<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/NCT02981251</url>
  </required_header>
  <id_info>
    <org_study_id>24/2016</org_study_id>
    <nct_id>NCT02981251</nct_id>
  </id_info>
  <brief_title>Community Based Health Education to Manage Uncontrolled Blood Pressure in Surkhet, Nepal</brief_title>
  <official_title>Effectiveness of Community Based Health Education in Reduction of Blood Pressure Among Uncontrolled Hypertensive Patients of Suburban Population of Surkhet District of Nepal</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bheri Zonal Ayurveda Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bheri Zonal Ayurveda Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate the effect of health education on blood pressure&#xD;
      reduction compared to usual care among uncontrolled hypertensive patients of suburban&#xD;
      community of Surkhet district of Nepal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Maintenance of normal blood pressure range is necessary to prevent early occurrence of&#xD;
      cardiovascular diseases and kidney disease. Adherence of healthy behavior and lifestyle along&#xD;
      with medication (if prescribed) are mandatory for effective management of hypertension.&#xD;
      Although knowledge and motivation is required for such adherence through health education to&#xD;
      the patients,however, no studies has been conducted in Nepal in community setting. Thus, our&#xD;
      study will evaluate the effect of health education on blood pressure reduction in community&#xD;
      settings.&#xD;
&#xD;
      Method: Cluster randomized trial will be conducted in Birendranagar Municipality of Surkhet&#xD;
      District of Nepal. Wards will be clusters where only four ward will be selected randomly&#xD;
      among 12 wards wards. Screening program will be conducted for uncontrolled hypertensive&#xD;
      patients by visiting every household in systematic manner. Total 36 eligible participants&#xD;
      will be enrolled from each cluster who meet the inclusive criteria and provide consent. Then,&#xD;
      two clusters will be assigned to for intervention by using simple randomization procedure.&#xD;
      Uncontrolled hypertensive patients from rest of two clusters will be the control group who&#xD;
      will get usual care by their physician. Four sessions of hypertension related health&#xD;
      education will be provided by medical officer and/or registered nurse to intervention group&#xD;
      within six months. Trained female health volunteer will visit the participant's home twice a&#xD;
      month and will record their blood pressure, motivate the patient and their family members to&#xD;
      adhere on healthy behavior and medicine. Follow up data collection will be done after six&#xD;
      months. Paired t- test (continues variable) and Chi-square test (binary variable) will be&#xD;
      used to test the significance for baseline and after six months for both intervention and&#xD;
      control group. Similarly, independent t test (continuous variable) and Chi-square test&#xD;
      (binary variable) will be used to test the difference between the groups. Multiple logistic&#xD;
      regression analysis will be conducted to evaluate the effect of intervention with and without&#xD;
      adjusting confounders.&#xD;
&#xD;
      Expected Results: Primary outcome of the study will be proportion of normalized systolic&#xD;
      blood pressure in both the groups. The study will determine the effect of intervention on the&#xD;
      between-group difference in the proportion of patients with normalized systolic blood&#xD;
      pressure.&#xD;
&#xD;
      Conclusion: The study will be useful to evaluate the effectiveness of health education in&#xD;
      community setting. Thus the study will be useful for planning and implementing health&#xD;
      education in community to control blood pressure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</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>Proportion of patients with normalized systolic blood pressure of less than 140 mm Hg</measure>
    <time_frame>six months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patient with normal diastolic blood pressure less than 90 mm Hg</measure>
    <time_frame>six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mean systolic and diastolic blood pressure</measure>
    <time_frame>six months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">142</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Health education with support by trained female health volunteer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Extra intervention will not be provided except usual care by their physician of the participant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health education with support by trained female health volunteer</intervention_name>
    <description>Along with usual care four sessions of interactive health education will be provided to the participants by medical officer and/or registered nurse based on a syllabus for six months. Trained female female health volunteer will motivate the participants through their home visit twice a month where they will monitor blood pressure and counsel the family members to support the patient.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Who is willing to participate and give consent for the study&#xD;
&#xD;
          -  Uncontrolled hypertension (SBP≥140 mmHg and/or DBP≥90mmHg) including those on&#xD;
             antihypertensive medication&#xD;
&#xD;
          -  Can understand Nepali language&#xD;
&#xD;
          -  Capable of effective oral communication&#xD;
&#xD;
          -  Who has telephone or mobile number -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dementia and other mental illness&#xD;
&#xD;
          -  Bed ridden patients&#xD;
&#xD;
          -  Known kidney disease, cancer, heart problem, chronic obstructive pulmonary disease&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Participant who is either blind or deaf&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mahesh Kumar Khanal, MPhil</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bheri Zonal Ayurveda Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Raja Ram Dhungana, MPhil</last_name>
    <role>Study Director</role>
    <affiliation>Nepal Public Health Foundation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yadav Gurung, MPH</last_name>
    <role>Study Chair</role>
    <affiliation>Nepal Family Development Foundation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pratiksha Bhandari, MA</last_name>
    <role>Study Chair</role>
    <affiliation>Mid Western Regional Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>K.N. Poudel, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Surkhet Hospital Pvt. Lmt.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bheri Zonal Ayurveda Hospital</name>
      <address>
        <city>Surkhet</city>
        <state>Birendranagar Municipality</state>
        <country>Nepal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Nepal</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>September 2, 2017</last_update_submitted>
  <last_update_submitted_qc>September 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bheri Zonal Ayurveda Hospital</investigator_affiliation>
    <investigator_full_name>Dr. Mahesh Kumar Khanal</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>Hypertension</keyword>
  <keyword>Uncontrolled blood pressure</keyword>
  <keyword>Health education</keyword>
  <keyword>Community based</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Not decided yet</ipd_description>
  </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/NCT02981251
org study id: 24/2016
nct id: NCT02981251
lead sponsor: 
has dmc: Yes
The purpose of the study is to evaluate the effect of health education on blood pressure
      reduction compared to usual care among uncontrolled hypertensive patients of suburban
      community of Surkhet district of Nepal.
Maintenance of normal blood pressure range is necessary to prevent early occurrence of
      cardiovascular diseases and kidney disease. Adherence of healthy behavior and lifestyle along
      with medication (if prescribed) are mandatory for effective management of hypertension.
      Although knowledge and motivation is required for such adherence through health education to
      the patients,however, no studies has been conducted in Nepal in community setting. Thus, our
      study will evaluate the effect of health education on blood pressure reduction in community
      settings.

      Method: Cluster randomized trial will be conducted in Birendranagar Municipality of Surkhet
      District of Nepal. Wards will be clusters where only four ward will be selected randomly
      among 12 wards wards. Screening program will be conducted for uncontrolled hypertensive
      patients by visiting every household in systematic manner. Total 36 eligible participants
      will be enrolled from each cluster who meet the inclusive criteria and provide consent. Then,
      two clusters will be assigned to for intervention by using simple randomization procedure.
      Uncontrolled hypertensive patients from rest of two clusters will be the control group who
      will get usual care by their physician. Four sessions of hypertension related health
      education will be provided by medical officer and/or registered nurse to intervention group
      within six months. Trained female health volunteer will visit the participant's home twice a
      month and will record their blood pressure, motivate the patient and their family members to
      adhere on healthy behavior and medicine. Follow up data collection will be done after six
      months. Paired t- test (continues variable) and Chi-square test (binary variable) will be
      used to test the significance for baseline and after six months for both intervention and
      control group. Similarly, independent t test (continuous variable) and Chi-square test
      (binary variable) will be used to test the difference between the groups. Multiple logistic
      regression analysis will be conducted to evaluate the effect of intervention with and without
      adjusting confounders.

      Expected Results: Primary outcome of the study will be proportion of normalized systolic
      blood pressure in both the groups. The study will determine the effect of intervention on the
      between-group difference in the proportion of patients with normalized systolic blood
      pressure.

      Conclusion: The study will be useful to evaluate the effectiveness of health education in
      community setting. Thus the study will be useful for planning and implementing health
      education in community to control blood pressure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Proportion of patients with normalized systolic blood pressure of less than 140 mm Hg
time frame: six months
measure: Proportion of patient with normal diastolic blood pressure less than 90 mm Hg
time frame: six months
measure: Change in mean systolic and diastolic blood pressure
time frame: six months
arm group label: Intervention
arm group type: Experimental
description: Health education with support by trained female health volunteer
arm group label: Control
arm group type: No Intervention
description: Extra intervention will not be provided except usual care by their physician of the participant.
intervention type: Behavioral
intervention name: Health education with support by trained female health volunteer
description: Along with usual care four sessions of interactive health education will be provided to the participants by medical officer and/or registered nurse based on a syllabus for six months. Trained female female health volunteer will motivate the participants through their home visit twice a month where they will monitor blood pressure and counsel the family members to support the patient.
arm group label: Intervention
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
last name: Mahesh Kumar Khanal, MPhil
role: Principal Investigator
affiliation: Bheri Zonal Ayurveda Hospital
last name: Raja Ram Dhungana, MPhil
role: Study Director
affiliation: Nepal Public Health Foundation
last name: Yadav Gurung, MPH
role: Study Chair
affiliation: Nepal Family Development Foundation
last name: Pratiksha Bhandari, MA
role: Study Chair
affiliation: Mid Western Regional Hospital
last name: K.N. Poudel, MD
role: Study Chair
affiliation: Surkhet Hospital Pvt. Lmt.
facility: 
country: Nepal
responsible party type: Principal Investigator
investigator affiliation: Bheri Zonal Ayurveda Hospital
investigator full name: Dr. Mahesh Kumar Khanal
investigator title: Director
mesh term: Hypertension
sharing ipd: Undecided
ipd description: Not decided yet