      after initial training will perform daily spirometry (FVC), transdermal pulse oximetry, pulse&#xD;
      and blood pressure measurements, activity measurement (accelerometry), and assessment of&#xD;
      severity of cough and dyspnea. The additional questionnaires will also be used to assess the&#xD;
      tolerability of treatment, quality of life and the occurrence of side effects. Telemonitoring&#xD;
      will start 10 to 14 days before the start of treatment and will be carried out for 3 months&#xD;
      of therapy. All patients (study and control group) will receive treatment in accordance with&#xD;
      current treatment standards. During the 3-month observation period, visits to the center will&#xD;
      take place at monthly intervals. In the case of treatment intolerance or deterioration of&#xD;
      monitored parameters, patients will be evaluated at additional time points. All patients&#xD;
      after the end of the 3-month follow-up will remain under the care of the Pulmonology Clinic&#xD;
      and will be examined during regular visits every 3 months until the end of the 12-month&#xD;
      follow-up period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 11, 2020</start_date>
  <completion_date type="Anticipated">April 2022</completion_date>
  <primary_completion_date type="Anticipated">April 2022</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline health-related quality of life using EQ-5D-5L questionnaire at 3 months</measure>
    <time_frame>at baseline, after 3 months</time_frame>
    <description>The EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L) questionnaire will be used for the assessment of quality of life. The EQ-5D-5L essentially consists of 2 pages - the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L is especially suited to cost effectiveness analyses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline health-related quality of life using St. George's Respiratory Questionnaire at 3 months</measure>
    <time_frame>at baseline, after 3 months</time_frame>
    <description>St. George's Respiratory Questionnaire (SGRQ) will be used to assess health related quality-of-life. The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. SGRQ is survey with scores ranging from 0 to 100 and with higher scores indicating worse quality of life.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Costs of health service utilization in Polish zloty</measure>
    <time_frame>after 3 months, after 6 months</time_frame>
    <description>Mean costs in telemonitoring and control group will be estimated. Healthcare utilization will be assessed through the number of emergency department, hospital or outpatient clinic visits, medications and adverse events treatments. Resource use categories will be monetarily valued using unit cost and multiplied with the collected amount of resource use. Mean costs in Polish zloty per group will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Dyspnea using Modified Medical Research Council (mMRC)</measure>
    <time_frame>at baseline, after 3 months</time_frame>
    <description>The Modified Medical Research Council Dyspnea (mMRC) scale will be used to determine functional impairment due to dyspnea. It is a five-level rating scale consisting of just five items containing statements about the impact of dyspnea on the patients' daily activities performance. Higher scores indicate a greater impact of dyspnea on the patients' daily activities performance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of fatigue using Fatigue Assessment Scale (FAS)</measure>
    <time_frame>at baseline, after 3 months</time_frame>
    <description>Fatigue Assessment Scale (FAS) will be used for assessment of fatigue status. The total score ranges from 10 to 50. A total FAS score &lt; 22 indicates no fatigue, a score ≥ 22 indicates fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of patients' adherence to recommended medications using the Adherence Scale in Chronic Diseases (ASCD)</measure>
    <time_frame>at baseline, after 3 months</time_frame>
    <description>The Adherence Scale in Chronic Diseases is a self-reported questionnaire with 8 items and with proposed 5 sets of answers. The total score in the Adherence Scale in Chronic Diseases ranges from 0 to 32 points. Three levels of adherence were considered (low: scores of 0 to 20; medium 21 to 25; high &gt; 26).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline anxiety and depression symptoms as measured by HADS (Hospital Anxiety and Depression Scale)</measure>
    <time_frame>at baseline, after 3 months</time_frame>
    <description>The Hospital Depression and Anxiety Index (HADS) is a 14-item survey with scores ranging from 0 to 21 and with higher scores indicating greater depression and anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline depression as measured by PHQ-9</measure>
    <time_frame>at baseline, after 3 months</time_frame>
    <description>The Patient Health Questionnaire (PHQ-9) is a 10-item survey with scores ranging from 1 to 27 and with higher scores indicating greater levels of depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For the telemonitoring arm, oxygen saturation (SpO2) expressed in percent</measure>
    <time_frame>twice a day day from baseline for 3 months</time_frame>
    <description>Oxygen saturation level (SpO2) will be measured by transdermal Pulse Oximeter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For the telemonitoring arm, heart rate (HR) expressed in beats per minute (bpm)</measure>
    <time_frame>twice a day day from baseline for 3 months</time_frame>
    <description>Heart rate home telemonitoring consisted of twice-daily patient self-measurement of heart rate with automated device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For the telemonitoring arm, systolic blood pressure (SBP) expressed in mmHg</measure>
    <time_frame>twice a day day from baseline for 3 months</time_frame>
    <description>Systolic BP will be assessed by home-based blood pressure telemonitoring using sphygmomanometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For the telemonitoring arm, diastolic blood pressure (DBP) expressed in mmHg</measure>
    <time_frame>twice a day day from baseline for 3 months</time_frame>
    <description>Diastolic BP will be assessed by home-based blood pressure telemonitoring using sphygmomanometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For the telemonitoring arm, forced vital capacity (FVC) expressed in percent</measure>
    <time_frame>twice a day day from baseline for 3 months</time_frame>
    <description>Lung function like forced vital capacity (FVC, %FVC) will be assessed using home spirometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For the telemonitoring arm, forced expiratory volume in 1st second (FEV1) expressed in percent</measure>
    <time_frame>twice a day day from baseline for 3 months</time_frame>
    <description>Lung function like forced expiratory volume in 1 second (FEV1, ％FEV1) will be assessed using home spirometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For the telemonitoring arm, patient's satisfaction assessed by developed telemonitoring satisfaction survey.</measure>
    <time_frame>after 3 months</time_frame>
    <description>Developed telemonitoring satisfaction survey will be used for the assessment of patient's satisfaction in 10 areas assessed using the 5-point Likert scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For the telemonitoring arm, cough severity measured using 5-point Likert scale (range 0-4)</measure>
    <time_frame>twice a day day from baseline for 3 months</time_frame>
    <description>A 5-point Likert scale will be used to measure cough severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For the telemonitoring arm, dyspnea severity measured using a 5-point Likert scale (range 0-4)</measure>
    <time_frame>twice a day day from baseline for 3 months</time_frame>
    <description>A 5-point Likert scale will be used to measure dyspnea severity</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Connective Tissue Disease-associated Interstitial Lung Disease</condition>
  <condition>Interstitial Lung Disease</condition>
  <condition>Connective Tissue Diseases</condition>
  <arm_group>
    <arm_group_label>Telemonitoring group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 months home-based telemonitoring</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>3 months standard care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Telemonitoring</intervention_name>
    <description>Daily telemonitoring of heart rate (HR), blood pressure (BP), pulse oximetry (SpO2), spirometry (FVC), activity (accelerometry) and severity of cough and dyspnea</description>
    <arm_group_label>Telemonitoring group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnosed interstitial lung disease with a small component of fibrous changes;&#xD;
&#xD;
          -  Indications for systemic glucocorticoid therapy +/- immunosuppressant;&#xD;
&#xD;
          -  18 years and older&#xD;
&#xD;
          -  Informed consent to participate in the study;&#xD;
&#xD;
          -  Effective contraception;&#xD;
&#xD;
          -  Result of the Mini Mental test ensuring the possibility of efficient operation of&#xD;
             monitoring devices;&#xD;
&#xD;
          -  Completed training in the operation of telemedicine equipment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of irreversible interstitial fibrotic changes in lung HRCT;&#xD;
&#xD;
          -  Pattern of definite or probable usual interstitial pneumonia (UIP) in the HRCT&#xD;
             examination;&#xD;
&#xD;
          -  Contraindications to glucocorticoid and immunosuppressive therapy (azathioprine or&#xD;
             mycophenolate mofetil or cyclophosphamide or cyclosporine);&#xD;
&#xD;
          -  Pregnancy and breast-feeding.&#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>Wojciech Piotrowski, Assoc. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Pneumology and Allergy, Medical University of Lodz</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sylwia Małysiak-Szpond, MSc</last_name>
    <phone>+48519515038</phone>
    <email>sylwia.malysiak-szpond@stud.umed.lodz.pl</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Pneumology and Allergy, Medical University of Lodz</name>
      <address>
        <city>Łódź</city>
        <state>Lodz Province</state>
        <zip>90-153</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Mozga, MD</last_name>
      <email>maria.mozga@umed.lodz.pl</email>
    </contact>
    <investigator>
      <last_name>Wojciech Piotrowski, Assoc. Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Joanna Miłkowska-Dymanowska, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>April 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Telemonitoring</keyword>
  <keyword>Telemedicine</keyword>
  <keyword>Interstitial lung disease</keyword>
  <keyword>Connective Tissue Diseases</keyword>
  <keyword>Treatment</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>
    <mesh_term>Connective Tissue Diseases</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/NCT04428957
org study id: RNN/50/20/KE
secondary id: 0047/DW/2018
nct id: NCT04428957
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
1. Impact of telemonitoring on quality of life (QoL) of patients with CTD-ILD

        2. Evaluation of health status of patients with connective tissue disease-associated
           interstitial lung disease (CTD-ILD) using telemonitoring and standard care.

        3. Assessment of treatment response patterns (full remission, partial remission,
           progression, no response) and evaluation of clinical prognostic factors (risk factors
           for poor response in patients with CTD-ILD.

        4. Evaluation of cost-effectiveness of telemonitoring solutions in patients with CTD-ILD.

        5. Evaluation of telemedicine as a tool for assessing the safety of therapy
Interstitial lung disease (ILD) is one of the most serious pulmonary complications related to
      connective tissue diseases (CTDs), resulting in substantial morbidity and mortality.
      Interstitial lung disease is a common manifestation of different connective tissue diseases,
      such as scleroderma, rheumatoid arthritis (RA), Sjögren's syndrome, systemic lupus,
      dermatomyositis and others. Radiological and histopathological patterns are most often
      nonspecific interstitial pneumonia (NSIP), organizing pneumonia (OP), usual interstitial
      pneumonia (UIP) and lymphocytic interstitial pneumonia (LIP).

      Current standard of care in progressive CTD associated ILD is low to medium dose of
      corticosteroids, frequently combined with immunosuppressive medication, depending on disease
      severity and local standards. However, based on clinical and radiological features, it is
      difficult to predict what will be the response to the treatment. Effectiveness of the
      treatment is assessed by functional tests and chest high resolution computed tomography
      (HRCT), performed usually after 3 months of therapy.

      Project objective is to assess the possible benefits of using telemonitoring of functional
      and vital signs, symptoms and quality of life of patients with CTD-ILD in response to
      treatment.

      In the trial patients diagnosed with CTD-ILD will be randomized to intervention group
      (telemonitoring) and the control group (traditional assessment). Patients from the study
      after initial training will perform daily spirometry (FVC), transdermal pulse oximetry, pulse
      and blood pressure measurements, activity measurement (accelerometry), and assessment of
      severity of cough and dyspnea. The additional questionnaires will also be used to assess the
      tolerability of treatment, quality of life and the occurrence of side effects. Telemonitoring
      will start 10 to 14 days before the start of treatment and will be carried out for 3 months
      of therapy. All patients (study and control group) will receive treatment in accordance with
      current treatment standards. During the 3-month observation period, visits to the center will
      take place at monthly intervals. In the case of treatment intolerance or deterioration of
      monitored parameters, patients will be evaluated at additional time points. All patients
      after the end of the 3-month follow-up will remain under the care of the Pulmonology Clinic
      and will be examined during regular visits every 3 months until the end of the 12-month
      follow-up period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change from baseline health-related quality of life using EQ-5D-5L questionnaire at 3 months
time frame: at baseline, after 3 months
description: The EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L) questionnaire will be used for the assessment of quality of life. The EQ-5D-5L essentially consists of 2 pages - the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L is especially suited to cost effectiveness analyses.
measure: Change from baseline health-related quality of life using St. George's Respiratory Questionnaire at 3 months
time frame: at baseline, after 3 months
description: St. George's Respiratory Questionnaire (SGRQ) will be used to assess health related quality-of-life. The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. SGRQ is survey with scores ranging from 0 to 100 and with higher scores indicating worse quality of life.
measure: Costs of health service utilization in Polish zloty
time frame: after 3 months, after 6 months
description: Mean costs in telemonitoring and control group will be estimated. Healthcare utilization will be assessed through the number of emergency department, hospital or outpatient clinic visits, medications and adverse events treatments. Resource use categories will be monetarily valued using unit cost and multiplied with the collected amount of resource use. Mean costs in Polish zloty per group will be calculated.
measure: Assessment of Dyspnea using Modified Medical Research Council (mMRC)
time frame: at baseline, after 3 months
description: The Modified Medical Research Council Dyspnea (mMRC) scale will be used to determine functional impairment due to dyspnea. It is a five-level rating scale consisting of just five items containing statements about the impact of dyspnea on the patients' daily activities performance. Higher scores indicate a greater impact of dyspnea on the patients' daily activities performance.
measure: Assessment of fatigue using Fatigue Assessment Scale (FAS)
time frame: at baseline, after 3 months
description: Fatigue Assessment Scale (FAS) will be used for assessment of fatigue status. The total score ranges from 10 to 50. A total FAS score < 22 indicates no fatigue, a score ≥ 22 indicates fatigue.
measure: Assessment of patients' adherence to recommended medications using the Adherence Scale in Chronic Diseases (ASCD)
time frame: at baseline, after 3 months
description: The Adherence Scale in Chronic Diseases is a self-reported questionnaire with 8 items and with proposed 5 sets of answers. The total score in the Adherence Scale in Chronic Diseases ranges from 0 to 32 points. Three levels of adherence were considered (low: scores of 0 to 20; medium 21 to 25; high > 26).
measure: Change from baseline anxiety and depression symptoms as measured by HADS (Hospital Anxiety and Depression Scale)
time frame: at baseline, after 3 months
description: The Hospital Depression and Anxiety Index (HADS) is a 14-item survey with scores ranging from 0 to 21 and with higher scores indicating greater depression and anxiety.
measure: Change from baseline depression as measured by PHQ-9
time frame: at baseline, after 3 months
description: The Patient Health Questionnaire (PHQ-9) is a 10-item survey with scores ranging from 1 to 27 and with higher scores indicating greater levels of depression.
measure: For the telemonitoring arm, oxygen saturation (SpO2) expressed in percent
time frame: twice a day day from baseline for 3 months
description: Oxygen saturation level (SpO2) will be measured by transdermal Pulse Oximeter.
measure: For the telemonitoring arm, heart rate (HR) expressed in beats per minute (bpm)
time frame: twice a day day from baseline for 3 months
description: Heart rate home telemonitoring consisted of twice-daily patient self-measurement of heart rate with automated device.
measure: For the telemonitoring arm, systolic blood pressure (SBP) expressed in mmHg
time frame: twice a day day from baseline for 3 months
description: Systolic BP will be assessed by home-based blood pressure telemonitoring using sphygmomanometer
measure: For the telemonitoring arm, diastolic blood pressure (DBP) expressed in mmHg
time frame: twice a day day from baseline for 3 months
description: Diastolic BP will be assessed by home-based blood pressure telemonitoring using sphygmomanometer
measure: For the telemonitoring arm, forced vital capacity (FVC) expressed in percent
time frame: twice a day day from baseline for 3 months
description: Lung function like forced vital capacity (FVC, %FVC) will be assessed using home spirometry.
measure: For the telemonitoring arm, forced expiratory volume in 1st second (FEV1) expressed in percent
time frame: twice a day day from baseline for 3 months
description: Lung function like forced expiratory volume in 1 second (FEV1, ％FEV1) will be assessed using home spirometry.
measure: For the telemonitoring arm, patient's satisfaction assessed by developed telemonitoring satisfaction survey.
time frame: after 3 months
description: Developed telemonitoring satisfaction survey will be used for the assessment of patient's satisfaction in 10 areas assessed using the 5-point Likert scale.
measure: For the telemonitoring arm, cough severity measured using 5-point Likert scale (range 0-4)
time frame: twice a day day from baseline for 3 months
description: A 5-point Likert scale will be used to measure cough severity
measure: For the telemonitoring arm, dyspnea severity measured using a 5-point Likert scale (range 0-4)
time frame: twice a day day from baseline for 3 months
description: A 5-point Likert scale will be used to measure dyspnea severity
arm group label: Telemonitoring group
arm group type: Experimental
description: 3 months home-based telemonitoring
arm group label: Control group
arm group type: No Intervention
description: 3 months standard care
intervention type: Other
intervention name: Telemonitoring
description: Daily telemonitoring of heart rate (HR), blood pressure (BP), pulse oximetry (SpO2), spirometry (FVC), activity (accelerometry) and severity of cough and dyspnea
arm group label: Telemonitoring group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wojciech Piotrowski, Assoc. Prof.
role: Principal Investigator
affiliation: Department of Pneumology and Allergy, Medical University of Lodz
last name: Sylwia Małysiak-Szpond, MSc
phone: +48519515038
email: sylwia.malysiak-szpond@stud.umed.lodz.pl
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Poland
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Interstitial
mesh term: Connective Tissue Diseases
sharing ipd: No