xml: <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/NCT05972746</url>
    </required_header>
    <id_info>
      <org_study_id>0</org_study_id>
      <nct_id>NCT05972746</nct_id>
    </id_info>
    <brief_title>Telemonitoring Program in the Vulnerable Phase After Hospitalization for Heart Failure</brief_title>
    <official_title>Telemonitoring Program With Electronic Alerts to Improve Outcomes in the Vulnerable Phase After Hospitalization for Heart Failure: A Pragmatic Clinical Trial TREAT - Vulnerable HF</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Instituto Cardiovascular de Buenos Aires</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Instituto Cardiovascular de Buenos Aires</source>
    <oversight_info>
      <has_dmc>Yes</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 pragmatic clinical trial aims to evaluate the impact of a telemonitoring program with an&#xD;
        electronic alert system compared to standard treatment on the perception of self-care in&#xD;
        patients after hospitalization for decompensated HF at 3 months post-discharge. And&#xD;
        secondarily to evaluate its impact on clinical events, NT-proBNP and efficacy and safety to&#xD;
        facilitate the use and titration of the recommended drugs in patients with reduced ejection&#xD;
        fraction at 90 days.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 7, 2022</start_date>
    <completion_date type="Anticipated">November 7, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 7, 2023</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>Self-care behavior</measure>
      <time_frame>90 days</time_frame>
      <description>The EHFScBS scale will be used. It consists of a self-administered questionnaire with 12 items addressing various aspects of patient self-care. Each item is scored from 1 (completely agree/always) to 5 (completely disagree/never). The overall score can range from 12 (best self-care) to 60 (worst self-care)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>NT pro BNP</measure>
      <time_frame>90 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Medication adherence</measure>
      <time_frame>90 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life</measure>
      <time_frame>90 days</time_frame>
      <description>The specific Quality of Life (QoL) related to heart failure will be assessed using the Minnesota Living with Heart Failure Questionnaire (MLHFQ), which consists of 21 items. Participants rate their perceptions of how heart failure and its treatment affect their daily life on a 6-point Likert scale ranging from 0 (no impairment) to 5 (very impaired). Therefore, lower scores indicate better specific QoL related to heart failure, and a change of 5 points is considered the minimum clinically significant change [30]. The MLHFQ yields a total QoL score and separate scores for the physical and emotional well-being sub-scales.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>First readmission for heart failure</measure>
      <time_frame>90 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total number of readmissions for heart failure</measure>
      <time_frame>90 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to achieve the use of Guideline-Directed Medical Therapy</measure>
      <time_frame>90 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients with heart failure and reduced ejection fraction who have an increase in the number of Guideline-Directed Medical Therapy</measure>
      <time_frame>90 days</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">110</enrollment>
    <condition>Heart Failure</condition>
    <condition>Acute Heart Failure</condition>
    <arm_group>
      <arm_group_label>Telemonitoring program with electronic alerts + Standard of care</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard of care</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Telemonitoring with electronic alerts</intervention_name>
      <description>Patients assigned to this group will receive standard care plus a telemonitoring program.</description>
      <arm_group_label>Telemonitoring program with electronic alerts + Standard of care</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Standard of care</intervention_name>
      <description>Standard of care</description>
      <arm_group_label>Standard of care</arm_group_label>
      <arm_group_label>Telemonitoring program with electronic alerts + Standard of care</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years&#xD;
  &#xD;
            -  Hospitalized for acute heart failure (regardless of the level of left ventricular&#xD;
               ejection fraction) within 24 hours of discharge, or with a history of hospitalization&#xD;
               for acute HF within 10 days prior to randomization.&#xD;
  &#xD;
            -  Own a smartphone (Smartphone) with internet Ability to speak and read Spanish.&#xD;
  &#xD;
            -  Residence in the metropolitan area of Buenos Aires&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Alcohol or drug abuse&#xD;
  &#xD;
            -  Kidney failure in hemodialysis,&#xD;
  &#xD;
            -  Inability to use the app (Ex: cognitive impairment, lack of social support, lack of&#xD;
               ability to communicate)&#xD;
  &#xD;
            -  Active cancer&#xD;
  &#xD;
            -  Life expectancy less than 1 year&#xD;
  &#xD;
            -  Candidates for care home or institutional end of life&#xD;
  &#xD;
            -  Severe psychiatric illness&#xD;
  &#xD;
            -  Planned cardiac surgery&#xD;
  &#xD;
            -  Patient unable or unwilling to give informed consent to participate.&#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>Instituto Cardiovascular de Buenos Aires</name>
        <address>
          <city>Buenos Aires</city>
          <state>Ciudad Autónoma De Buenos Aires</state>
          <zip>1428</zip>
          <country>Argentina</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lucrecia Maria Burgos</last_name>
        <phone>541141057500</phone>
        <email>lburgos@icba.com.ar</email>
      </contact>
      <investigator>
        <last_name>Lucrecia M Burgos, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Argentina</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>April 14, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Instituto Cardiovascular de Buenos Aires</investigator_affiliation>
      <investigator_full_name>Lucrecia Maria Burgos</investigator_full_name>
      <investigator_title>Unit coordinator</investigator_title>
    </responsible_party>
    <keyword>telemonitoring</keyword>
    <keyword>Heart Failure</keyword>
    <keyword>Vulnerable phase</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Failure</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05972746
  org study id: 0
  nct id: NCT05972746
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This pragmatic clinical trial aims to evaluate the impact of a telemonitoring program with an
        electronic alert system compared to standard treatment on the perception of self-care in
        patients after hospitalization for decompensated HF at 3 months post-discharge. And
        secondarily to evaluate its impact on clinical events, NT-proBNP and efficacy and safety to
        facilitate the use and titration of the recommended drugs in patients with reduced ejection
        fraction at 90 days.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Self-care behavior
  time frame: 90 days
  description: The EHFScBS scale will be used. It consists of a self-administered questionnaire with 12 items addressing various aspects of patient self-care. Each item is scored from 1 (completely agree/always) to 5 (completely disagree/never). The overall score can range from 12 (best self-care) to 60 (worst self-care)
  measure: NT pro BNP
  time frame: 90 days
  measure: Medication adherence
  time frame: 90 days
  measure: Quality of life
  time frame: 90 days
  description: The specific Quality of Life (QoL) related to heart failure will be assessed using the Minnesota Living with Heart Failure Questionnaire (MLHFQ), which consists of 21 items. Participants rate their perceptions of how heart failure and its treatment affect their daily life on a 6-point Likert scale ranging from 0 (no impairment) to 5 (very impaired). Therefore, lower scores indicate better specific QoL related to heart failure, and a change of 5 points is considered the minimum clinically significant change [30]. The MLHFQ yields a total QoL score and separate scores for the physical and emotional well-being sub-scales.
  measure: First readmission for heart failure
  time frame: 90 days
  measure: Total number of readmissions for heart failure
  time frame: 90 days
  measure: Time to achieve the use of Guideline-Directed Medical Therapy
  time frame: 90 days
  measure: Proportion of patients with heart failure and reduced ejection fraction who have an increase in the number of Guideline-Directed Medical Therapy
  time frame: 90 days
  arm group label: Telemonitoring program with electronic alerts + Standard of care
  arm group type: Experimental
  arm group label: Standard of care
  arm group type: Placebo Comparator
  intervention type: Device
  intervention name: Telemonitoring with electronic alerts
  description: Patients assigned to this group will receive standard care plus a telemonitoring program.
  arm group label: Telemonitoring program with electronic alerts + Standard of care
  intervention type: Other
  intervention name: Standard of care
  description: Standard of care
  arm group label: Standard of care
  arm group label: Telemonitoring program with electronic alerts + Standard of care
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Argentina
  responsible party type: Principal Investigator
  investigator affiliation: Instituto Cardiovascular de Buenos Aires
  investigator full name: Lucrecia Maria Burgos
  investigator title: Unit coordinator
  mesh term: Heart Failure
  sharing ipd: Undecided