<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/NCT04403659</url>
  </required_header>
  <id_info>
    <org_study_id>MONTEROSA</org_study_id>
    <nct_id>NCT04403659</nct_id>
  </id_info>
  <brief_title>Telemonitoring of Patients Admitted in Hospital at Home With Acute Decompensated Heart Failure - Pilot Study</brief_title>
  <acronym>MONTEROSA</acronym>
  <official_title>Monitoraggio Telematico di Pazienti Ricoverati in Ospedalizzazione a Domicilio Per Scompenso Cardiaco Acuto - Studio Pilota</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Ospedaliera Città della Salute e della Scienza di Torino</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Santer Reply S.p.A. Milan, Italy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Caretek S.r.l. Turin, Italy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Azienda Ospedaliera Città della Salute e della Scienza di Torino</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>
      &quot;La Casa nel Parco&quot; (CANP) Project is a multidisciplinary project funded by the European&#xD;
      Union and Regione Piemonte aimed to explore innovative technology application in the care of&#xD;
      older subjects. In this context, MONTEROSA is a monocentric randomized controlled open-label&#xD;
      clinical trial evaluating the use of a telemonitoring/telemedicine (TM) suite (including a&#xD;
      sphygmomanometer, pulse oximeter, weight scale, thermometer, glucometer, electrocardiograph)&#xD;
      as a support to the routine clinical care of patients admitted to a Hospital at Home service&#xD;
      for acute decompensated heart failure.&#xD;
&#xD;
      The main objective of the study will be to evaluate the impact of TM on number of daily&#xD;
      physician's visits. Secondary objectives will be to evaluate the impact of TM on number of&#xD;
      daily nurse visits, on overall in-hospital mortality and on patient's and caregiver's quality&#xD;
      of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 1, 2020</start_date>
  <completion_date type="Anticipated">January 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 31, 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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean daily number of physician visits</measure>
    <time_frame>From allocation through to HaH discharge, in mean 15 days</time_frame>
    <description>Mean daily number of physician visits during Hospital at Home (HaH) stay, defined as total number of physician visits during HaH stay, divided by days of HaH stay, for every single patient</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean daily number of nurse visits</measure>
    <time_frame>From allocation through to HaH discharge, in mean 15 days</time_frame>
    <description>Mean daily number of nurse visits during Hospital at Home (HaH) stay, defined as total number of nurse visits during HaH stay, divided by days of HaH stay, for every single patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean daily number of urgent physician visits</measure>
    <time_frame>From allocation through to HaH discharge, in mean 15 days</time_frame>
    <description>Mean daily number of urgent physician visits during Hospital at Home (HaH) stay, defined as total number of urgent (i.e. unplanned) physician visits during HaH stay, divided by days of HaH stay, for every single patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean daily number of urgent nurse visits</measure>
    <time_frame>From allocation through to HaH discharge, in mean 15 days</time_frame>
    <description>Mean daily number of urgent nurse visits during Hospital at Home (HaH) stay, defined as total number of urgent (i.e. unplanned) nurse visits during HaH stay, divided by days of HaH stay, for every single patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall mortality</measure>
    <time_frame>From allocation through to HaH discharge, in mean 15 days</time_frame>
    <description>Death by any cause during Hospital at Home (HaH) stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's quality of life evaluated through the 12-Item Short Form survey (SF-12)</measure>
    <time_frame>At HaH discharge, in mean 15 days after allocation</time_frame>
    <description>Patient's quality of life evaluated through the 12-Item Short Form survey (SF-12), stratified in Physical component summary (Pcs) and Mental component summary (Mcs), at Hospital at Home (HaH) discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Main caregiver's quality of life evaluated through the 12-Item Short Form survey (SF-12)</measure>
    <time_frame>At patient's HaH discharge, in mean 15 days after allocation</time_frame>
    <description>Main caregiver's quality of life evaluated through the 12-Item Short Form survey (SF-12), stratified in Physical component summary (Pcs) and Mental component summary (Mcs), at Hospital at Home (HaH) discharge</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Heart Failure; With Decompensation</condition>
  <condition>Heart Failure，Congestive</condition>
  <condition>Heart Failure Acute</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of a telemonitoring/telemedicine suite (including a sphygmomanometer, pulse oximeter, weight scale, thermometer, glucometer, electrocardiograph) as a support to the routine clinical care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Routine clinical care, following European Society of Cardiology 2016 Guidelines on Heart failure and Good Clinical Practice guidelines</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Telemedicine/telemonitoring (TM) suite</intervention_name>
    <description>The couples patient/caregiver will receive and trained to use a suite of TM instruments including: sphygmomanometer, pulse oximeter, weight scale, thermometer, glucometer, electrocardiograph. During the intervention phase (i.e. from allocation to exit from the study), the caregiver/patient will be asked to measure twice daily, at prespecified times, the following parameters using TM devices: arterial blood pressure, peripheral arterial haemoglobin saturation, tympanic temperature. Body weight will be evaluated once daily.&#xD;
The TM glucometer and TM electrocardiograph will be used exclusively by healthcare staff in case of patients in need of capillary blood glucose testing and according to clinical needs, respectively. All data will be automatically sent to a central interface and made readily available to physicians and nurses, to enable a prompt clinical response. In case of malfunctioning, a technical support will be ensured.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient admitted in Hospital at Home with signs and/or symptoms of new-onset or&#xD;
             decompensated heart failure, according with the definition of 2016 European Society of&#xD;
             Cardiology (ESC) guidelines on Heart Failure&#xD;
&#xD;
          -  Written informed consent signed by both the patient and the main caregiver&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Main caregiver with low IT skills (e.g. unable to use a smartphone);&#xD;
&#xD;
          -  Patient in whom body weight or accurate daily urine output cannot be measured&#xD;
&#xD;
          -  Patient with history of neoplastic/degenerative disease and with estimated life&#xD;
             expectancy less than 3 months&#xD;
&#xD;
          -  Patient with decompensated liver cirrhosis (Child-Pugh score B o C)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Renata Marinello, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>OAU Città della Salute e della Scienza di Torino, Turin, Italy</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Renata Marinello, MD, PhD</last_name>
    <phone>0116334771</phone>
    <phone_ext>+39</phone_ext>
    <email>rmarinello@cittadellasalute.to.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>S.C. Geriatria e Malattie Metaboliche dell'Osso U, A.O.U. Città della Salute e della Scienza di Torino</name>
      <address>
        <city>Torino</city>
        <state>TO</state>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Tibaldi V, Isaia G, Scarafiotti C, Gariglio F, Zanocchi M, Bo M, Bergerone S, Ricauda NA. Hospital at home for elderly patients with acute decompensation of chronic heart failure: a prospective randomized controlled trial. Arch Intern Med. 2009 Sep 28;169(17):1569-75. doi: 10.1001/archinternmed.2009.267.</citation>
    <PMID>19786675</PMID>
  </reference>
  <reference>
    <citation>Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available. Erratum In: Eur Heart J. 2016 Dec 30;:</citation>
    <PMID>27206819</PMID>
  </reference>
  <reference>
    <citation>Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.</citation>
    <PMID>8628042</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 21, 2020</last_update_submitted>
  <last_update_submitted_qc>May 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Ospedaliera Città della Salute e della Scienza di Torino</investigator_affiliation>
    <investigator_full_name>Dott.ssa RENATA MARINELLO</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Telemedicine</keyword>
  <keyword>Telemonitoring</keyword>
  <keyword>Hospital at Home</keyword>
  <keyword>Home Hospitalization</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>No</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/NCT04403659
org study id: MONTEROSA
nct id: NCT04403659
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
"La Casa nel Parco" (CANP) Project is a multidisciplinary project funded by the European
      Union and Regione Piemonte aimed to explore innovative technology application in the care of
      older subjects. In this context, MONTEROSA is a monocentric randomized controlled open-label
      clinical trial evaluating the use of a telemonitoring/telemedicine (TM) suite (including a
      sphygmomanometer, pulse oximeter, weight scale, thermometer, glucometer, electrocardiograph)
      as a support to the routine clinical care of patients admitted to a Hospital at Home service
      for acute decompensated heart failure.

      The main objective of the study will be to evaluate the impact of TM on number of daily
      physician's visits. Secondary objectives will be to evaluate the impact of TM on number of
      daily nurse visits, on overall in-hospital mortality and on patient's and caregiver's quality
      of life.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Mean daily number of physician visits
time frame: From allocation through to HaH discharge, in mean 15 days
description: Mean daily number of physician visits during Hospital at Home (HaH) stay, defined as total number of physician visits during HaH stay, divided by days of HaH stay, for every single patient
measure: Mean daily number of nurse visits
time frame: From allocation through to HaH discharge, in mean 15 days
description: Mean daily number of nurse visits during Hospital at Home (HaH) stay, defined as total number of nurse visits during HaH stay, divided by days of HaH stay, for every single patient
measure: Mean daily number of urgent physician visits
time frame: From allocation through to HaH discharge, in mean 15 days
description: Mean daily number of urgent physician visits during Hospital at Home (HaH) stay, defined as total number of urgent (i.e. unplanned) physician visits during HaH stay, divided by days of HaH stay, for every single patient
measure: Mean daily number of urgent nurse visits
time frame: From allocation through to HaH discharge, in mean 15 days
description: Mean daily number of urgent nurse visits during Hospital at Home (HaH) stay, defined as total number of urgent (i.e. unplanned) nurse visits during HaH stay, divided by days of HaH stay, for every single patient
measure: Overall mortality
time frame: From allocation through to HaH discharge, in mean 15 days
description: Death by any cause during Hospital at Home (HaH) stay
measure: Patient's quality of life evaluated through the 12-Item Short Form survey (SF-12)
time frame: At HaH discharge, in mean 15 days after allocation
description: Patient's quality of life evaluated through the 12-Item Short Form survey (SF-12), stratified in Physical component summary (Pcs) and Mental component summary (Mcs), at Hospital at Home (HaH) discharge
measure: Main caregiver's quality of life evaluated through the 12-Item Short Form survey (SF-12)
time frame: At patient's HaH discharge, in mean 15 days after allocation
description: Main caregiver's quality of life evaluated through the 12-Item Short Form survey (SF-12), stratified in Physical component summary (Pcs) and Mental component summary (Mcs), at Hospital at Home (HaH) discharge
arm group label: Intervention
arm group type: Experimental
description: Use of a telemonitoring/telemedicine suite (including a sphygmomanometer, pulse oximeter, weight scale, thermometer, glucometer, electrocardiograph) as a support to the routine clinical care
arm group label: Control
arm group type: No Intervention
description: Routine clinical care, following European Society of Cardiology 2016 Guidelines on Heart failure and Good Clinical Practice guidelines
intervention type: Device
intervention name: Telemedicine/telemonitoring (TM) suite
description: The couples patient/caregiver will receive and trained to use a suite of TM instruments including: sphygmomanometer, pulse oximeter, weight scale, thermometer, glucometer, electrocardiograph. During the intervention phase (i.e. from allocation to exit from the study), the caregiver/patient will be asked to measure twice daily, at prespecified times, the following parameters using TM devices: arterial blood pressure, peripheral arterial haemoglobin saturation, tympanic temperature. Body weight will be evaluated once daily.
The TM glucometer and TM electrocardiograph will be used exclusively by healthcare staff in case of patients in need of capillary blood glucose testing and according to clinical needs, respectively. All data will be automatically sent to a central interface and made readily available to physicians and nurses, to enable a prompt clinical response. In case of malfunctioning, a technical support will be ensured.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Renata Marinello, MD, PhD
role: Principal Investigator
affiliation: OAU Città della Salute e della Scienza di Torino, Turin, Italy
last name: Renata Marinello, MD, PhD
phone: 0116334771
phone ext: +39
email: rmarinello@cittadellasalute.to.it
facility: 
country: Italy
citation: Tibaldi V, Isaia G, Scarafiotti C, Gariglio F, Zanocchi M, Bo M, Bergerone S, Ricauda NA. Hospital at home for elderly patients with acute decompensation of chronic heart failure: a prospective randomized controlled trial. Arch Intern Med. 2009 Sep 28;169(17):1569-75. doi: 10.1001/archinternmed.2009.267.
PMID: 19786675
citation: Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available. Erratum In: Eur Heart J. 2016 Dec 30;:
PMID: 27206819
citation: Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
PMID: 8628042
responsible party type: Principal Investigator
investigator affiliation: Azienda Ospedaliera Città della Salute e della Scienza di Torino
investigator full name: Dott.ssa RENATA MARINELLO
investigator title: Principal Investigator
mesh term: Heart Failure
sharing ipd: No