<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/NCT04453358</url>
  </required_header>
  <id_info>
    <org_study_id>R44MD010177</org_study_id>
    <nct_id>NCT04453358</nct_id>
  </id_info>
  <brief_title>Cystic Fibrosis Remote Monitoring System</brief_title>
  <official_title>Cystic Fibrosis Remote Monitoring System to Support Resource-Limited Communities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Koronis Biomedical Technologies</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Koronis Biomedical Technologies</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to determine if interactive technology (i.e. virtual coaching)&#xD;
      that facilitates vest therapy goal setting and provides positive reinforcement will increase&#xD;
      adherence to vest therapy for airway clearance in individuals with CF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cystic fibrosis (CF) is a life-limiting multi-system disease primarily characterized by&#xD;
      chronic lung infections and pulmonary symptoms such as cough, dyspnea, and chest tightness.&#xD;
      Those with CF rely on numerous pharmaceutical and treatment-based therapies as part of their&#xD;
      routine care to maintain lung health. Airway clearance, one such treatment-based therapy,&#xD;
      uses breathing techniques and various vibrating devices to mobilize lung secretions and is&#xD;
      considered a cornerstone of CF care. Vest therapy, a &quot;shaking vest&quot; that applies pressure and&#xD;
      high frequency vibrations to the chest wall is the most commonly used technique for airway&#xD;
      clearance in the U.S., but adherence to recommended goals for airway clearance is low.&#xD;
      Barriers to adherence include the time limitations and unclear goal setting for effective&#xD;
      treatment. A previous pilot study by this research team showed that CF patients find the use&#xD;
      of airway clearance vests equipped with both pre-set and individually determined programing&#xD;
      capabilities as well as electronic monitoring and transmitting capabilities to be acceptable&#xD;
      and feasible. Information such as vest-use time, vest pressure measures, programming choices&#xD;
      and symptom reporting is captured by these devices and transmitted to health care teams for&#xD;
      review as well as provided to patients to provide feedback on treatment goals. This study&#xD;
      aims to determine if providing patients with clearly stated treatment goals and the means to&#xD;
      monitor and receive positive reinforcing feedback on vest use through interactive technology&#xD;
      (i.e. virtual coaching) will improve vest therapy adherence in individuals with CF.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">August 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2021</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>
    <intervention_model_description>This study is a randomized-comparative study investigating the effectiveness of either low-level virtual coaching vs. high-level virtual coaching in improving airway clearance treatment adherence.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Airway Clearance Therapy Adherence</measure>
    <time_frame>90 days</time_frame>
    <description>Intervention comparison of adherence measurements: a) to prescribed pressure based upon % of time at prescribed pressure and b) to prescribed duration of treatment based upon % of time using the airway clearance device at prescribed duration (weekly capture).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lung Function</measure>
    <time_frame>180 days</time_frame>
    <description>Intervention comparison of pre and post measures of FEV1 and FVC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Measurement</measure>
    <time_frame>180 days</time_frame>
    <description>Intervention comparison based upon pre and post Cystic Fibrosis Questionnaire Revised (CFQ-R).&#xD;
Name of categories/domains CFQ-R:&#xD;
9 Quality of life domains: Physical, role/school, vitality, emotion, social, body image, eating, treatment burden, health perceptions.&#xD;
3 symptom scales: Weight, respiratory, and digestion.&#xD;
Scaling of items:&#xD;
5 distinct 4-point Likert scales (e.g., always/often/ sometime/never)&#xD;
Scoring:&#xD;
Scores for each domain; after recording, each item is summed to generate a domain score and standardized. Scores range from 0 to 100, with higher scores indicating better health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CF Respiratory Symptoms</measure>
    <time_frame>180 days</time_frame>
    <description>Intervention comparison based upon pre and post CF Respiratory Symptom Score (CRSS) assessment.&#xD;
The score evaluates four symptoms: cough, sputum, breathlessness and fatigue. Each symptom is scored from one (mild symptoms) to four (severe symptoms). The total symptom score was the summation of all the four symptoms.&#xD;
Scores range from 4 to 16 with 4 being mild to 16 being most severe.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">35</enrollment>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>Interactive coaching</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Airway clearance therapy using goal setting and interactive feedback.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care coaching</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard of care airway clearance therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>InCourage-Connect</intervention_name>
    <description>This intervention will provide patients with clearly stated treatment goals and provide them with interactive feedback based on usage date to help support airway clearance therapy adherence.</description>
    <arm_group_label>Interactive coaching</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>InCourage</intervention_name>
    <description>This intervention will provide standard of care airway clearance therapy with no interactive feedback on treatment goals and usage.</description>
    <arm_group_label>Standard of care coaching</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a diagnosis of cystic fibrosis&#xD;
&#xD;
          -  Be physically capable of and willing to use the study device&#xD;
&#xD;
          -  Access to an internet connection&#xD;
&#xD;
          -  Access to a mobile device capable of using applications&#xD;
&#xD;
          -  Be familiar with how to utilize a mobile device and/or applications&#xD;
&#xD;
          -  Self-reported CF-related therapy adherence between 25%-75% on a screening&#xD;
             questionnaire&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of solid-organ transplant&#xD;
&#xD;
          -  Inability to speak and read the English language&#xD;
&#xD;
          -  Any contraindication to vest use for airway clearance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Noah Lechtzin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Noah Lechtzin, MD</last_name>
    <phone>(410) 502-7044</phone>
    <email>nlechtz1@jhmi.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Patrick Lichter</last_name>
    <phone>6127301091</phone>
    <email>plichter@koronisbiotech.com</email>
  </overall_contact_backup>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>
  <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/NCT04453358
org study id: R44MD010177
nct id: NCT04453358
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
The objective of this study is to determine if interactive technology (i.e. virtual coaching)
      that facilitates vest therapy goal setting and provides positive reinforcement will increase
      adherence to vest therapy for airway clearance in individuals with CF.
Cystic fibrosis (CF) is a life-limiting multi-system disease primarily characterized by
      chronic lung infections and pulmonary symptoms such as cough, dyspnea, and chest tightness.
      Those with CF rely on numerous pharmaceutical and treatment-based therapies as part of their
      routine care to maintain lung health. Airway clearance, one such treatment-based therapy,
      uses breathing techniques and various vibrating devices to mobilize lung secretions and is
      considered a cornerstone of CF care. Vest therapy, a "shaking vest" that applies pressure and
      high frequency vibrations to the chest wall is the most commonly used technique for airway
      clearance in the U.S., but adherence to recommended goals for airway clearance is low.
      Barriers to adherence include the time limitations and unclear goal setting for effective
      treatment. A previous pilot study by this research team showed that CF patients find the use
      of airway clearance vests equipped with both pre-set and individually determined programing
      capabilities as well as electronic monitoring and transmitting capabilities to be acceptable
      and feasible. Information such as vest-use time, vest pressure measures, programming choices
      and symptom reporting is captured by these devices and transmitted to health care teams for
      review as well as provided to patients to provide feedback on treatment goals. This study
      aims to determine if providing patients with clearly stated treatment goals and the means to
      monitor and receive positive reinforcing feedback on vest use through interactive technology
      (i.e. virtual coaching) will improve vest therapy adherence in individuals with CF.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study is a randomized-comparative study investigating the effectiveness of either low-level virtual coaching vs. high-level virtual coaching in improving airway clearance treatment adherence.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Airway Clearance Therapy Adherence
time frame: 90 days
description: Intervention comparison of adherence measurements: a) to prescribed pressure based upon % of time at prescribed pressure and b) to prescribed duration of treatment based upon % of time using the airway clearance device at prescribed duration (weekly capture).
measure: Lung Function
time frame: 180 days
description: Intervention comparison of pre and post measures of FEV1 and FVC.
measure: Quality of Life Measurement
time frame: 180 days
description: Intervention comparison based upon pre and post Cystic Fibrosis Questionnaire Revised (CFQ-R).
Name of categories/domains CFQ-R:
9 Quality of life domains: Physical, role/school, vitality, emotion, social, body image, eating, treatment burden, health perceptions.
3 symptom scales: Weight, respiratory, and digestion.
Scaling of items:
5 distinct 4-point Likert scales (e.g., always/often/ sometime/never)
Scoring:
Scores for each domain; after recording, each item is summed to generate a domain score and standardized. Scores range from 0 to 100, with higher scores indicating better health.
measure: CF Respiratory Symptoms
time frame: 180 days
description: Intervention comparison based upon pre and post CF Respiratory Symptom Score (CRSS) assessment.
The score evaluates four symptoms: cough, sputum, breathlessness and fatigue. Each symptom is scored from one (mild symptoms) to four (severe symptoms). The total symptom score was the summation of all the four symptoms.
Scores range from 4 to 16 with 4 being mild to 16 being most severe.
arm group label: Interactive coaching
arm group type: Active Comparator
description: Airway clearance therapy using goal setting and interactive feedback.
arm group label: Standard of care coaching
arm group type: Active Comparator
description: Standard of care airway clearance therapy.
intervention type: Device
intervention name: InCourage-Connect
description: This intervention will provide patients with clearly stated treatment goals and provide them with interactive feedback based on usage date to help support airway clearance therapy adherence.
arm group label: Interactive coaching
intervention type: Device
intervention name: InCourage
description: This intervention will provide standard of care airway clearance therapy with no interactive feedback on treatment goals and usage.
arm group label: Standard of care coaching
criteria: 
gender: All
minimum age: 14 Years
maximum age: 85 Years
healthy volunteers: No
last name: Noah Lechtzin, MD
role: Principal Investigator
affiliation: Johns Hopkins University
last name: Noah Lechtzin, MD
phone: (410) 502-7044
email: nlechtz1@jhmi.edu
last name: Patrick Lichter
phone: 6127301091
email: plichter@koronisbiotech.com
responsible party type: Sponsor
mesh term: Cystic Fibrosis
mesh term: Fibrosis
sharing ipd: No