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/NCT06019390</url>
    </required_header>
    <id_info>
      <org_study_id>Presage_Proxi</org_study_id>
      <nct_id>NCT06019390</nct_id>
    </id_info>
    <brief_title>eHealth for Screening Health Risks in Home-Based Older Adults: A Prospective Study</brief_title>
    <acronym>Proxi</acronym>
    <official_title>eHealth for Screening Health Risks in Home-Based Older Adults: A Prospective Observational Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Presage</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Assistance Publique - Hôpitaux de Paris</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Presage</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Introduction: Due to the worldwide ageing population and the increasing prevalence of chronic&#xD;
        illnesses and cognitive deficits, appropriate instruments for frailty early screening and&#xD;
        assessment of geriatric syndromes are required. Digital tools based on artificial&#xD;
        intelligence can help improve the evaluation and screening of health risks in the older&#xD;
        adults.&#xD;
  &#xD;
        Objectives: This study aims to evaluate the effectiveness of the PRESAGE CARE questionnaire&#xD;
        in screening geriatric syndromes among older adults and to assess its correlation with&#xD;
        standardized test scores of the comprehensive geriatric assessment (CGA).&#xD;
  &#xD;
        Methods: A monocentric prospective observational study will be conducted between October 2023&#xD;
        and July 2024, on seniors who are in the day hospitalization service of Charles-Foix hospital&#xD;
        in France. During the consultation with older adults, the investigators will ask the&#xD;
        patient's home caregiver to use the PRESAGE CARE application to fill in the PRESAGE CARE&#xD;
        questionnaire. Once the questionnaire will be completed on the application, the PRESAGE&#xD;
        platform will automatically recorde specific risks for each senior. Subsequently, the&#xD;
        investigators will retrieve the data from standardized tests conduct on the same day and&#xD;
        enter the results for each patient into the platform.&#xD;
  &#xD;
        The primary outcome will be the correlation between standardized test scores and the risks&#xD;
        computed by the Presage Care system for the risk of depression, the risk of undernutrition,&#xD;
        the risk of cognitive impairment and the risk of loss of autonomy in activities of daily&#xD;
        living.&#xD;
  &#xD;
        Secondary outcome will be the comparison of the Area Under the Median Curve (AUC), and the&#xD;
        sensitivity, specificity and positive predictive values of artificial intelligence (AI)-based&#xD;
        models on the Présage Care questionnaire.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        During the consultation and the assessment of the older adult by the physicians and the&#xD;
        nurses at the day hospitalization service of the hospital, patient's relative fill out&#xD;
        PRESAGE CARE questionnaire. Then, the investigators retrieved the data from the standardized&#xD;
        tests completed the same day by the health professionals and filled in the test results for&#xD;
        each patient on the platform.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 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>Screening</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Correlationbetween standardized test scores and the corresponding risks identified by PRESAGE questionnaire.</measure>
      <time_frame>6 months</time_frame>
      <description>Kendall's correlation coefficient (Tau test) will be used to analyze the correlation between the risks calculated by the Présage Care algorithm and the results of the associated standardized scale.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>predictive performance of Presage Care questionnaire for health risk detection</measure>
      <time_frame>6 months</time_frame>
      <description>For secondary outcoumes, the Chi2 test will be used to compare the high-risk rate and the diagnostic rate for each risk. Presage Care risks will be represented as binary Yes/No variables (at risk/no risk) or as ordinal variables (different levels of risk). Scores on the standardized MNA, GDS15 and MMSE tests will be grouped into binary variables according to the threshold for each test described in the literature, with 0 = &quot;normal&quot; score. For the IADL and ADL scales, the threshold defined represents total autonomy (independence in each of the domains scored). Predictive performance will be assessed by the median area under the curve, sensitivity, specificity, positive predictive value, negative predictive value, Youden index, for each Presage risk with the associated scale score. Data analysis will be performed using R studio (version 2022.07.2+576) and Python software.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Frail Elderly Syndrome</condition>
    <condition>Older</condition>
    <arm_group>
      <arm_group_label>experimental</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>A screening questionnaire completed by the family caregiver focused on functional and clinical autonomy of the patient (ie, activities of daily life), possible medical symptoms (eg, fatigue, falls, and pain), changes in behavior (eg, recognition and aggressiveness), and communication with relative or their surroundings.</description>
      <arm_group_label>experimental</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          -  Inclusion criteria :&#xD;
  &#xD;
                 1. family members of individuals aged 65 and above,&#xD;
  &#xD;
                 2. who are present within the day hospitalization service of Charles-Foix Hospital&#xD;
  &#xD;
                 3. and able to provide informed consent.&#xD;
  &#xD;
            -  Non inclusion criteria&#xD;
  &#xD;
                 1. refuse to give their consent to participate in the study,&#xD;
  &#xD;
                 2. or have cognitive impairments&#xD;
  &#xD;
                 3. or are occasional caregivers.&#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>
      <email>cthery@presage.care</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>screening tool</keyword>
    <keyword>prevention</keyword>
    <keyword>artificial intelligence</keyword>
    <keyword>geriatric syndromes</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Syndrome</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/NCT06019390
  org study id: Presage_Proxi
  nct id: NCT06019390
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Introduction: Due to the worldwide ageing population and the increasing prevalence of chronic
        illnesses and cognitive deficits, appropriate instruments for frailty early screening and
        assessment of geriatric syndromes are required. Digital tools based on artificial
        intelligence can help improve the evaluation and screening of health risks in the older
        adults.
  
        Objectives: This study aims to evaluate the effectiveness of the PRESAGE CARE questionnaire
        in screening geriatric syndromes among older adults and to assess its correlation with
        standardized test scores of the comprehensive geriatric assessment (CGA).
  
        Methods: A monocentric prospective observational study will be conducted between October 2023
        and July 2024, on seniors who are in the day hospitalization service of Charles-Foix hospital
        in France. During the consultation with older adults, the investigators will ask the
        patient's home caregiver to use the PRESAGE CARE application to fill in the PRESAGE CARE
        questionnaire. Once the questionnaire will be completed on the application, the PRESAGE
        platform will automatically recorde specific risks for each senior. Subsequently, the
        investigators will retrieve the data from standardized tests conduct on the same day and
        enter the results for each patient into the platform.
  
        The primary outcome will be the correlation between standardized test scores and the risks
        computed by the Presage Care system for the risk of depression, the risk of undernutrition,
        the risk of cognitive impairment and the risk of loss of autonomy in activities of daily
        living.
  
        Secondary outcome will be the comparison of the Area Under the Median Curve (AUC), and the
        sensitivity, specificity and positive predictive values of artificial intelligence (AI)-based
        models on the Présage Care questionnaire.
  During the consultation and the assessment of the older adult by the physicians and the
        nurses at the day hospitalization service of the hospital, patient's relative fill out
        PRESAGE CARE questionnaire. Then, the investigators retrieved the data from the standardized
        tests completed the same day by the health professionals and filled in the test results for
        each patient on the platform.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Screening
  masking: None (Open Label)
  measure: Correlationbetween standardized test scores and the corresponding risks identified by PRESAGE questionnaire.
  time frame: 6 months
  description: Kendall's correlation coefficient (Tau test) will be used to analyze the correlation between the risks calculated by the Présage Care algorithm and the results of the associated standardized scale.
  measure: predictive performance of Presage Care questionnaire for health risk detection
  time frame: 6 months
  description: For secondary outcoumes, the Chi2 test will be used to compare the high-risk rate and the diagnostic rate for each risk. Presage Care risks will be represented as binary Yes/No variables (at risk/no risk) or as ordinal variables (different levels of risk). Scores on the standardized MNA, GDS15 and MMSE tests will be grouped into binary variables according to the threshold for each test described in the literature, with 0 = "normal" score. For the IADL and ADL scales, the threshold defined represents total autonomy (independence in each of the domains scored). Predictive performance will be assessed by the median area under the curve, sensitivity, specificity, positive predictive value, negative predictive value, Youden index, for each Presage risk with the associated scale score. Data analysis will be performed using R studio (version 2022.07.2+576) and Python software.
  arm group label: experimental
  arm group type: Experimental
  intervention type: Device
  intervention name: Presage care
  description: A screening questionnaire completed by the family caregiver focused on functional and clinical autonomy of the patient (ie, activities of daily life), possible medical symptoms (eg, fatigue, falls, and pain), changes in behavior (eg, recognition and aggressiveness), and communication with relative or their surroundings.
  arm group label: experimental
  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
  email: cthery@presage.care
  responsible party type: Sponsor
  mesh term: Syndrome
  sharing ipd: No