<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/NCT03304158</url>
  </required_header>
  <id_info>
    <org_study_id>AUBIS123</org_study_id>
    <nct_id>NCT03304158</nct_id>
  </id_info>
  <brief_title>Community Based Management of Diabetes in Nepal</brief_title>
  <acronym>COBIN-D</acronym>
  <official_title>Community Based Intervention for Management of Diabetes in Nepal (COBIN-D): A Cluster Randomised 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>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>
      Type 2 diabetes is the largest growing concern across the globe, and this is particularly&#xD;
      apparent in developing countries, including Nepal. Despite the growing burden and chronic&#xD;
      nature of diabetes, prevention and control of this disease is far from adequate setting in&#xD;
      Nepal. Moreover, there is lack of evidence on effectiveness and affordability of a population&#xD;
      approach on reducing blood glucose level among diabetes persons. The main aim of this study&#xD;
      is to determine the effect of Female Community Health Volunteers' (FCHVs)-led family-based&#xD;
      health education and screening on blood sugar level in adults at community level in Nepal.&#xD;
      This is a community-based cluster randomized controlled trial involving family based health&#xD;
      education through FCHVs in Nepal. People ≥25 years of age listed in the Community-Based&#xD;
      Management of Hypertension (COBIN) study and who were diabetics are eligible for eligible for&#xD;
      participation in the study. FCHVs will conduct family based health education and fasting&#xD;
      blood glucose measurements in the treatment arm vs not any interventions in the control arm.&#xD;
      Independent assessors will conduct the baseline and end line assessment of the intervention.&#xD;
      Intention to treat analysis and per protocol analysis will be used in analysis to detect&#xD;
      significant differences between treatment and control group participants at baseline and&#xD;
      follow up. For individual outcomes, proportions will be compared using Chi-square test and&#xD;
      continuous measures will be compared using t-tests. Random effect mixed regression analysis&#xD;
      will be adjusted for age and sex. Since randomisation will be at the cluster level in the&#xD;
      study, a random-effect model will be used to account for clustering effect. Effectiveness of&#xD;
      the intervention will be tested by analysis of covariance, which will allow us to adjust for&#xD;
      baseline differences between groups. It is anticipated that the study can give valuable&#xD;
      information regarding effectiveness, acceptability, and feasibility of an innovative way to&#xD;
      improve diabetes management. Assessing the FCHVs' ability to address diabetes may contribute&#xD;
      to develop a policy that can be scaled-up to a national level.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">January 31, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean fasting blood glucose level</measure>
    <time_frame>1 year</time_frame>
    <description>Change in mean fasting blood glucose level in diabetes populations</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">224</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>FCHV visit-diabetes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>FCHV no visit-diabetes</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>FCHV visit</intervention_name>
    <description>FCHVs will visit selected households 3 times a year for providing health promotion messages and measure the blood glucose</description>
    <arm_group_label>FCHV visit-diabetes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Those ≥25 years of age and listed in the COBIN study&#xD;
&#xD;
          -  Those who participated in our prevalence study&#xD;
&#xD;
          -  Those who give consent to participate in our intervention study&#xD;
&#xD;
          -  Those who do not have any plan to migrate from the study area for at least 1 year&#xD;
&#xD;
          -  Those who are non-pregnant women&#xD;
&#xD;
          -  Those who are not severely ill&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those who do not give consent&#xD;
&#xD;
          -  Those who are pregnant women&#xD;
&#xD;
          -  Those who are severely ill&#xD;
&#xD;
          -  Those who have plans to migrate from the study area within 1 year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>A semi-urban area of Pokhara-Lekhnath Metropolitan City of Nepal</name>
      <address>
        <city>Pokhara</city>
        <country>Nepal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Nepal</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>October 3, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>August 12, 2020</last_update_submitted>
  <last_update_submitted_qc>August 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Aarhus</investigator_affiliation>
    <investigator_full_name>Bishal Gyawali</investigator_full_name>
    <investigator_title>PhD scholar</investigator_title>
  </responsible_party>
  <keyword>Diabetes</keyword>
  <keyword>Non-communicable disease</keyword>
  <keyword>Primary health care</keyword>
  <keyword>Nepal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT03304158
org study id: AUBIS123
nct id: NCT03304158
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Type 2 diabetes is the largest growing concern across the globe, and this is particularly
      apparent in developing countries, including Nepal. Despite the growing burden and chronic
      nature of diabetes, prevention and control of this disease is far from adequate setting in
      Nepal. Moreover, there is lack of evidence on effectiveness and affordability of a population
      approach on reducing blood glucose level among diabetes persons. The main aim of this study
      is to determine the effect of Female Community Health Volunteers' (FCHVs)-led family-based
      health education and screening on blood sugar level in adults at community level in Nepal.
      This is a community-based cluster randomized controlled trial involving family based health
      education through FCHVs in Nepal. People ≥25 years of age listed in the Community-Based
      Management of Hypertension (COBIN) study and who were diabetics are eligible for eligible for
      participation in the study. FCHVs will conduct family based health education and fasting
      blood glucose measurements in the treatment arm vs not any interventions in the control arm.
      Independent assessors will conduct the baseline and end line assessment of the intervention.
      Intention to treat analysis and per protocol analysis will be used in analysis to detect
      significant differences between treatment and control group participants at baseline and
      follow up. For individual outcomes, proportions will be compared using Chi-square test and
      continuous measures will be compared using t-tests. Random effect mixed regression analysis
      will be adjusted for age and sex. Since randomisation will be at the cluster level in the
      study, a random-effect model will be used to account for clustering effect. Effectiveness of
      the intervention will be tested by analysis of covariance, which will allow us to adjust for
      baseline differences between groups. It is anticipated that the study can give valuable
      information regarding effectiveness, acceptability, and feasibility of an innovative way to
      improve diabetes management. Assessing the FCHVs' ability to address diabetes may contribute
      to develop a policy that can be scaled-up to a national level.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Mean fasting blood glucose level
time frame: 1 year
description: Change in mean fasting blood glucose level in diabetes populations
arm group label: FCHV visit-diabetes
arm group type: Experimental
arm group label: FCHV no visit-diabetes
arm group type: No Intervention
intervention type: Behavioral
intervention name: FCHV visit
description: FCHVs will visit selected households 3 times a year for providing health promotion messages and measure the blood glucose
arm group label: FCHV visit-diabetes
criteria: 
gender: All
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Nepal
responsible party type: Principal Investigator
investigator affiliation: University of Aarhus
investigator full name: Bishal Gyawali
investigator title: PhD scholar
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No