<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/NCT02230293</url>
  </required_header>
  <id_info>
    <org_study_id>UP 3927-06</org_study_id>
    <nct_id>NCT02230293</nct_id>
  </id_info>
  <brief_title>Assistance Multidisciplinary in Hypertensive Patient: Randomized Clinical Trial</brief_title>
  <acronym>MULTIHAS</acronym>
  <official_title>Assistance Multidisciplinary in Hypertensive Patient: Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto de Cardiologia do Rio Grande do Sul</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto de Cardiologia do Rio Grande do Sul</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if multidisciplinary care improves the health&#xD;
      condition of hypertensives.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A multidisciplinary approach in managing hypertensive patients has shown benefits in reducing&#xD;
      blood pressure and risk factors for hypertension.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2008</start_date>
  <completion_date type="Actual">August 2011</completion_date>
  <primary_completion_date type="Actual">August 2011</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in Systolic and Diastolic Blood pressure</measure>
    <time_frame>Measured at the first appointment and 1 year later</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">124</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Conventional Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional treatment and follow up</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multidisciplinary Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multidisciplinary assistance</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Multidisciplinary assistance</intervention_name>
    <description>Multidisciplinary group assistance was effected every two months by all professionals (physician, nurse, dietitian, physiotherapist and psychologist) and consisted in orientations and mechanisms to medication and non-pharmacological adherence (lifestyle changes).</description>
    <arm_group_label>Multidisciplinary Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional treatment and follow up</intervention_name>
    <description>Assistance was effected by physician and nurse and consisted about adapting to the drug</description>
    <arm_group_label>Conventional Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Above 18 years of age&#xD;
&#xD;
          -  Diagnosis of hypertension&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Secondary hypertension&#xD;
&#xD;
          -  Hypertensive patients with congenital cardiopathy&#xD;
&#xD;
          -  Surgical patients&#xD;
&#xD;
          -  Proven myocardial infarction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>41 Years</minimum_age>
    <maximum_age>67 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Silvia Goldmeier, Dr</last_name>
    <role>Study Chair</role>
    <affiliation>Instituto de Cardiologia do Rio Grande do Sul</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto de Cardiologia do Rio Grande do Sul</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90620-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>September 2, 2014</last_update_submitted>
  <last_update_submitted_qc>September 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto de Cardiologia do Rio Grande do Sul</investigator_affiliation>
    <investigator_full_name>Silvia Goldmeier</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>ambulatory care,</keyword>
  <keyword>hypertension,</keyword>
  <keyword>health personnel,</keyword>
  <keyword>clinical trial</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/NCT02230293
org study id: UP 3927-06
nct id: NCT02230293
lead sponsor: 
has dmc: No
The purpose of this study is to determine if multidisciplinary care improves the health
      condition of hypertensives.
A multidisciplinary approach in managing hypertensive patients has shown benefits in reducing
      blood pressure and risk factors for hypertension.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from Baseline in Systolic and Diastolic Blood pressure
time frame: Measured at the first appointment and 1 year later
arm group label: Conventional Group
arm group type: Active Comparator
description: Conventional treatment and follow up
arm group label: Multidisciplinary Group
arm group type: Experimental
description: Multidisciplinary assistance
intervention type: Other
intervention name: Multidisciplinary assistance
description: Multidisciplinary group assistance was effected every two months by all professionals (physician, nurse, dietitian, physiotherapist and psychologist) and consisted in orientations and mechanisms to medication and non-pharmacological adherence (lifestyle changes).
arm group label: Multidisciplinary Group
intervention type: Other
intervention name: Conventional treatment and follow up
description: Assistance was effected by physician and nurse and consisted about adapting to the drug
arm group label: Conventional Group
criteria: 
gender: All
minimum age: 41 Years
maximum age: 67 Years
healthy volunteers: No
last name: Silvia Goldmeier, Dr
role: Study Chair
affiliation: Instituto de Cardiologia do Rio Grande do Sul
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Instituto de Cardiologia do Rio Grande do Sul
investigator full name: Silvia Goldmeier
investigator title: Doctor
mesh term: Hypertension