<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/NCT04437849</url>
  </required_header>
  <id_info>
    <org_study_id>0094</org_study_id>
    <nct_id>NCT04437849</nct_id>
  </id_info>
  <brief_title>Home Telemonitoring System for Patients With Heart Failure vs Usual Care</brief_title>
  <official_title>Trial Clínico: Utilidad Del Telemonitoreo en Pacientes Con IC Como Medio de Apoyo Para la autogestión de la Enfermedad</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Nacional de Tucuman</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Nacional de Tucuman</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>
      This randomized controlled clinical trial compares a home telemonitoring system (HTS) versus&#xD;
      usual care during a 90 days follow-up period of Heart Failure (HF) ambulatory patients, in&#xD;
      order to evaluate if the use of the HTS improves quality of life and HF related-knowledge.&#xD;
      The study was reviewed and approved by the Methodological Committee and by the Research&#xD;
      Ethics Committee from the Provincial Health System, according to the Declaration of Helsinki.&#xD;
      Written informed consent was obtained before randomization.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2018</start_date>
  <completion_date type="Actual">May 1, 2019</completion_date>
  <primary_completion_date type="Actual">May 1, 2019</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in quality of life through the Minnesota Living with Heart Failure Questionnaire (MLHFQ)</measure>
    <time_frame>3-month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in HF related knowledge through the Knowledge of CHF questionnaire</measure>
    <time_frame>3-month</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Telemonitoring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Home Telemonitoring System</intervention_name>
    <description>Home Telemonitoring System (HTS) The HTS consists of an App that daily collects measurements of weight, blood pressure, heart rate and symptoms (checklist of symptoms questions). The HTS processes the data and generates and sends an alert to the physicians if a risk situation occurs (measurements are outside of normal ranges). The App has also an educational functionality that allows learning about lifestyle, self-care and healthy habits for HF patients. For this purpose, the application: a) has a section that answers frequent questions, b) has a question and answer game about HF, and c) sends educational messages to the patients every day.</description>
    <arm_group_label>Telemonitoring</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  were over 18 years with a primary diagnosis of HF,&#xD;
&#xD;
          -  had been hospitalized at least once time as a consequence of a HF decompensation,&#xD;
&#xD;
          -  had a Smartphone,&#xD;
&#xD;
          -  had access to WiFi,&#xD;
&#xD;
          -  had access to a weight scale and to a blood-pressure monitor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  illiterate patients,&#xD;
&#xD;
          -  had learning difficulties,&#xD;
&#xD;
          -  had a cognitive impairment sufficient to interfere with the use of the telemonitoring&#xD;
             system, or had a severe depression that could interfere with their quality of life&#xD;
             perception.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Zenón Santillán Health Center Hospital</name>
      <address>
        <city>San Miguel de Tucuman</city>
        <state>Tucuman</state>
        <zip>4000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 16, 2020</last_update_submitted>
  <last_update_submitted_qc>June 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Nacional de Tucuman</investigator_affiliation>
    <investigator_full_name>Lucía María Yanicelli</investigator_full_name>
    <investigator_title>Principal Investigator PhD in Exact Sciences and Engineering</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</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/NCT04437849
org study id: 0094
nct id: NCT04437849
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This randomized controlled clinical trial compares a home telemonitoring system (HTS) versus
      usual care during a 90 days follow-up period of Heart Failure (HF) ambulatory patients, in
      order to evaluate if the use of the HTS improves quality of life and HF related-knowledge.
      The study was reviewed and approved by the Methodological Committee and by the Research
      Ethics Committee from the Provincial Health System, according to the Declaration of Helsinki.
      Written informed consent was obtained before randomization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Changes in quality of life through the Minnesota Living with Heart Failure Questionnaire (MLHFQ)
time frame: 3-month
measure: Changes in HF related knowledge through the Knowledge of CHF questionnaire
time frame: 3-month
arm group label: Telemonitoring
arm group type: Experimental
arm group label: Usual Care
arm group type: No Intervention
intervention type: Device
intervention name: Home Telemonitoring System
description: Home Telemonitoring System (HTS) The HTS consists of an App that daily collects measurements of weight, blood pressure, heart rate and symptoms (checklist of symptoms questions). The HTS processes the data and generates and sends an alert to the physicians if a risk situation occurs (measurements are outside of normal ranges). The App has also an educational functionality that allows learning about lifestyle, self-care and healthy habits for HF patients. For this purpose, the application: a) has a section that answers frequent questions, b) has a question and answer game about HF, and c) sends educational messages to the patients every day.
arm group label: Telemonitoring
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Argentina
responsible party type: Principal Investigator
investigator affiliation: Universidad Nacional de Tucuman
investigator full name: Lucía María Yanicelli
investigator title: Principal Investigator PhD in Exact Sciences and Engineering
mesh term: Heart Failure