<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/NCT03005470</url>
  </required_header>
  <id_info>
    <org_study_id>CAAE: 31423214.0.0000.5327</org_study_id>
    <nct_id>NCT03005470</nct_id>
  </id_info>
  <brief_title>Technology for Innovative Monitoring of Cardiovascular Prevention: a RCT</brief_title>
  <acronym>TIM</acronym>
  <official_title>Technology for Innovative Monitoring of Cardiovascular Prevention: A Precision Randomized Controlled Trial</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      National and international guidelines that guide evidence-based clinical practice advocate an&#xD;
      effort to improve blood pressure control based on changing lifestyle and use of blood&#xD;
      pressure lowering medication. However, the effectiveness of the approach usually depends on&#xD;
      patient adherence to both types of interventions - pharmacological and behavioral. Lack of&#xD;
      success on blood pressure control has increased the scope of interventions to improve&#xD;
      adherence and to reduce cardiovascular risk factors without overburdening the public health&#xD;
      system. The use of technologies - mobile or smart phones, games, blogs, internet and video&#xD;
      conferencing - to implement interventions can reduce costs and increase coverage.&#xD;
&#xD;
      Interactive interventions have been associated with a reduction in systolic blood pressure of&#xD;
      3-8 mmHg in patients with hypertension. These interventions were individually tailored to&#xD;
      patient specificities and involved self-monitoring of blood pressure and lifestyle changes,&#xD;
      including regular physical activity, DASH diet, restriction of dietary salt intake, and&#xD;
      weight control. However, the effectiviness of these interventions may have short half-lives&#xD;
      without periodic reinforcement, either to adhere to pharmacological treatment or behavioral&#xD;
      changes. Innovative technologies can be used to achieve lasting effect and even greater blood&#xD;
      pressure reduction.&#xD;
&#xD;
      Therefore, the purpose of this study is to compare effectiveness of four strategies to reduce&#xD;
      blood pressure and improve lifestyle.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a factorial randomized controlled trial of comparative effectiveness and precision&#xD;
      medicine. Participants will be randomly assigned in a ratio of 1:1:2:1 to one of four arms:&#xD;
      telemonitoring of blood pressure by smart phone, text message for lifestyle changes, both&#xD;
      interventions (telemonitoring and messages) or usual clinical care. At randomization, all&#xD;
      participants will receive a printed booklet with lifestyle modification guidelines. The&#xD;
      standardized recommendation to adhere to the pharmacological treatment prescribed by the&#xD;
      attending physician will also be implemented. These types of interventions do not allow the&#xD;
      research assistant responsible for monitoring to be blinded, but the researcher resposible&#xD;
      for the assessment of the outcome will be blinded to the allocated arm and the results will&#xD;
      be evaluated through objective measurements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">February 2019</completion_date>
  <primary_completion_date type="Anticipated">February 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <intervention_model_description>This is a factorial randomized controlled trial (Figure 1) of effectiveness of the use of technologies - smartphones and blood pressure monitoring - to reduce systolic blood pressure and change lifestyle.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Participants have uncontrolled hypertension under on pharmacological treatment. They will be requested not to change drugs and medicine doses during the trial.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Ambulatory blood pressure monitoring (ABPM)</measure>
    <time_frame>Change at six months (end of the trial)</time_frame>
    <description>Reduction in 24h-systolic blood pressure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ABPM</measure>
    <time_frame>Change at six months (end of the trial)</time_frame>
    <description>Reduction in 24h-diastolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other ABPM measurements</measure>
    <time_frame>Change from baseline to end of the trial</time_frame>
    <description>Reduction in daytime and nighttime systolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Office blood pressure</measure>
    <time_frame>At six months (end of the trial)</time_frame>
    <description>Office blood pressure control rate: &lt;130/80 mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in sodium urinary excretion</measure>
    <time_frame>Change at six months (end of the trial)</time_frame>
    <description>Reduction in sodium urinary excretion in a urinary spot</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of lifestyle: increase of regular physical activity, intake of DASH-type diet, or weight reduction</measure>
    <time_frame>Change at six months (end of the trial)</time_frame>
    <description>Increase in average steps taken during 7 days, using pedometer; reported dietary intake using 24h recall of food groups; reduction of reported intake, using a quantitative questionnaire; or reduction of at least 3 kg or the average reduction</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">231</enrollment>
  <condition>Blood Pressure, High</condition>
  <condition>Prehypertension</condition>
  <arm_group>
    <arm_group_label>TELEM group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the telemonitoring home blood pressure group will receive an oscillometric monitor to measure blood pressure at home for six months. Measurements will be made for at least five days a week (including one day during the weekend). Each blood pressure measure will be sent to the center of the study coordination center through software downloaded on the participant's smartphone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TELEMEV group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the telemonitoring of lifestyle group, participants will receive customized standardized text messages to stimulate lifestyle changes and adherence to blood pressure lowering medication. The messages will be focused on the adoption of DASH diet, sodium restriction, increase of physical activity, weight control and adherence to drug treatment. They will be sent to the smarphones on four of the five days of the week at random times using a software developed for this study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TELEM-TELEMEV group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the telemonitoring home blood pressure plus telemonitoring of lifestyle group (TELEM-TELEMEV) will receive both interventions as previously described.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual clinical treatment (UCT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in the control group will be under antihypertensive treatment, chosen at the discretion of the assistant physician. Participants will not receive any technological tool to stimulate blood pressure control or lifestyle modification.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TELEM</intervention_name>
    <description>Participants in the telemonitoring home blood pressure (TELEM) group will receive an oscillometric monitor to measure blood pressure at home for six months. Measurements will be made early in the morning (5:00 to 10:00) and in the evening (18:00 to 21:00) for at least five days a week (including one day during the weekend). Each blood pressure measure will be sent to the center of the study coordination center through software downloaded on the participant's smartphone.</description>
    <arm_group_label>TELEM group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TELEMEV</intervention_name>
    <description>In the lifestyle telemonitoring group (TELEMEV), participants will receive customized standardized text messages to stimulate lifestyle changes and adherence to blood pressure lowering medication. The messages will be focused on the adoption of DASH diet, sodium restriction, increase of physical activity, weight control and adherence to drug treatment. They will be sent out on four of the five days of the week at random times. The messages will be sent to the smarphones through a software developed for this study.</description>
    <arm_group_label>TELEMEV group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TELEM-TELEMEV</intervention_name>
    <description>Participants in the TELEM plus TELEMEV (TELEM-TELEMEV) will receive both interventions as previously described.</description>
    <arm_group_label>TELEM-TELEMEV group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>UCT</intervention_name>
    <description>Participants in the control group will receive usual clinical treatment (UCT) on pre-scheduled visits, but will not receive any technological tool to stimulate blood pressure control or lifestyle modification.</description>
    <arm_group_label>Usual clinical treatment (UCT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Office blood pressure: systolic blood pressure greater or equal to 135 mmHg and below&#xD;
             180 mmHg or diastolic blood pressure greater or equal to 85 mmhg and below 110 mmhg&#xD;
&#xD;
          -  Ambulatory Blood Pressure Monitoring (ABPM): 24h-SBP ≥130 mmHg or 24h-DBP ≥80 mmHg&#xD;
&#xD;
          -  Use of one or two blood pressure lowering drugs&#xD;
&#xD;
          -  Have a smartphone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiovascular event in the last 6 months (eg myocardial infarction, stroke, pacemaker&#xD;
             or other use)&#xD;
&#xD;
          -  Life threatening conditions, low life expectancy&#xD;
&#xD;
          -  Inability to measure blood pressure;&#xD;
&#xD;
          -  Previous diagnosis of secondary hypertension;&#xD;
&#xD;
          -  IF WOMAN: lactating, pregnancy or who intend to become pregnant within the next 6&#xD;
             months.&#xD;
&#xD;
          -  Unable to understand the interventions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sandra C Fuchs</last_name>
    <role>Principal Investigator</role>
    <affiliation>HCPA, UFRGS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de Clinicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90035-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>December 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>April 24, 2018</last_update_submitted>
  <last_update_submitted_qc>April 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital de Clinicas de Porto Alegre</investigator_affiliation>
    <investigator_full_name>Sandra Costa Fuchs</investigator_full_name>
    <investigator_title>Professor Sandra C. Fuchs, MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Prehypertension</keyword>
  <keyword>Hypertension</keyword>
  <keyword>Blood pressure</keyword>
  <keyword>Intervention</keyword>
  <keyword>Lifestyle</keyword>
  <keyword>Blood pressure monitoring</keyword>
  <keyword>Ambulatory Blood Pressure Monitoring</keyword>
  <keyword>Text Messages</keyword>
  <keyword>High blood pressure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prehypertension</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03005470
org study id: CAAE: 31423214.0.0000.5327
nct id: NCT03005470
lead sponsor: 
collaborator: 
has dmc: Yes
National and international guidelines that guide evidence-based clinical practice advocate an
      effort to improve blood pressure control based on changing lifestyle and use of blood
      pressure lowering medication. However, the effectiveness of the approach usually depends on
      patient adherence to both types of interventions - pharmacological and behavioral. Lack of
      success on blood pressure control has increased the scope of interventions to improve
      adherence and to reduce cardiovascular risk factors without overburdening the public health
      system. The use of technologies - mobile or smart phones, games, blogs, internet and video
      conferencing - to implement interventions can reduce costs and increase coverage.

      Interactive interventions have been associated with a reduction in systolic blood pressure of
      3-8 mmHg in patients with hypertension. These interventions were individually tailored to
      patient specificities and involved self-monitoring of blood pressure and lifestyle changes,
      including regular physical activity, DASH diet, restriction of dietary salt intake, and
      weight control. However, the effectiviness of these interventions may have short half-lives
      without periodic reinforcement, either to adhere to pharmacological treatment or behavioral
      changes. Innovative technologies can be used to achieve lasting effect and even greater blood
      pressure reduction.

      Therefore, the purpose of this study is to compare effectiveness of four strategies to reduce
      blood pressure and improve lifestyle.
This is a factorial randomized controlled trial of comparative effectiveness and precision
      medicine. Participants will be randomly assigned in a ratio of 1:1:2:1 to one of four arms:
      telemonitoring of blood pressure by smart phone, text message for lifestyle changes, both
      interventions (telemonitoring and messages) or usual clinical care. At randomization, all
      participants will receive a printed booklet with lifestyle modification guidelines. The
      standardized recommendation to adhere to the pharmacological treatment prescribed by the
      attending physician will also be implemented. These types of interventions do not allow the
      research assistant responsible for monitoring to be blinded, but the researcher resposible
      for the assessment of the outcome will be blinded to the allocated arm and the results will
      be evaluated through objective measurements.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: This is a factorial randomized controlled trial (Figure 1) of effectiveness of the use of technologies - smartphones and blood pressure monitoring - to reduce systolic blood pressure and change lifestyle.
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: Participants have uncontrolled hypertension under on pharmacological treatment. They will be requested not to change drugs and medicine doses during the trial.
measure: Ambulatory blood pressure monitoring (ABPM)
time frame: Change at six months (end of the trial)
description: Reduction in 24h-systolic blood pressure
measure: ABPM
time frame: Change at six months (end of the trial)
description: Reduction in 24h-diastolic blood pressure
measure: Other ABPM measurements
time frame: Change from baseline to end of the trial
description: Reduction in daytime and nighttime systolic blood pressure
measure: Office blood pressure
time frame: At six months (end of the trial)
description: Office blood pressure control rate: <130/80 mmHg
measure: Reduction in sodium urinary excretion
time frame: Change at six months (end of the trial)
description: Reduction in sodium urinary excretion in a urinary spot
measure: Improvement of lifestyle: increase of regular physical activity, intake of DASH-type diet, or weight reduction
time frame: Change at six months (end of the trial)
description: Increase in average steps taken during 7 days, using pedometer; reported dietary intake using 24h recall of food groups; reduction of reported intake, using a quantitative questionnaire; or reduction of at least 3 kg or the average reduction
arm group label: TELEM group
arm group type: Experimental
description: Participants in the telemonitoring home blood pressure group will receive an oscillometric monitor to measure blood pressure at home for six months. Measurements will be made for at least five days a week (including one day during the weekend). Each blood pressure measure will be sent to the center of the study coordination center through software downloaded on the participant's smartphone.
arm group label: TELEMEV group
arm group type: Experimental
description: In the telemonitoring of lifestyle group, participants will receive customized standardized text messages to stimulate lifestyle changes and adherence to blood pressure lowering medication. The messages will be focused on the adoption of DASH diet, sodium restriction, increase of physical activity, weight control and adherence to drug treatment. They will be sent to the smarphones on four of the five days of the week at random times using a software developed for this study.
arm group label: TELEM-TELEMEV group
arm group type: Experimental
description: Participants in the telemonitoring home blood pressure plus telemonitoring of lifestyle group (TELEM-TELEMEV) will receive both interventions as previously described.
arm group label: Usual clinical treatment (UCT)
arm group type: Active Comparator
description: Participants in the control group will be under antihypertensive treatment, chosen at the discretion of the assistant physician. Participants will not receive any technological tool to stimulate blood pressure control or lifestyle modification.
intervention type: Device
intervention name: TELEM
description: Participants in the telemonitoring home blood pressure (TELEM) group will receive an oscillometric monitor to measure blood pressure at home for six months. Measurements will be made early in the morning (5:00 to 10:00) and in the evening (18:00 to 21:00) for at least five days a week (including one day during the weekend). Each blood pressure measure will be sent to the center of the study coordination center through software downloaded on the participant's smartphone.
arm group label: TELEM group
intervention type: Device
intervention name: TELEMEV
description: In the lifestyle telemonitoring group (TELEMEV), participants will receive customized standardized text messages to stimulate lifestyle changes and adherence to blood pressure lowering medication. The messages will be focused on the adoption of DASH diet, sodium restriction, increase of physical activity, weight control and adherence to drug treatment. They will be sent out on four of the five days of the week at random times. The messages will be sent to the smarphones through a software developed for this study.
arm group label: TELEMEV group
intervention type: Device
intervention name: TELEM-TELEMEV
description: Participants in the TELEM plus TELEMEV (TELEM-TELEMEV) will receive both interventions as previously described.
arm group label: TELEM-TELEMEV group
intervention type: Other
intervention name: UCT
description: Participants in the control group will receive usual clinical treatment (UCT) on pre-scheduled visits, but will not receive any technological tool to stimulate blood pressure control or lifestyle modification.
arm group label: Usual clinical treatment (UCT)
criteria: 
gender: All
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: No
last name: Sandra C Fuchs
role: Principal Investigator
affiliation: HCPA, UFRGS
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Hospital de Clinicas de Porto Alegre
investigator full name: Sandra Costa Fuchs
investigator title: Professor Sandra C. Fuchs, MD, PhD
mesh term: Prehypertension
mesh term: Hypertension
sharing ipd: Undecided