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/NCT06018532</url>
    </required_header>
    <id_info>
      <org_study_id>Presage_IC</org_study_id>
      <nct_id>NCT06018532</nct_id>
    </id_info>
    <brief_title>Medical Monitoring of Older Adults Patients After Discharged From Heart Failure Hospitalization</brief_title>
    <official_title>Medical Monitoring of Older Adults Patients After Discharged From Heart Failure Hospitalization</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Presage</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Assistance Publique Hopitaux De Marseille</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Presage</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>
        Introduction: PRESAGE CARE has developed a solution for early detection of the risk of&#xD;
        emergency department visits and unscheduled hospitalizations. This smartphone-based solution&#xD;
        is used by homecare workers and family caregivers to predict the risk of emergency department&#xD;
        visits and unscheduled hospitalization within one to two weeks.&#xD;
  &#xD;
        Objective: To study the feasibility of a multicenter randomized trial to assess the effects&#xD;
        of a healthcare intervention based on the alert from the Présage Care device after discharge&#xD;
        from hospital for patients hospitalized for heart failure (MCO and SSR).&#xD;
  &#xD;
        Background and participants: This is a feasibility study carried out on two hospital wards&#xD;
        for heart failure patients aged 65 and over (MCO and SSR). Patient's relative will be asked&#xD;
        to fill in a short questionnaire twice a week for each beneficiary, relating to the&#xD;
        beneficiary's daily life (input time not to exceed 2 minutes). This information will be&#xD;
        transmitted in real time to PRESAGE CARE's secure platform (health data host). The study will&#xD;
        last 6 months, with a 3-month inclusion period and an expected average follow-up of 3 months.&#xD;
        It is planned to include 50 to 100 patients, with the same number of caregivers, and to study&#xD;
        recruitment rates, participant satisfaction (hospital doctors, patients, caregivers, general&#xD;
        practitioners), drop-out rates and the usefulness of updating the PRESAGE CARE algorithms in&#xD;
        the context of the risk of re-hospitalization heart failure patients.&#xD;
  &#xD;
        Data collected: In addition to inclusion data to describe the participant population,&#xD;
        informations on emergency department visits, hospitalizations, drugs prescribed and&#xD;
        dispensed, and long-term care status will be extracted from the hospital information system .&#xD;
  &#xD;
        The study will establish the usefulness of conducting a subsequent randomized multicenter&#xD;
        study on the added value of the PRESAGE CARE system for this specific population.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Heart failure is a condition with a poor prognosis, especially in older adults with a&#xD;
        difficult management. Overall, the mortality rate increases with age, rising by 27% per&#xD;
        decade in men and 61% per decade in women.&#xD;
  &#xD;
        The management and monitoring of heart failure rely on the appropriate prescription of drugs&#xD;
        with beneficial effect on heart muscle remodeling (ACE inhibitors, beta-blockers), with a&#xD;
        regular reevaluation for a best efficacy as well as a good bservance of hygienic-dietary&#xD;
        rules such as regular weight control, simple nutritional rules (salt and water intake), and&#xD;
        the maintenance of physical activity and training.&#xD;
  &#xD;
        The main aim of ambulatory services is to detect episodes of decompensation early to treat it&#xD;
        rapidly and prevent hospitalization. In the absence of improvement, hospitalization is&#xD;
        necessary. Once discharged from the health care facility, coordination with the town or host&#xD;
        structure is essential to ensure appropriate continuity of care.&#xD;
  &#xD;
        Poor publications have already shown the benefits of Machine Learning (ML) for predicting&#xD;
        hospitalization and death in heart failure patients. Predictive performance ranges from&#xD;
        average (AUC: 0.55) to very good (AUC 0.8).&#xD;
  &#xD;
        However, to work, these models require a large number of highly medicalized variables&#xD;
        (typically over a hundred, including medication, medical history, ECG....), making them very&#xD;
        difficult to apply in real life.&#xD;
  &#xD;
        On the other hand, satisfactory predictive models (AUC&gt;0.7) have large temporal prediction&#xD;
        windows (1 to 3 years), making health actions difficult to implement.&#xD;
  &#xD;
        To the best of our knowledge, no publication presents a short prediction window (a few weeks)&#xD;
        based on simple models (less than 15 variables with little medicalization).&#xD;
  &#xD;
        The PRESAGE Care medical device makes it possible to observe functional changes potentially&#xD;
        heralding major medical events, and significantly improves predictions compared with&#xD;
        conventional models.&#xD;
  &#xD;
          -  Caregivers fill in an easy-to-use application (less than 2 minutes), create to predict&#xD;
             the risk of a serious event (hospitalization, loss of autonomy, etc.).&#xD;
  &#xD;
          -  An alert is sent to the end-users, who are the healthcare professionals, to trigger a&#xD;
             healthcare intervention that could, in some cases, prevent the situation from&#xD;
             deteriorating, or enable it to be managed in a non-emergency context.&#xD;
  &#xD;
        This study is based on the hypothesize that the use of the PRESAGE CARE device coupled with a&#xD;
        health intervention based on existing health networks could be associated with a lower&#xD;
        incidence of unscheduled re-hospitalization, with no difference in mortality. This study is&#xD;
        based on the hypothesize that the device will be well accepted by beneficiaries, their&#xD;
        relatives and healthcare professionals (satisfaction &gt; 80%), and that the intervention will&#xD;
        not be associated with an increase in healthcare expenditure, as the additional costs&#xD;
        associated with the use of PRESAGE CARE will be offset by the reduction in expenditure linked&#xD;
        to avoided hospitalizations.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Acceptability at inclusion by the patient-relative pair using PRESAGE Care</measure>
      <time_frame>through study completion, an average of 6 months</time_frame>
      <description>Rate of relatives participating in the study (%)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Acceptability of the relative</measure>
      <time_frame>through study completion, an average of 6 months</time_frame>
      <description>a regular follow-up rate, characterization of the caregiver (gender ratio (%), average age (years), status (% of children, % of spouse % of husband, % of others).&#xD;
  Validation : more than 50%</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Relevance of follow-up</measure>
      <time_frame>through study completion, an average of 6 months</time_frame>
      <description>Rate of alerts leading to intervention (%) Satisfaction level of referring physicians</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>impact on emergency hospitalization</measure>
      <time_frame>through study completion, an average of 6 months</time_frame>
      <description>Tracking of re-hospitalization and emergency room admission rates (%) Lost to follow-up rate (%) Average length of stay for re-hospitalization in the facility (days) Time to re-hospitalization or emergency (days)</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Frail Elderly Syndrome</condition>
    <condition>Heart Failure</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>PRESAGE CARE</intervention_name>
      <description>PRESAGE Care informations from the application will be processed by the PRESAGE Care algorithm in real time, and may generate alerts indicating an increased risk of hospitalization or emergency department visits within 7 to 14 days. These alerts will be transmitted to a Care Manager platform, who will analyse the situation, initiate the healthcare intervention and coordinate its implementation. In practice, a care manager (coordinating nurse) will process the alert and carry out an initial assessment of the beneficiary's situation, using the information feedback platform, then by telephone, contacting the older adults beneficiary and the relative. The care manager may or may not implement preventive measures. If necessary, the patient may be offered an outpatient medical consultation, a home visit, a consultation with his or her GP and/or social or paramedical interventions.</description>
      <arm_group_label>Intervention</arm_group_label>
      <other_name>Intervention (nurses and physicians)</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Person aged 65 or over.&#xD;
  &#xD;
            -  Living at home&#xD;
  &#xD;
            -  Moderately dependent, defined as GIR 3, 4 or 5.&#xD;
  &#xD;
            -  Be or have been hospitalized in the last 30 days for heart failure&#xD;
  &#xD;
            -  Have a relative volunteer to enter the PRESAGE questionnaire at least twice a week&#xD;
  &#xD;
            -  Agreeing to take part in the study, or not objecting to the study being carried out,&#xD;
               and whose relative agrees to take part.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  People under 65 years of age&#xD;
  &#xD;
            -  With severe dependency defined by a GIR 1 or 2 group.&#xD;
  &#xD;
            -  Not dependent as defined by a GIR 6 group.&#xD;
  &#xD;
            -  Refusing to take part in the study, or whose relative refuses to take part.&#xD;
  &#xD;
            -  Older adult benefiting from the Prado heart failure program on discharge from&#xD;
               hospital.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jacques-Henry Veyron, MS</last_name>
      <phone>0622152004</phone>
      <phone_ext>+33</phone_ext>
      <email>jhveyron@presage.care</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Charlotte THERY, PhD</last_name>
      <phone>0618312856</phone>
      <phone_ext>+33</phone_ext>
      <email>cthery@presage.care</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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>
  
  
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/NCT06018532
  org study id: Presage_IC
  nct id: NCT06018532
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Introduction: PRESAGE CARE has developed a solution for early detection of the risk of
        emergency department visits and unscheduled hospitalizations. This smartphone-based solution
        is used by homecare workers and family caregivers to predict the risk of emergency department
        visits and unscheduled hospitalization within one to two weeks.
  
        Objective: To study the feasibility of a multicenter randomized trial to assess the effects
        of a healthcare intervention based on the alert from the Présage Care device after discharge
        from hospital for patients hospitalized for heart failure (MCO and SSR).
  
        Background and participants: This is a feasibility study carried out on two hospital wards
        for heart failure patients aged 65 and over (MCO and SSR). Patient's relative will be asked
        to fill in a short questionnaire twice a week for each beneficiary, relating to the
        beneficiary's daily life (input time not to exceed 2 minutes). This information will be
        transmitted in real time to PRESAGE CARE's secure platform (health data host). The study will
        last 6 months, with a 3-month inclusion period and an expected average follow-up of 3 months.
        It is planned to include 50 to 100 patients, with the same number of caregivers, and to study
        recruitment rates, participant satisfaction (hospital doctors, patients, caregivers, general
        practitioners), drop-out rates and the usefulness of updating the PRESAGE CARE algorithms in
        the context of the risk of re-hospitalization heart failure patients.
  
        Data collected: In addition to inclusion data to describe the participant population,
        informations on emergency department visits, hospitalizations, drugs prescribed and
        dispensed, and long-term care status will be extracted from the hospital information system .
  
        The study will establish the usefulness of conducting a subsequent randomized multicenter
        study on the added value of the PRESAGE CARE system for this specific population.
  Heart failure is a condition with a poor prognosis, especially in older adults with a
        difficult management. Overall, the mortality rate increases with age, rising by 27% per
        decade in men and 61% per decade in women.
  
        The management and monitoring of heart failure rely on the appropriate prescription of drugs
        with beneficial effect on heart muscle remodeling (ACE inhibitors, beta-blockers), with a
        regular reevaluation for a best efficacy as well as a good bservance of hygienic-dietary
        rules such as regular weight control, simple nutritional rules (salt and water intake), and
        the maintenance of physical activity and training.
  
        The main aim of ambulatory services is to detect episodes of decompensation early to treat it
        rapidly and prevent hospitalization. In the absence of improvement, hospitalization is
        necessary. Once discharged from the health care facility, coordination with the town or host
        structure is essential to ensure appropriate continuity of care.
  
        Poor publications have already shown the benefits of Machine Learning (ML) for predicting
        hospitalization and death in heart failure patients. Predictive performance ranges from
        average (AUC: 0.55) to very good (AUC 0.8).
  
        However, to work, these models require a large number of highly medicalized variables
        (typically over a hundred, including medication, medical history, ECG....), making them very
        difficult to apply in real life.
  
        On the other hand, satisfactory predictive models (AUC>0.7) have large temporal prediction
        windows (1 to 3 years), making health actions difficult to implement.
  
        To the best of our knowledge, no publication presents a short prediction window (a few weeks)
        based on simple models (less than 15 variables with little medicalization).
  
        The PRESAGE Care medical device makes it possible to observe functional changes potentially
        heralding major medical events, and significantly improves predictions compared with
        conventional models.
  
          -  Caregivers fill in an easy-to-use application (less than 2 minutes), create to predict
             the risk of a serious event (hospitalization, loss of autonomy, etc.).
  
          -  An alert is sent to the end-users, who are the healthcare professionals, to trigger a
             healthcare intervention that could, in some cases, prevent the situation from
             deteriorating, or enable it to be managed in a non-emergency context.
  
        This study is based on the hypothesize that the use of the PRESAGE CARE device coupled with a
        health intervention based on existing health networks could be associated with a lower
        incidence of unscheduled re-hospitalization, with no difference in mortality. This study is
        based on the hypothesize that the device will be well accepted by beneficiaries, their
        relatives and healthcare professionals (satisfaction > 80%), and that the intervention will
        not be associated with an increase in healthcare expenditure, as the additional costs
        associated with the use of PRESAGE CARE will be offset by the reduction in expenditure linked
        to avoided hospitalizations.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Acceptability at inclusion by the patient-relative pair using PRESAGE Care
  time frame: through study completion, an average of 6 months
  description: Rate of relatives participating in the study (%)
  measure: Acceptability of the relative
  time frame: through study completion, an average of 6 months
  description: a regular follow-up rate, characterization of the caregiver (gender ratio (%), average age (years), status (% of children, % of spouse % of husband, % of others).
  Validation : more than 50%
  measure: Relevance of follow-up
  time frame: through study completion, an average of 6 months
  description: Rate of alerts leading to intervention (%) Satisfaction level of referring physicians
  measure: impact on emergency hospitalization
  time frame: through study completion, an average of 6 months
  description: Tracking of re-hospitalization and emergency room admission rates (%) Lost to follow-up rate (%) Average length of stay for re-hospitalization in the facility (days) Time to re-hospitalization or emergency (days)
  arm group label: Intervention
  arm group type: Experimental
  intervention type: Device
  intervention name: PRESAGE CARE
  description: PRESAGE Care informations from the application will be processed by the PRESAGE Care algorithm in real time, and may generate alerts indicating an increased risk of hospitalization or emergency department visits within 7 to 14 days. These alerts will be transmitted to a Care Manager platform, who will analyse the situation, initiate the healthcare intervention and coordinate its implementation. In practice, a care manager (coordinating nurse) will process the alert and carry out an initial assessment of the beneficiary's situation, using the information feedback platform, then by telephone, contacting the older adults beneficiary and the relative. The care manager may or may not implement preventive measures. If necessary, the patient may be offered an outpatient medical consultation, a home visit, a consultation with his or her GP and/or social or paramedical interventions.
  arm group label: Intervention
  other name: Intervention (nurses and physicians)
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jacques-Henry Veyron, MS
  phone: 0622152004
  phone ext: +33
  email: jhveyron@presage.care
  last name: Charlotte THERY, PhD
  phone: 0618312856
  phone ext: +33
  email: cthery@presage.care
  responsible party type: Sponsor
  mesh term: Heart Failure
  sharing ipd: No