<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/NCT02258646</url>
  </required_header>
  <id_info>
    <org_study_id>228919/DHE</org_study_id>
    <secondary_id>HST1117-13</secondary_id>
    <secondary_id>HST1118-13</secondary_id>
    <nct_id>NCT02258646</nct_id>
  </id_info>
  <brief_title>Long-Term Integrated Telerehabilitation of COPD Patients. A Multi-Center Trial</brief_title>
  <acronym>iTrain</acronym>
  <official_title>Long-Term Integrated Telerehabilitation of COPD Patients. A Multi-Center Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital of North Norway</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Research Council of Norway</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Royal Norwegian Ministry of Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>LHL Helse</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Tromso</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>La Trobe University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Alfred</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aalborg University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital of South West Jutland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Esbjerg Municipality</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital of North Norway</source>
  <brief_summary>
    <textblock>
      This research project aims to conduct a three-arm multi-center randomized controlled trial&#xD;
      (RCT) on an innovative telerehabilitation intervention for patients with chronic obstructive&#xD;
      pulmonary disease (COPD). The overall purpose of the RCT is to demonstrate whether long-term&#xD;
      integrated telerehabilitation involving exercise training at home, telemonitoring, and&#xD;
      education/self-management will prevent hospital readmissions, thus reducing healthcare costs,&#xD;
      for patients with COPD, and will improve patient status and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 2018</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>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Combined number of hospitalizations and emergency department presentations</measure>
    <time_frame>Two years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospitalizations</measure>
    <time_frame>Two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emergency department presentations</measure>
    <time_frame>Two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>Two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time free from first hospitalization or emergency department presentation</measure>
    <time_frame>Two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>Two years</time_frame>
    <description>Cost-Utility Analysis (Cost/QALY)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in COPD Assessment Test at 6 months</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in COPD Assessment Test at 1 year</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in COPD Assessment Test at 2 years</measure>
    <time_frame>Two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in EQ-5D at 6 months</measure>
    <time_frame>Six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in EQ-5D at 1 year</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in EQ-5D at 2 years</measure>
    <time_frame>Two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Hospital Anxiety and Depression Scale at 6 months</measure>
    <time_frame>Six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Hospital Anxiety and Depression Scale at 1 year</measure>
    <time_frame>One Year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Hospital Anxiety and Depression Scale at 2 years</measure>
    <time_frame>Two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Generalized Self-Efficacy Scale at 6 months</measure>
    <time_frame>Six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Generalized Self-Efficacy Scale at 1 year</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Generalized Self-Efficacy Scale at 2 years</measure>
    <time_frame>Two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in 6- minute walking distance at 6 months</measure>
    <time_frame>Six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in 6- minute walking distance at 1 year</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in 6- minute walking distance at 2 years</measure>
    <time_frame>Two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in physical activity at 6 months</measure>
    <time_frame>Six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in physical activity at 1 year</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in physical activity at 2 years</measure>
    <time_frame>Two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Change after 2 years</measure>
    <time_frame>Two years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalizations at 1 year</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emergency department presentations at 1 year</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality at 1 year</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from baseline in BODE Index at 6 months</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in BODE Index at 1 year</measure>
    <time_frame>1 year</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in BODE Index at 2 years</measure>
    <time_frame>2 years</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>Telerehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise training at home, telemonitoring, and education/self-management</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Unsupervised exercise training at home</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Unsupervised exercise training at home</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise training at home</intervention_name>
    <arm_group_label>Telerehabilitation</arm_group_label>
    <arm_group_label>Unsupervised exercise training at home</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telemonitoring and education/self-management</intervention_name>
    <arm_group_label>Telerehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of COPD&#xD;
&#xD;
          -  At least one COPD-related hospitalization or COPD-related emergency department&#xD;
             presentation in the previous 12 months to enrollment&#xD;
&#xD;
          -  Capable to provide signed written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Attendance to a rehabilitation program in the previous 6 months of enrollment&#xD;
&#xD;
          -  Participation in another study that may have an impact on the outcome of this study&#xD;
&#xD;
          -  Deemed by the health care team to be physically uncapable to perform the study&#xD;
             procedures&#xD;
&#xD;
          -  Presence of comorbidities wich might prevent the patient from safely undertake an&#xD;
             exercise program at home&#xD;
&#xD;
          -  Home environment not suitable for installation and use of rehabilitation and&#xD;
             monitoring equipment (e.g. physical space, Wi-FI Internet or mobile Internet via 4G)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paolo Zanaboni, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of North Norway</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anne E Holland, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>La Trobe University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Birthe Dinesen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aalborg University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Alfred</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3181</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sydvestjysk Hospital</name>
      <address>
        <city>Esbjerg</city>
        <zip>6700</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of North Norway</name>
      <address>
        <city>Tromsø</city>
        <zip>9038</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Denmark</country>
    <country>Norway</country>
  </location_countries>
  <link>
    <url>https://ehealthresearch.no/en/projects/itrain-study</url>
    <description>Study website</description>
  </link>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>April 26, 2019</last_update_submitted>
  <last_update_submitted_qc>April 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exercise</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Telemedicine</keyword>
  <keyword>Treatment Outcome</keyword>
  <keyword>Costs and Cost Analysis</keyword>
  <keyword>Physical Therapists</keyword>
  <keyword>Adaptation, Psychological</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT02258646
org study id: 228919/DHE
secondary id: HST1117-13
secondary id: HST1118-13
nct id: NCT02258646
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
This research project aims to conduct a three-arm multi-center randomized controlled trial
      (RCT) on an innovative telerehabilitation intervention for patients with chronic obstructive
      pulmonary disease (COPD). The overall purpose of the RCT is to demonstrate whether long-term
      integrated telerehabilitation involving exercise training at home, telemonitoring, and
      education/self-management will prevent hospital readmissions, thus reducing healthcare costs,
      for patients with COPD, and will improve patient status and quality of life.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Combined number of hospitalizations and emergency department presentations
time frame: Two years
measure: Hospitalizations
time frame: Two years
measure: Emergency department presentations
time frame: Two years
measure: Mortality
time frame: Two years
measure: Time free from first hospitalization or emergency department presentation
time frame: Two years
measure: Cost-effectiveness
time frame: Two years
description: Cost-Utility Analysis (Cost/QALY)
measure: Change from baseline in COPD Assessment Test at 6 months
time frame: 6 months
measure: Change from baseline in COPD Assessment Test at 1 year
time frame: One year
measure: Change from baseline in COPD Assessment Test at 2 years
time frame: Two years
measure: Change from baseline in EQ-5D at 6 months
time frame: Six months
measure: Change from baseline in EQ-5D at 1 year
time frame: One year
measure: Change from baseline in EQ-5D at 2 years
time frame: Two years
measure: Change from baseline in Hospital Anxiety and Depression Scale at 6 months
time frame: Six months
measure: Change from baseline in Hospital Anxiety and Depression Scale at 1 year
time frame: One Year
measure: Change from baseline in Hospital Anxiety and Depression Scale at 2 years
time frame: Two years
measure: Change from baseline in Generalized Self-Efficacy Scale at 6 months
time frame: Six months
measure: Change from baseline in Generalized Self-Efficacy Scale at 1 year
time frame: One year
measure: Change from baseline in Generalized Self-Efficacy Scale at 2 years
time frame: Two years
measure: Change from baseline in 6- minute walking distance at 6 months
time frame: Six months
measure: Change from baseline in 6- minute walking distance at 1 year
time frame: One year
measure: Change from baseline in 6- minute walking distance at 2 years
time frame: Two years
measure: Change from baseline in physical activity at 6 months
time frame: Six months
measure: Change from baseline in physical activity at 1 year
time frame: One year
measure: Change from baseline in physical activity at 2 years
time frame: Two years
measure: Patient Global Impression of Change after 2 years
time frame: Two years
measure: Hospitalizations at 1 year
time frame: One year
measure: Emergency department presentations at 1 year
time frame: One year
measure: Mortality at 1 year
time frame: One year
measure: Change from baseline in BODE Index at 6 months
time frame: 6 months
measure: Change from baseline in BODE Index at 1 year
time frame: 1 year
measure: Change from baseline in BODE Index at 2 years
time frame: 2 years
arm group label: Telerehabilitation
arm group type: Experimental
description: Exercise training at home, telemonitoring, and education/self-management
arm group label: Unsupervised exercise training at home
arm group type: Experimental
description: Unsupervised exercise training at home
arm group label: Usual care
arm group type: No Intervention
description: Usual care
intervention type: Behavioral
intervention name: Exercise training at home
arm group label: Telerehabilitation
arm group label: Unsupervised exercise training at home
intervention type: Behavioral
intervention name: Telemonitoring and education/self-management
arm group label: Telerehabilitation
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Paolo Zanaboni, PhD
role: Principal Investigator
affiliation: University Hospital of North Norway
last name: Anne E Holland, PhD
role: Principal Investigator
affiliation: La Trobe University
last name: Birthe Dinesen, PhD
role: Principal Investigator
affiliation: Aalborg University
facility: 
facility: 
facility: 
country: Australia
country: Denmark
country: Norway
url: https://ehealthresearch.no/en/projects/itrain-study
description: Study website
responsible party type: Sponsor
mesh term: Pulmonary Disease, Chronic Obstructive