<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/NCT04416295</url>
  </required_header>
  <id_info>
    <org_study_id>SMART-COPD</org_study_id>
    <nct_id>NCT04416295</nct_id>
  </id_info>
  <brief_title>Selfcare MAnagement InteRvenTion in COPD (SMART COPD)</brief_title>
  <official_title>Evaluation of a Digital Support and Communication Platform for COPD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lund University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lund University</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>
      To evaluate whether a digital support and communication platform for COPD patients after 6&#xD;
      months provides:&#xD;
&#xD;
        1. Decreased breathlessness on the basis of modified medical research council dyspnea scale&#xD;
           [mMRC]&#xD;
&#xD;
        2. Improved health status and symptom relief based on COPD assessment scale [CAT]&#xD;
&#xD;
        3. Improved quality of life based on EQ-5D&#xD;
&#xD;
        4. Reduction in the number of incidents, hospital nights, the number of hospitalizations,&#xD;
           outpatient contacts or the number of deaths related to COPD&#xD;
&#xD;
        5. A change in the classification of COPD severity based on GOLD A-D&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2019</start_date>
  <completion_date type="Actual">April 30, 2021</completion_date>
  <primary_completion_date type="Actual">January 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>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Severity of dyspnea on the basis of modified medical research council dyspnea scale [mMRC]</measure>
    <time_frame>6 months</time_frame>
    <description>Dyspnea is measured with mMRC from 0-4 where high figure represent dyspnea in minimal exertion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in health status and symptom relief based on COPD assessment scale [CAT]</measure>
    <time_frame>6 months</time_frame>
    <description>Health status and symptom is evaluated with COPD assessment scale (CAT) where the scale is from 0-40 and where high score represent worse health status and symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>6 months</time_frame>
    <description>Improved quality of life as measured on visual analogue scale 0-100 where high figure represent best quality of life</description>
  </primary_outcome>
  <primary_outcome>
    <measure>A change in the classification of COPD severity based on GOLD A-D</measure>
    <time_frame>6 months</time_frame>
    <description>A change in the classification of COPD severity based on GOLD 1-4 (A-D) where high figure represent worse severity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in patient reported symptoms</measure>
    <time_frame>6 months</time_frame>
    <description>Improved patient-reported symptoms as measured by questionnaire EuroQol three-dimensional questionnaire (EQ-5D-3L ) where high score represent worse symptoms. The minimum score is 7 points and the maximum score is 23 points.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with COPD related events and deaths during intervention and up to 12 months after inclusion</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with new hospitalization up 12 months after inclusion</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of hospital days during intervention and up 12 months after inclusion</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of health care visits during intervention and up to 12 months after inclusion</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Copd</condition>
  <condition>Assessment, Self</condition>
  <condition>Hospitalization</condition>
  <arm_group>
    <arm_group_label>Standard COPD care and a digital COPD support system</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Device: LifePod The intervention group is testing LifePod on a digital communication platform between patient and healthcare provide</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group Standard COPD Care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LifePod</intervention_name>
    <description>LifePod consists of a Web-based E-Health platform with two interfaces, one medical for healthcare professionals and one patient interface. LifePod is accessed via a smartphone, tablets and computers via a web application where patients enter symptom parameters and vital parameters such as breathing and mucus status, weight, activity, medication or other disease-specific values. Several different validated questionnaires are sent regularly to the patient to obtain information about the patient's mood and activity. The platform contains a chat function between healthcare professionals and patients. A unique health profile is created in which the patient self-reports their health. The patient receives direct feedback in their web application if they are within the interval given for the individual. The medical interfaces are designed so that patients are automatically placed in a priority order where the person outside the given range is given top priority.</description>
    <arm_group_label>Control group Standard COPD Care</arm_group_label>
    <arm_group_label>Standard COPD care and a digital COPD support system</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The patient is included in the study in connection with visits to COPD.&#xD;
&#xD;
          -  Diagnosed COPD J44 (newly discovered or existing)&#xD;
&#xD;
          -  Have completed the consent form&#xD;
&#xD;
          -  Is judged to be able to handle the intervention himself or with the help of staff or&#xD;
             relatives&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patient who declines to participate in the trial.&#xD;
&#xD;
          -  Impaired cognitive ability that is judged to affect the ability to conduct the study&#xD;
             in the intended manner.&#xD;
&#xD;
          -  Life expectancy &lt;8 months&#xD;
&#xD;
          -  In other ways, treating physicians are deemed to be inappropriate to participate in&#xD;
             the study, e.g. due to participation in another study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Lund University</name>
      <address>
        <city>Lund</city>
        <state>Skåne</state>
        <zip>22100</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 28, 2021</last_update_submitted>
  <last_update_submitted_qc>June 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lund University</investigator_affiliation>
    <investigator_full_name>Sofia Gerward</investigator_full_name>
    <investigator_title>Principal Investigator, MD, PhD</investigator_title>
  </responsible_party>
  <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/NCT04416295
org study id: SMART-COPD
nct id: NCT04416295
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate whether a digital support and communication platform for COPD patients after 6
      months provides:

        1. Decreased breathlessness on the basis of modified medical research council dyspnea scale
           [mMRC]

        2. Improved health status and symptom relief based on COPD assessment scale [CAT]

        3. Improved quality of life based on EQ-5D

        4. Reduction in the number of incidents, hospital nights, the number of hospitalizations,
           outpatient contacts or the number of deaths related to COPD

        5. A change in the classification of COPD severity based on GOLD A-D
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: Double (Care Provider, Investigator)
measure: Severity of dyspnea on the basis of modified medical research council dyspnea scale [mMRC]
time frame: 6 months
description: Dyspnea is measured with mMRC from 0-4 where high figure represent dyspnea in minimal exertion
measure: Change in health status and symptom relief based on COPD assessment scale [CAT]
time frame: 6 months
description: Health status and symptom is evaluated with COPD assessment scale (CAT) where the scale is from 0-40 and where high score represent worse health status and symptoms
measure: Change in quality of life
time frame: 6 months
description: Improved quality of life as measured on visual analogue scale 0-100 where high figure represent best quality of life
measure: A change in the classification of COPD severity based on GOLD A-D
time frame: 6 months
description: A change in the classification of COPD severity based on GOLD 1-4 (A-D) where high figure represent worse severity
measure: Change in patient reported symptoms
time frame: 6 months
description: Improved patient-reported symptoms as measured by questionnaire EuroQol three-dimensional questionnaire (EQ-5D-3L ) where high score represent worse symptoms. The minimum score is 7 points and the maximum score is 23 points.
measure: Number of participants with COPD related events and deaths during intervention and up to 12 months after inclusion
time frame: 12 months
measure: Number of participants with new hospitalization up 12 months after inclusion
time frame: 12 months
measure: Number of hospital days during intervention and up 12 months after inclusion
time frame: 12 months
measure: Number of health care visits during intervention and up to 12 months after inclusion
time frame: 12 months
arm group label: Standard COPD care and a digital COPD support system
arm group type: Active Comparator
description: Device: LifePod The intervention group is testing LifePod on a digital communication platform between patient and healthcare provide
arm group label: Control group Standard COPD Care
arm group type: Other
intervention type: Device
intervention name: LifePod
description: LifePod consists of a Web-based E-Health platform with two interfaces, one medical for healthcare professionals and one patient interface. LifePod is accessed via a smartphone, tablets and computers via a web application where patients enter symptom parameters and vital parameters such as breathing and mucus status, weight, activity, medication or other disease-specific values. Several different validated questionnaires are sent regularly to the patient to obtain information about the patient's mood and activity. The platform contains a chat function between healthcare professionals and patients. A unique health profile is created in which the patient self-reports their health. The patient receives direct feedback in their web application if they are within the interval given for the individual. The medical interfaces are designed so that patients are automatically placed in a priority order where the person outside the given range is given top priority.
arm group label: Control group Standard COPD Care
arm group label: Standard COPD care and a digital COPD support system
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Lund University
investigator full name: Sofia Gerward
investigator title: Principal Investigator, MD, PhD
sharing ipd: No