<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/NCT02249494</url>
  </required_header>
  <id_info>
    <org_study_id>14-0258</org_study_id>
    <nct_id>NCT02249494</nct_id>
  </id_info>
  <brief_title>Mobile Application to Improve Nutritional Counseling Provided by Primary Care Physicians for Hypertension.</brief_title>
  <official_title>Nutritional Recommendations for Hypertension: Development of Mobile Application for Improve Knowledge in Lifestyle Modification for Primary Care Physicians</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Federal University of Rio Grande do Sul</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate whether the use of a mobile app could improve&#xD;
      knowledge and practice in nutrition counseling performed by primary care physicians in&#xD;
      Brazil.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To optimize the nutritional care in the context of the limitations of available time and&#xD;
      knowledge in medical practice, the present study proposes to develop a tool of nutritional&#xD;
      guidelines for hypertension, easily accessible, based on evidence, and then evaluate its use&#xD;
      among primary care physicians registered in a center telehealth. The use of the mobile&#xD;
      application tool will aim to improve the nutritional counseling, helping with prevention of&#xD;
      other chronic diseases in primary care context.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Change in score of knowledge and ability related to nutritional care.</measure>
    <time_frame>30 days</time_frame>
    <description>For each correct answer, participant will get one point on the knowledge test and for each incorrect answer will get 0. Thus, possible scores will range from 69 to 0. Data based on questions about the abilities will be summarized in a qualitative ranking.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Smartphone (mobile app) &amp; telehealth</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will install and use a mobile application designed to provide nutritional recommendations for hypertensive patients. These recommendations will be based on the DASH diet guidelines appropriate to patient profile: consumption of whole grains, fruits, vegetables, milk or low fat dairy products, lean meats, poultry and fish, nuts, seeds and legumes, amount of fats, oils and sweets, as well as guidelines for salt intake and alcohol. The call service will be offered by the Center for Telehealth Rio Grande do Sul to answer clinic questions with qualified staff and in real time. All physicians who work in Primary Health Care in Brazil can use this call center when they have questions about diagnosis and management of their patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>nutritional counseling &amp; telehealth</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Physicians who are enrolled for this group will continue performing routine nutritional counseling in their clinical practice. The call service will be offered by the Center for Telehealth Rio Grande do Sul to answer clinic questions with qualified staff and in real time. All physicians who work in Primary Health Care in Brazil can use this call service when they have questions about diagnosis and management of their patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>telehealth</intervention_name>
    <description>Use the call service offered by the Center for Telehealth Rio Grande do Sul to answer clinic questions with qualified staff and in real time. All physicians who work in Primary Health Care in Brazil can call when they have questions about diagnosis and management of their patients.</description>
    <arm_group_label>Smartphone (mobile app) &amp; telehealth</arm_group_label>
    <arm_group_label>nutritional counseling &amp; telehealth</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>nutritional counseling</intervention_name>
    <description>Performing routine nutritional counseling in their clinical practice</description>
    <arm_group_label>Smartphone (mobile app) &amp; telehealth</arm_group_label>
    <arm_group_label>nutritional counseling &amp; telehealth</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>smartphone (mobile app)</intervention_name>
    <description>Mobile app, designed to provide nutritional recommendations for hypertensive patients, will be use. The recommendations will be based on the DASH diet guidelines appropriate to the patient profile: consumption of whole grains, fruits, vegetables, milk or low fat dairy products, lean meats, poultry and fish, nuts, seeds and legumes, amount of fats, oils and sweets, as well as guidelines for salt intake and alcohol.</description>
    <arm_group_label>Smartphone (mobile app) &amp; telehealth</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  primary care physicians registered in TelessaúdeRS (Center for Telehealth)&#xD;
&#xD;
          -  primary care physicians who use smartphone or tablet&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not to work in primary care&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Erno Harzheim, doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Rio Grande do Sul</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Núcleo de Telessaúde Técnico-Científico do Rio Grande do Sul. Universidade Federal do Rio Grande do Sul</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande do Sul</state>
        <zip>90430-090</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>March 18, 2015</last_update_submitted>
  <last_update_submitted_qc>March 18, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 19, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nutritional Knowledge</keyword>
  <keyword>Nutritional Counseling</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/NCT02249494
org study id: 14-0258
nct id: NCT02249494
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to investigate whether the use of a mobile app could improve
      knowledge and practice in nutrition counseling performed by primary care physicians in
      Brazil.
To optimize the nutritional care in the context of the limitations of available time and
      knowledge in medical practice, the present study proposes to develop a tool of nutritional
      guidelines for hypertension, easily accessible, based on evidence, and then evaluate its use
      among primary care physicians registered in a center telehealth. The use of the mobile
      application tool will aim to improve the nutritional counseling, helping with prevention of
      other chronic diseases in primary care context.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in score of knowledge and ability related to nutritional care.
time frame: 30 days
description: For each correct answer, participant will get one point on the knowledge test and for each incorrect answer will get 0. Thus, possible scores will range from 69 to 0. Data based on questions about the abilities will be summarized in a qualitative ranking.
arm group label: Smartphone (mobile app) & telehealth
arm group type: Experimental
description: Participants will install and use a mobile application designed to provide nutritional recommendations for hypertensive patients. These recommendations will be based on the DASH diet guidelines appropriate to patient profile: consumption of whole grains, fruits, vegetables, milk or low fat dairy products, lean meats, poultry and fish, nuts, seeds and legumes, amount of fats, oils and sweets, as well as guidelines for salt intake and alcohol. The call service will be offered by the Center for Telehealth Rio Grande do Sul to answer clinic questions with qualified staff and in real time. All physicians who work in Primary Health Care in Brazil can use this call center when they have questions about diagnosis and management of their patients.
arm group label: nutritional counseling & telehealth
arm group type: Placebo Comparator
description: Physicians who are enrolled for this group will continue performing routine nutritional counseling in their clinical practice. The call service will be offered by the Center for Telehealth Rio Grande do Sul to answer clinic questions with qualified staff and in real time. All physicians who work in Primary Health Care in Brazil can use this call service when they have questions about diagnosis and management of their patients.
intervention type: Other
intervention name: telehealth
description: Use the call service offered by the Center for Telehealth Rio Grande do Sul to answer clinic questions with qualified staff and in real time. All physicians who work in Primary Health Care in Brazil can call when they have questions about diagnosis and management of their patients.
arm group label: Smartphone (mobile app) & telehealth
arm group label: nutritional counseling & telehealth
intervention type: Other
intervention name: nutritional counseling
description: Performing routine nutritional counseling in their clinical practice
arm group label: Smartphone (mobile app) & telehealth
arm group label: nutritional counseling & telehealth
intervention type: Device
intervention name: smartphone (mobile app)
description: Mobile app, designed to provide nutritional recommendations for hypertensive patients, will be use. The recommendations will be based on the DASH diet guidelines appropriate to the patient profile: consumption of whole grains, fruits, vegetables, milk or low fat dairy products, lean meats, poultry and fish, nuts, seeds and legumes, amount of fats, oils and sweets, as well as guidelines for salt intake and alcohol.
arm group label: Smartphone (mobile app) & telehealth
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Erno Harzheim, doctor
role: Principal Investigator
affiliation: Federal University of Rio Grande do Sul
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Hypertension