<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/NCT01724684</url>
  </required_header>
  <id_info>
    <org_study_id>201106097RB</org_study_id>
    <nct_id>NCT01724684</nct_id>
  </id_info>
  <brief_title>Feasibility and Effectiveness of Telehealth in Patients With Chronic Obstructive Pulmonary Disease in Taiwan</brief_title>
  <official_title>Feasibility and Effectiveness of Telehealth in Patients With Chronic Obstructive Pulmonary Disease in Taiwan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recent studies have demonstrated the promising potential that telehealth has in management of&#xD;
      chronic disease. For COPD patients, implementation of telehealth reduced readmissions,&#xD;
      emergency room visits, and exacerbations and was cost-effective. Telehealth as a method of&#xD;
      delivering healthcare to remote, resource-deprived areas is not lacking in evidence of&#xD;
      benefit; however, the situation about its more widespread use for monitoring purposes is much&#xD;
      less clear. To date, most of the studies dealing with telehealth in COPD were conducted in&#xD;
      countries covering vast territories. Therefore, it needs to be investigated whether&#xD;
      telehealth conveys similar advantages for COPD patients in a small island country.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2011</start_date>
  <primary_completion_date type="Anticipated">December 2012</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with Hospital Readmission at 6 months</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Telehealth program</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Telehealth program service</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Usual care service</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Telehealth program</intervention_name>
    <arm_group_label>Telehealth program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admissions for chronic obstructive pulmonary disease&#xD;
&#xD;
          -  Age 20 or more&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Discharge against medical advice&#xD;
&#xD;
          -  Enrolled in other trials&#xD;
&#xD;
          -  Not being discharged to home&#xD;
&#xD;
          -  Unconsciousness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chun-Ta Huang, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chun-Ta Huang, MD</last_name>
    <email>huangct@ntu.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chun-Ta Huang, MD</last_name>
      <email>huangct@ntu.edu.tw</email>
    </contact>
    <investigator>
      <last_name>Chun-Ta Huang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>January 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>November 7, 2012</last_update_submitted>
  <last_update_submitted_qc>November 7, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 12, 2012</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>Lung Diseases</mesh_term>
    <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/NCT01724684
org study id: 201106097RB
nct id: NCT01724684
lead sponsor: 
has dmc: No
Recent studies have demonstrated the promising potential that telehealth has in management of
      chronic disease. For COPD patients, implementation of telehealth reduced readmissions,
      emergency room visits, and exacerbations and was cost-effective. Telehealth as a method of
      delivering healthcare to remote, resource-deprived areas is not lacking in evidence of
      benefit; however, the situation about its more widespread use for monitoring purposes is much
      less clear. To date, most of the studies dealing with telehealth in COPD were conducted in
      countries covering vast territories. Therefore, it needs to be investigated whether
      telehealth conveys similar advantages for COPD patients in a small island country.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Number of Participants with Hospital Readmission at 6 months
time frame: 6 months
arm group label: Telehealth program
arm group type: Other
description: Telehealth program service
arm group label: Usual care
arm group type: Other
description: Usual care service
intervention type: Other
intervention name: Telehealth program
arm group label: Telehealth program
intervention type: Other
intervention name: Usual care
arm group label: Usual care
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Chun-Ta Huang, M.D
role: Principal Investigator
affiliation: National Taiwan University Hospital
last name: Chun-Ta Huang, MD
email: huangct@ntu.edu.tw
facility: 
status: Recruiting
contact: 
investigator: 
country: Taiwan
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive