<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/NCT03297229</url>
  </required_header>
  <id_info>
    <org_study_id>AR-T1087-P0001</org_study_id>
    <nct_id>NCT03297229</nct_id>
  </id_info>
  <brief_title>Effect of Peer Mentoring and Blood Pressure Self-monitoring on Hypertension Control.</brief_title>
  <official_title>Effectiveness of Peer Mentoring and Blood Pressure Self-monitoring for Blood Pressure Control in Vulnerable Population in Argentina. A Randomized Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute for Clinical Effectiveness and Health Policy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Inter-American Development Bank</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institute for Clinical Effectiveness and Health Policy</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>
      Cardiovascular diseases are increasing throughout the developing world and are the cause of&#xD;
      almost 16.7 million deaths each year, of which 80% occur in low and middle-income countries.&#xD;
      As more than three fourth of the global burden of cardiometabolic diseases are related to&#xD;
      risk factors connected with lifestyles or behaviors, such as smoking, unhealthy eating, low&#xD;
      physical activity, and harmful consumption of alcohol. This burden could be dramatically&#xD;
      reduced by changing individual behaviors. This study is focused on interventions that are&#xD;
      aimed to improve the adherence to treatment in cardiovascular disease (hypertension), based&#xD;
      on a Behavioral Economics approach. Most of public policies targeted to tackle&#xD;
      Noncommunicable diseases utilize a rational economic model of behavior.&#xD;
&#xD;
      Behavioral economics, by using insights from cognitive psychology and other social sciences,&#xD;
      has drawn a lot of attention for its potential to increase healthy behaviors. Interventions&#xD;
      informed by Behavioral economics principles seek to rearrange the social or physical&#xD;
      environment in such a way to 'nudge' people towards healthier choices and behaviors. This is&#xD;
      an individual controlled randomized trial which will be conducted to assess whether the&#xD;
      implementation of two strategies, blood pressure self-monitoring plus signing a &quot;contract of&#xD;
      commitment&quot;, and peer mentoring are effective to reduce blood pressure values over a period&#xD;
      of 3 months, compared to usual care. This randomized trial will enroll 430 patients from 10&#xD;
      public primary care clinics in Argentina.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 4, 2017</start_date>
  <completion_date type="Actual">March 1, 2018</completion_date>
  <primary_completion_date type="Actual">February 1, 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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>3 months</time_frame>
    <description>Net change in blood pressure levels from baseline to the end of follow-up in in each group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Controlled hypertension</measure>
    <time_frame>3 months</time_frame>
    <description>Proportion of patients with controlled hypertension (Systolic blood pressure &lt;140 mm Hg and diastolic blood pressure &lt;90 mm Hg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to antihypertensive medication</measure>
    <time_frame>3 months</time_frame>
    <description>Proportion of patients who had adhered to antihypertensive medication according to the Morisky Green Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensification of antihypertensive medication</measure>
    <time_frame>3 months</time_frame>
    <description>Proportion of patients who increased the number of antihypertensive medications or increase the dose of their antihypertensive medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visits to the clinic</measure>
    <time_frame>3 months</time_frame>
    <description>Number of visits to the clinic over the 3 month period of follow-up.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">442</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Peer mentoring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Peers will be patients with hypertension that have already been adequately controlled within the last six months. They will be selected within each center by the staff of the center and invited to participate in the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Self-monitoring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each participant will receive a blood pressure monitor. The study nurse will teach the participant on how to use the device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</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>Peer mentoring</intervention_name>
    <description>Peers will be assigned to participants according to common socio-demographic characteristics. Each peer will be assigned up to 5 participants.</description>
    <arm_group_label>Peer mentoring</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-monitoring</intervention_name>
    <description>Along with providing patients with a BP monitor, a &quot;commitment contract&quot; will be signed, in which participants commit themselves to measure their blood pressure at home at least once a week during the 3 months of the intervention. Each participant will be given a form to weekly recording their blood pressure values.</description>
    <arm_group_label>Self-monitoring</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults (21 years and older) who only have public health coverage, and have high blood&#xD;
             pressure (SBP ≥140 mmHg and / or DBP ≥90 mmHg)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women, bed-bound, and patients who cannot give informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vilma Irazola, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute for Clinical Effectiveness and Health Policy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro Asistencial Modelo Don Bosco</name>
      <address>
        <city>Quilmes</city>
        <state>Buenos Aires.</state>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlínico Julio Méndez</name>
      <address>
        <city>Quilmes</city>
        <state>Buenos Aires.</state>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UAP Illia</name>
      <address>
        <city>Vicente López</city>
        <state>Buenos Aires</state>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UAP Sargento Cabral</name>
      <address>
        <city>Vicente López</city>
        <state>Buenos Aires</state>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAPS 1 Simeon Payba</name>
      <address>
        <city>Paso de los Libres</city>
        <state>Corrientes</state>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAPS 10 Plurianual</name>
      <address>
        <city>Paso de los Libres</city>
        <state>Corrientes</state>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Atención Primaria de la Salud Dr. Balbastro</name>
      <address>
        <city>Corrientes</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Atención Primaria de la Salud N°15 Illia</name>
      <address>
        <city>Corrientes</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Salud nº 60 - El Mirador</name>
      <address>
        <city>Salta</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Salud Santa Ana</name>
      <address>
        <city>Salta</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>March 6, 2023</last_update_submitted>
  <last_update_submitted_qc>March 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Peer mentoring</keyword>
  <keyword>Self-monitoring</keyword>
  <keyword>Behavioral economics</keyword>
  <keyword>Hypertension</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</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/NCT03297229
org study id: AR-T1087-P0001
nct id: NCT03297229
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cardiovascular diseases are increasing throughout the developing world and are the cause of
      almost 16.7 million deaths each year, of which 80% occur in low and middle-income countries.
      As more than three fourth of the global burden of cardiometabolic diseases are related to
      risk factors connected with lifestyles or behaviors, such as smoking, unhealthy eating, low
      physical activity, and harmful consumption of alcohol. This burden could be dramatically
      reduced by changing individual behaviors. This study is focused on interventions that are
      aimed to improve the adherence to treatment in cardiovascular disease (hypertension), based
      on a Behavioral Economics approach. Most of public policies targeted to tackle
      Noncommunicable diseases utilize a rational economic model of behavior.

      Behavioral economics, by using insights from cognitive psychology and other social sciences,
      has drawn a lot of attention for its potential to increase healthy behaviors. Interventions
      informed by Behavioral economics principles seek to rearrange the social or physical
      environment in such a way to 'nudge' people towards healthier choices and behaviors. This is
      an individual controlled randomized trial which will be conducted to assess whether the
      implementation of two strategies, blood pressure self-monitoring plus signing a "contract of
      commitment", and peer mentoring are effective to reduce blood pressure values over a period
      of 3 months, compared to usual care. This randomized trial will enroll 430 patients from 10
      public primary care clinics in Argentina.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Blood pressure
time frame: 3 months
description: Net change in blood pressure levels from baseline to the end of follow-up in in each group.
measure: Controlled hypertension
time frame: 3 months
description: Proportion of patients with controlled hypertension (Systolic blood pressure <140 mm Hg and diastolic blood pressure <90 mm Hg)
measure: Adherence to antihypertensive medication
time frame: 3 months
description: Proportion of patients who had adhered to antihypertensive medication according to the Morisky Green Scale.
measure: Intensification of antihypertensive medication
time frame: 3 months
description: Proportion of patients who increased the number of antihypertensive medications or increase the dose of their antihypertensive medication.
measure: Visits to the clinic
time frame: 3 months
description: Number of visits to the clinic over the 3 month period of follow-up.
arm group label: Peer mentoring
arm group type: Experimental
description: Peers will be patients with hypertension that have already been adequately controlled within the last six months. They will be selected within each center by the staff of the center and invited to participate in the study.
arm group label: Self-monitoring
arm group type: Experimental
description: Each participant will receive a blood pressure monitor. The study nurse will teach the participant on how to use the device.
arm group label: Control
arm group type: No Intervention
description: Usual care
intervention type: Behavioral
intervention name: Peer mentoring
description: Peers will be assigned to participants according to common socio-demographic characteristics. Each peer will be assigned up to 5 participants.
arm group label: Peer mentoring
intervention type: Behavioral
intervention name: Self-monitoring
description: Along with providing patients with a BP monitor, a "commitment contract" will be signed, in which participants commit themselves to measure their blood pressure at home at least once a week during the 3 months of the intervention. Each participant will be given a form to weekly recording their blood pressure values.
arm group label: Self-monitoring
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Vilma Irazola, MD, PhD
role: Principal Investigator
affiliation: Institute for Clinical Effectiveness and Health Policy
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Argentina
responsible party type: Sponsor
mesh term: Hypertension