<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/NCT01696318</url>
  </required_header>
  <id_info>
    <org_study_id>U1111-1134-6977</org_study_id>
    <secondary_id>HMV - 680</secondary_id>
    <nct_id>NCT01696318</nct_id>
  </id_info>
  <brief_title>Program for Cardiovascular Prevention and Randomized Clinical Trial</brief_title>
  <official_title>Management Models for Cardiovascular Risk Reduction in Primary for Brazil: Developing a Program for Cardiovascular Prevention and Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Rio Grande do Sul</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Moinhos de Vento</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Federal University of Rio Grande do Sul</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Develop and evaluate a model of organization and management in the management of patients&#xD;
      with cardiovascular risk factors (hypertension, diabetes mellitus, smoking, obesity, physical&#xD;
      inactivity, dyslipidemia and family history) in primary care aimed at the compliance, control&#xD;
      and treatment effectiveness.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>Change from baseline in Systolic Blood Pressure at 6 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">256</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Educational program</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Educational Program with Professional Physical Education, Pharmacist and Nutritionist</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Educational program and individual care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Educational program and individual care with professional Physical Education; Pharmacist and Nutritionist</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Support for the Family Health Team</intervention_name>
    <description>Participation in physical educator, dietitian and pharmacist in primary health care</description>
    <arm_group_label>Educational program and individual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of hypertension (&gt; 140/90 mmHg)&#xD;
&#xD;
          -  Age &gt; 40 years&#xD;
&#xD;
          -  Sitting: USF da Restinga e Extremo Sul - USF Chapéu do Sol and USF Paulo Viaro&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Institutionalized individuals&#xD;
&#xD;
          -  Patients with mental illness or disabling chronic illnesses&#xD;
&#xD;
          -  Users of health services belonging to the supplementary health&#xD;
&#xD;
          -  Individuals with life expectancy less than 1 year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carisi Polanczyc, PhD</last_name>
    <role>Study Director</role>
    <affiliation>UFRGS/HMV</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Moinhos de Vento</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90035-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>September 22, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <last_update_submitted>January 14, 2016</last_update_submitted>
  <last_update_submitted_qc>January 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Rio Grande do Sul</investigator_affiliation>
    <investigator_full_name>Fabiana Viegas Raimundo</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <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/NCT01696318
org study id: U1111-1134-6977
secondary id: HMV - 680
nct id: NCT01696318
lead sponsor: 
collaborator: 
has dmc: Yes
Develop and evaluate a model of organization and management in the management of patients
      with cardiovascular risk factors (hypertension, diabetes mellitus, smoking, obesity, physical
      inactivity, dyslipidemia and family history) in primary care aimed at the compliance, control
      and treatment effectiveness.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Blood Pressure
time frame: Change from baseline in Systolic Blood Pressure at 6 months
arm group label: Educational program
arm group type: No Intervention
description: Educational Program with Professional Physical Education, Pharmacist and Nutritionist
arm group label: Educational program and individual care
arm group type: Experimental
description: Educational program and individual care with professional Physical Education; Pharmacist and Nutritionist
intervention type: Behavioral
intervention name: Support for the Family Health Team
description: Participation in physical educator, dietitian and pharmacist in primary health care
arm group label: Educational program and individual care
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Carisi Polanczyc, PhD
role: Study Director
affiliation: UFRGS/HMV
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Rio Grande do Sul
investigator full name: Fabiana Viegas Raimundo
investigator title: PhD
mesh term: Hypertension