<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/NCT04475367</url>
  </required_header>
  <id_info>
    <org_study_id>5701-19</org_study_id>
    <nct_id>NCT04475367</nct_id>
  </id_info>
  <brief_title>Evaluation of the Effect of an APP in Improving Treatment Adherence in Hypertensive Patients in Hypertension Ambulatory</brief_title>
  <official_title>Evaluation of the Effect of an APP in Improving Treatment Adherence in Hypertensive Patients in Hypertension Ambulatory</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Brief Summary: Through the App, the user will have the opportunity to connect directly with&#xD;
      the health professional, clarify doubts and manage the treatment of their hypertension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate treatment adherence and blood pressure reduction, through the HiperCross App,&#xD;
      between two groups of hypertensive patients in a Hypertension Public Ambulatory in Porto&#xD;
      Alegre.&#xD;
&#xD;
      The investigators hope to identify better adherence to treatment, as well as a significant&#xD;
      reduction in blood pressure, all of these results will be better evaluated using the&#xD;
      HiperCross application.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 10, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 20, 2021</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>
    <intervention_model_description>The participants will be randomized into 2 intervention groups</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>blind research assistant</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Blood pressure value</measure>
    <time_frame>15 minutes</time_frame>
    <description>systolic Blood pressure and dyastolic Blood pressure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Morisky scale</measure>
    <time_frame>15 minutes</time_frame>
    <description>Medication adherence. The Morisky scale condition and medication specific assessment: 1) measures the level of adherence an medication, 2) measures the severity of Major Depressive Disorder, a determinant of non-adherence 3) identifies why the patient is not taking their medication, 4) determines the risk between non-adherence to BP measures of disease control. 0-1 = Low motivation; 2-3 = High motivation / 0-1 = Low knowledge; 2-3 = High knowledge</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">44</enrollment>
  <condition>Blood Pressure</condition>
  <condition>Adhesion</condition>
  <arm_group>
    <arm_group_label>hypertensive patients using HyperCrossApp</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Interdisciplinary health care&#xD;
+ HyperCross App</description>
  </arm_group>
  <arm_group>
    <arm_group_label>hypertensive patients without using HyperCrossApp</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Interdisciplinary health care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>App hypercross group</intervention_name>
    <description>hypertensive patients using HyperCrossApp</description>
    <arm_group_label>hypertensive patients using HyperCrossApp</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>without App hypercross group</intervention_name>
    <description>Interdisciplinary health care</description>
    <arm_group_label>hypertensive patients without using HyperCrossApp</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  hypertensive patients admitted to the hypertension clinic at Instituto de Cardiologia&#xD;
&#xD;
          -  older 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients without a mobile phone compatible with the App&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bruna Eibel, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Post Graduation professor - Cardiology Foundation</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ana Paula Reis, Nurse</last_name>
    <phone>+555132303600</phone>
    <email>areis9874@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Bruna Eibel, PhD</last_name>
    <phone>+555132303600</phone>
    <email>brunaeibel@gmail.com</email>
  </overall_contact_backup>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 18, 2020</last_update_submitted>
  <last_update_submitted_qc>July 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</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>Ana Paula Reis</investigator_full_name>
    <investigator_title>Nurse Specialist</investigator_title>
  </responsible_party>
  <keyword>software</keyword>
  <keyword>hypertension</keyword>
  <keyword>technology</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/NCT04475367
org study id: 5701-19
nct id: NCT04475367
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Brief Summary: Through the App, the user will have the opportunity to connect directly with
      the health professional, clarify doubts and manage the treatment of their hypertension.
To evaluate treatment adherence and blood pressure reduction, through the HiperCross App,
      between two groups of hypertensive patients in a Hypertension Public Ambulatory in Porto
      Alegre.

      The investigators hope to identify better adherence to treatment, as well as a significant
      reduction in blood pressure, all of these results will be better evaluated using the
      HiperCross application.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The participants will be randomized into 2 intervention groups
primary purpose: Screening
masking: Single (Outcomes Assessor)
masking description: blind research assistant
measure: Blood pressure value
time frame: 15 minutes
description: systolic Blood pressure and dyastolic Blood pressure
measure: Morisky scale
time frame: 15 minutes
description: Medication adherence. The Morisky scale condition and medication specific assessment: 1) measures the level of adherence an medication, 2) measures the severity of Major Depressive Disorder, a determinant of non-adherence 3) identifies why the patient is not taking their medication, 4) determines the risk between non-adherence to BP measures of disease control. 0-1 = Low motivation; 2-3 = High motivation / 0-1 = Low knowledge; 2-3 = High knowledge
arm group label: hypertensive patients using HyperCrossApp
arm group type: Experimental
description: Interdisciplinary health care
+ HyperCross App
arm group label: hypertensive patients without using HyperCrossApp
arm group type: Active Comparator
description: Interdisciplinary health care
intervention type: Other
intervention name: App hypercross group
description: hypertensive patients using HyperCrossApp
arm group label: hypertensive patients using HyperCrossApp
intervention type: Other
intervention name: without App hypercross group
description: Interdisciplinary health care
arm group label: hypertensive patients without using HyperCrossApp
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Bruna Eibel, PhD
role: Study Director
affiliation: Post Graduation professor - Cardiology Foundation
last name: Ana Paula Reis, Nurse
phone: +555132303600
email: areis9874@gmail.com
last name: Bruna Eibel, PhD
phone: +555132303600
email: brunaeibel@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Instituto de Cardiologia do Rio Grande do Sul
investigator full name: Ana Paula Reis
investigator title: Nurse Specialist
mesh term: Hypertension