<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/NCT04457843</url>
  </required_header>
  <id_info>
    <org_study_id>mCST - Kaia App</org_study_id>
    <nct_id>NCT04457843</nct_id>
  </id_info>
  <brief_title>The Mobile COPD Status Test (mCST)</brief_title>
  <official_title>The Mobile COPD Status Test (mCST) - Investigation of the Correlation of a Digital Measurement With Disease Relevant Endpoints in Patients With COPD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Schön Klinik Berchtesgadener Land</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Schön Klinik Berchtesgadener Land</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Up tp now, disease activity of COPD patients in their home environment has usually been&#xD;
      recorded by questionnaires (e.g. COPD assessment test). Digital multifactorial measurements,&#xD;
      via the &quot;mobile COPD Status test&quot; app, offer a new way of displaying disease activity.&#xD;
      However, there is no independent study that has examined whether digitally collected&#xD;
      parameters correlate with the common used measurement instruments for COPD patients (both in&#xD;
      cross-sectional and longitudinal course).&#xD;
&#xD;
      The aim of this exploratory study is to investigate the correlation between the mobile COPD&#xD;
      Status test (mCST App, KAIA Health) and a conventional collected clinical data set of routine&#xD;
      measurements as well as the subjective symptoms and activity perception of COPD patients in&#xD;
      their home environment, with and without exacerbation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In total 130 COPD patients will be included prospectively in this multicenter trial during an&#xD;
      inpatient pulmonary rehabilitation program at the Schoen Klinik Berchtesgadener Land, Schönau&#xD;
      am Koenigssee, (Germany) or during a stay (inpatient or outpatient) at the Klinikum Nuremberg&#xD;
      (Germany).&#xD;
&#xD;
      In general, the study is divided into two parts - study part I, within the duration of the&#xD;
      pulmonary rehabilitation program/ hospital stay and study part II, in the home environment&#xD;
      (24 weeks).&#xD;
&#xD;
      Study part I:&#xD;
&#xD;
      Visit 1 (day 0, in the clinic) + Visit 2* (day 14+/-5, in the clinic/outpatient)&#xD;
&#xD;
      Each study participant is given a smartphone. Under the guidance of study personnel, data&#xD;
      collection of the following parameters is carried out via KAIA mCST App):&#xD;
&#xD;
        -  four standardized questions regarding coughing frequency, expectoration, chest tightness&#xD;
           and shortness of breath during exercise&#xD;
&#xD;
        -  Dyspnea at rest&#xD;
&#xD;
        -  Breath sounds via microphone&#xD;
&#xD;
        -  Inspiration/expiration length via microphone&#xD;
&#xD;
        -  Respiratory rate via smartphone measurements&#xD;
&#xD;
        -  Physical performance via the sit-to-stand test (1min) with counting the repetitions and&#xD;
           checking the correct execution via smartphone camera&#xD;
&#xD;
        -  Gait analysis (2x 10 steps walking) via acceleration sensors of the smartphone or via&#xD;
           motion tracking by camera during defined gait measurements.&#xD;
&#xD;
      The mCST app takes about 15 minutes to complete.&#xD;
&#xD;
      Additionally, clinical routine data will be collected:&#xD;
&#xD;
        -  medical history&#xD;
&#xD;
        -  body plethysmography &amp; blood gases&#xD;
&#xD;
        -  EKG&#xD;
&#xD;
        -  health related quality of life&#xD;
&#xD;
        -  dyspnea&#xD;
&#xD;
        -  6-minute walk distance&#xD;
&#xD;
        -  1-minute-sit to stand test&#xD;
&#xD;
      Study part II:&#xD;
&#xD;
      Visits 3 to 26 (week 3 to 26, in participants home environment) From study visit 3 on,&#xD;
      participants are observed weekly in their home environment for a total of 24 weeks. No&#xD;
      further clinic visits take place. Disease activity is measured weekly as patient reported&#xD;
      outcomes using the mCST app (for details see description of visit 1/2, part 1). In addition&#xD;
      to the weekly mCST app, patients are invited to fill out daily a symptom diary before going&#xD;
      to bed. The symptom diary contains the EXACT questionnaire and an activity questionnaire.&#xD;
&#xD;
      *Visit 2 is optional&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 21, 2020</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Actual">August 16, 2022</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>Correlation between usual physical exercise tests and exercise test measured via mobile COPD status test app (mCST)</measure>
    <time_frame>Visit 1 (Day 0)</time_frame>
    <description>Correlation between the 6-minute walk test distance (clinical routine) and the number of repetitions of the 1-minute sit-to-stand-test (mCST app)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation between usual physical exercise tests and exercise test measured via mobile COPD status test app (mCST)</measure>
    <time_frame>if applicable Visit 2 (Day 14)</time_frame>
    <description>Correlation between the 6-minute walk test distance (clinical routine) and the number of repetitions of the 1-minute sit-to-stand-test (mCST app)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between COPD Assessment test and perception of disease activity measured via mobile COPD status test app (mCST)</measure>
    <time_frame>weekly up to 26 weeks (Visit 1 to Visit 26)</time_frame>
    <description>Correlation between standardized questions about COPD activity/ symptoms via the mCST app and the COPD Assessment Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between modified medical research scale (mMRc) and perception of dyspnea measured via mobile COPD status test app (mCST)</measure>
    <time_frame>Visit 1 (Day 0)</time_frame>
    <description>Correlation between standardized questions about dyspnea collected via the mCST app and the modified medical research scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between modified medical research scale (mMRc) and perception of dyspnea measured via mobile COPD status test app (mCST)</measure>
    <time_frame>if applicable Visit 2 (Day 14)</time_frame>
    <description>Correlation between standardized questions about dyspnea collected via the mCST app and the modified medical research scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between lung function parameters and inspiratory-/expiratory duration measured via mobile COPD status test app (mCST)</measure>
    <time_frame>Visit 1 (Day 0)</time_frame>
    <description>Correlation between inspiratory-/ expiratory duration via the mCST app and FEV1, RV, TLC, VC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between lung function parameters and inspiratory-/expiratory duration measured via mobile COPD status test app (mCST)</measure>
    <time_frame>if applicable Visit 2 (Day 14)</time_frame>
    <description>Correlation between inspiratory-/ expiratory duration via the mCST app and FEV1, RV, TLC, VC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between mCST app and symptom diary (EXACT questionnaire)</measure>
    <time_frame>weekly up to 26 weeks (Visit 1 to Visit 26)</time_frame>
    <description>Correlation between standardized questions about COPD activity/symptoms via the mCST app and the EXACT questionnaire, which consists of 14 questions to quantify exacerbations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between mCST app and symptom diary (Freiburger activity questionnaire)</measure>
    <time_frame>weekly up to 26 weeks (Visit 1 to Visit 26)</time_frame>
    <description>Correlation between standardized questions about COPD activity/ symptoms via the mCST app and the Freiburger activity questionnaire, which consists of 12 items and measures the duration and frequency of various basic, everyday and sports activities of the past week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in outcomes of the mobile COPD status test app (mCST) between patients without and with exacerbations during the study period</measure>
    <time_frame>weekly up to 26 weeks (Visit 1 to Visit 26)</time_frame>
    <description>Change in the mCST app parameters during the trial period in stable COPD patients an COPD patients with an acute exacerbations during the study period</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>COPD patients</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>usual medical care</intervention_name>
    <description>Prospective monitoring of clinical Outcomes and digital collected outcomes via the mobile COPD staus test app.</description>
    <arm_group_label>COPD patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        COPD patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  hospitalisation at Schoen Klinik Berchtesgadener Land or Klinikum Nuremberg&#xD;
&#xD;
          -  Chronic obstructive pulmonary disease GOLD A-D&#xD;
&#xD;
          -  sufficient german language and samrtphone skills to understand the mCST app&#xD;
&#xD;
          -  sufficient good WLAN Connection in the domestic environment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence of comorbidities which could interfere the course of the trial (e.g.&#xD;
             cognitive deficits, neurological or orthopedic diseases)&#xD;
&#xD;
          -  significant mental illness, legal incapacity or limited legal capacity&#xD;
&#xD;
          -  patients who are unable or unwilling to perform the study activities acording to the&#xD;
             protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Klinikum Nürnberg, Klinik für Innere Medizin3, Schwerpunkt Pneumologie</name>
      <address>
        <city>Nürnberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Berchtesgadener Land, Schön Kliniken</name>
      <address>
        <city>Schönau am Königssee</city>
        <zip>83471</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>March 8, 2023</last_update_submitted>
  <last_update_submitted_qc>March 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Schön Klinik Berchtesgadener Land</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Andreas Rembert Koczulla</investigator_full_name>
    <investigator_title>Professor for pulmonary rehabilitation</investigator_title>
  </responsible_party>
  <keyword>Telehealth</keyword>
  <keyword>disease progression</keyword>
  <keyword>disease activity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</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/NCT04457843
org study id: mCST - Kaia App
nct id: NCT04457843
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Up tp now, disease activity of COPD patients in their home environment has usually been
      recorded by questionnaires (e.g. COPD assessment test). Digital multifactorial measurements,
      via the "mobile COPD Status test" app, offer a new way of displaying disease activity.
      However, there is no independent study that has examined whether digitally collected
      parameters correlate with the common used measurement instruments for COPD patients (both in
      cross-sectional and longitudinal course).

      The aim of this exploratory study is to investigate the correlation between the mobile COPD
      Status test (mCST App, KAIA Health) and a conventional collected clinical data set of routine
      measurements as well as the subjective symptoms and activity perception of COPD patients in
      their home environment, with and without exacerbation.
In total 130 COPD patients will be included prospectively in this multicenter trial during an
      inpatient pulmonary rehabilitation program at the Schoen Klinik Berchtesgadener Land, Schönau
      am Koenigssee, (Germany) or during a stay (inpatient or outpatient) at the Klinikum Nuremberg
      (Germany).

      In general, the study is divided into two parts - study part I, within the duration of the
      pulmonary rehabilitation program/ hospital stay and study part II, in the home environment
      (24 weeks).

      Study part I:

      Visit 1 (day 0, in the clinic) + Visit 2* (day 14+/-5, in the clinic/outpatient)

      Each study participant is given a smartphone. Under the guidance of study personnel, data
      collection of the following parameters is carried out via KAIA mCST App):

        -  four standardized questions regarding coughing frequency, expectoration, chest tightness
           and shortness of breath during exercise

        -  Dyspnea at rest

        -  Breath sounds via microphone

        -  Inspiration/expiration length via microphone

        -  Respiratory rate via smartphone measurements

        -  Physical performance via the sit-to-stand test (1min) with counting the repetitions and
           checking the correct execution via smartphone camera

        -  Gait analysis (2x 10 steps walking) via acceleration sensors of the smartphone or via
           motion tracking by camera during defined gait measurements.

      The mCST app takes about 15 minutes to complete.

      Additionally, clinical routine data will be collected:

        -  medical history

        -  body plethysmography & blood gases

        -  EKG

        -  health related quality of life

        -  dyspnea

        -  6-minute walk distance

        -  1-minute-sit to stand test

      Study part II:

      Visits 3 to 26 (week 3 to 26, in participants home environment) From study visit 3 on,
      participants are observed weekly in their home environment for a total of 24 weeks. No
      further clinic visits take place. Disease activity is measured weekly as patient reported
      outcomes using the mCST app (for details see description of visit 1/2, part 1). In addition
      to the weekly mCST app, patients are invited to fill out daily a symptom diary before going
      to bed. The symptom diary contains the EXACT questionnaire and an activity questionnaire.

      *Visit 2 is optional
observational model: Cohort
time perspective: Prospective
measure: Correlation between usual physical exercise tests and exercise test measured via mobile COPD status test app (mCST)
time frame: Visit 1 (Day 0)
description: Correlation between the 6-minute walk test distance (clinical routine) and the number of repetitions of the 1-minute sit-to-stand-test (mCST app)
measure: Correlation between usual physical exercise tests and exercise test measured via mobile COPD status test app (mCST)
time frame: if applicable Visit 2 (Day 14)
description: Correlation between the 6-minute walk test distance (clinical routine) and the number of repetitions of the 1-minute sit-to-stand-test (mCST app)
measure: Correlation between COPD Assessment test and perception of disease activity measured via mobile COPD status test app (mCST)
time frame: weekly up to 26 weeks (Visit 1 to Visit 26)
description: Correlation between standardized questions about COPD activity/ symptoms via the mCST app and the COPD Assessment Test
measure: Correlation between modified medical research scale (mMRc) and perception of dyspnea measured via mobile COPD status test app (mCST)
time frame: Visit 1 (Day 0)
description: Correlation between standardized questions about dyspnea collected via the mCST app and the modified medical research scale
measure: Correlation between modified medical research scale (mMRc) and perception of dyspnea measured via mobile COPD status test app (mCST)
time frame: if applicable Visit 2 (Day 14)
description: Correlation between standardized questions about dyspnea collected via the mCST app and the modified medical research scale
measure: Correlation between lung function parameters and inspiratory-/expiratory duration measured via mobile COPD status test app (mCST)
time frame: Visit 1 (Day 0)
description: Correlation between inspiratory-/ expiratory duration via the mCST app and FEV1, RV, TLC, VC
measure: Correlation between lung function parameters and inspiratory-/expiratory duration measured via mobile COPD status test app (mCST)
time frame: if applicable Visit 2 (Day 14)
description: Correlation between inspiratory-/ expiratory duration via the mCST app and FEV1, RV, TLC, VC
measure: Correlation between mCST app and symptom diary (EXACT questionnaire)
time frame: weekly up to 26 weeks (Visit 1 to Visit 26)
description: Correlation between standardized questions about COPD activity/symptoms via the mCST app and the EXACT questionnaire, which consists of 14 questions to quantify exacerbations.
measure: Correlation between mCST app and symptom diary (Freiburger activity questionnaire)
time frame: weekly up to 26 weeks (Visit 1 to Visit 26)
description: Correlation between standardized questions about COPD activity/ symptoms via the mCST app and the Freiburger activity questionnaire, which consists of 12 items and measures the duration and frequency of various basic, everyday and sports activities of the past week
measure: Differences in outcomes of the mobile COPD status test app (mCST) between patients without and with exacerbations during the study period
time frame: weekly up to 26 weeks (Visit 1 to Visit 26)
description: Change in the mCST app parameters during the trial period in stable COPD patients an COPD patients with an acute exacerbations during the study period
arm group label: COPD patients
intervention type: Other
intervention name: usual medical care
description: Prospective monitoring of clinical Outcomes and digital collected outcomes via the mobile COPD staus test app.
arm group label: COPD patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Schön Klinik Berchtesgadener Land
investigator full name: Prof. Dr. Andreas Rembert Koczulla
investigator title: Professor for pulmonary rehabilitation
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive