<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/NCT03797768</url>
  </required_header>
  <id_info>
    <org_study_id>AUTBA18</org_study_id>
    <nct_id>NCT03797768</nct_id>
  </id_info>
  <brief_title>Community-based Management of Chronic Obstructive Pulmonary Disease in Nepal</brief_title>
  <acronym>COBIN-P</acronym>
  <official_title>Protocol for Community-based Management of Chronic Obstructive Pulmonary Disease in Nepal: a Community-based Cluster Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Chronic Obstructive Pulmonary Disease (COPD) is the fourth most important cause of death&#xD;
      worldwide and is one of the commonest non-communicable diseases (NCDs) in Nepal. The presence&#xD;
      of risk factors like indoor and outdoor air pollution, the high prevalence of smoking and&#xD;
      lack of general awareness of COPD makes it a serious public health concern. However, no&#xD;
      attempt has been made in Nepal to estimate its burden and address the disease at the&#xD;
      community level. This community-based cluster randomized controlled study aims to fulfil that&#xD;
      gap through mobilization of Female Community Health Workers (FCHVs) who will be trained to&#xD;
      perform a certain set of health promotion activities aimed at prevention of the disease and&#xD;
      its progression. Baseline and follow-up surveys will be conducted to compare the intervention&#xD;
      and control groups. This study has the potential to generate evidence in helping address NCDs&#xD;
      in Nepal and also other similar resource-limited countries.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">December 25, 2019</start_date>
  <completion_date type="Anticipated">September 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 10, 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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Forced Expiratory Volume in 1 second</measure>
    <time_frame>1 year</time_frame>
    <description>Mean difference in FVE1 between intervention and control arm</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of risk factors of COPD between intervention and control arm</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1438</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioural-FCHV Visit</intervention_name>
    <description>Female Community Health Volunteer will visit selected households on average 3 times a year for providing health promotion messages on improving lung health status and avoiding risk factors to COPD.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Capable of performing spirometry&#xD;
&#xD;
          -  Aged greater than and equal to 40 years&#xD;
&#xD;
          -  Full time residents in the study area and will be in the study area for at least one&#xD;
             year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than 40 years of age&#xD;
&#xD;
          -  Self-reported pregnancy&#xD;
&#xD;
          -  having active pulmonary tuberculosis or being on medications for pulmonary&#xD;
             tuberculosis&#xD;
&#xD;
          -  thoracic, abdominal or eye surgery in the last six months&#xD;
&#xD;
          -  History of Mental illness&#xD;
&#xD;
          -  MI in past 8 weeks prior to study&#xD;
&#xD;
          -  Hospital admission in the past six months for cardiac illness&#xD;
&#xD;
          -  Those who decline to provide consent to the study will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tara Ballav Adhikari, MScPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Public Health, Aarhus University, Aarhus, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aarhus University</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <link>
    <url>https://doi.org/10.2147/COPD.S268110</url>
    <description>Prevalence of Chronic Obstructive Pulmonary Disease and its Associated Factors in Nepal: Findings from a Community-based Household Survey</description>
  </link>
  <reference>
    <citation>Adhikari TB, Acharya P, Hogman M, Neupane D, Karki A, Drews A, Cooper BG, Sigsgaard T, Kallestrup P. Prevalence of Chronic Obstructive Pulmonary Disease and its Associated Factors in Nepal: Findings from a Community-based Household Survey. Int J Chron Obstruct Pulmon Dis. 2020 Sep 29;15:2319-2331. doi: 10.2147/COPD.S268110. eCollection 2020.</citation>
    <PMID>33061350</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>January 25, 2021</last_update_submitted>
  <last_update_submitted_qc>January 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2021</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>
  <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/NCT03797768
org study id: AUTBA18
nct id: NCT03797768
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Chronic Obstructive Pulmonary Disease (COPD) is the fourth most important cause of death
      worldwide and is one of the commonest non-communicable diseases (NCDs) in Nepal. The presence
      of risk factors like indoor and outdoor air pollution, the high prevalence of smoking and
      lack of general awareness of COPD makes it a serious public health concern. However, no
      attempt has been made in Nepal to estimate its burden and address the disease at the
      community level. This community-based cluster randomized controlled study aims to fulfil that
      gap through mobilization of Female Community Health Workers (FCHVs) who will be trained to
      perform a certain set of health promotion activities aimed at prevention of the disease and
      its progression. Baseline and follow-up surveys will be conducted to compare the intervention
      and control groups. This study has the potential to generate evidence in helping address NCDs
      in Nepal and also other similar resource-limited countries.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Forced Expiratory Volume in 1 second
time frame: 1 year
description: Mean difference in FVE1 between intervention and control arm
measure: Proportion of risk factors of COPD between intervention and control arm
time frame: 1 year
arm group label: Intervention
arm group type: Experimental
arm group label: Control
arm group type: No Intervention
intervention type: Behavioral
intervention name: Behavioural-FCHV Visit
description: Female Community Health Volunteer will visit selected households on average 3 times a year for providing health promotion messages on improving lung health status and avoiding risk factors to COPD.
arm group label: Intervention
criteria: 
gender: All
minimum age: 40 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tara Ballav Adhikari, MScPH
role: Principal Investigator
affiliation: Department of Public Health, Aarhus University, Aarhus, Denmark
facility: 
country: Denmark
url: https://doi.org/10.2147/COPD.S268110
description: Prevalence of Chronic Obstructive Pulmonary Disease and its Associated Factors in Nepal: Findings from a Community-based Household Survey
citation: Adhikari TB, Acharya P, Hogman M, Neupane D, Karki A, Drews A, Cooper BG, Sigsgaard T, Kallestrup P. Prevalence of Chronic Obstructive Pulmonary Disease and its Associated Factors in Nepal: Findings from a Community-based Household Survey. Int J Chron Obstruct Pulmon Dis. 2020 Sep 29;15:2319-2331. doi: 10.2147/COPD.S268110. eCollection 2020.
PMID: 33061350
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No