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eHealth for Screening Health Risks in Home-Based Older Adults: A Prospective Study (Proxi)

Primary Purpose

Frail Elderly Syndrome, Older

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Presage care
Sponsored by
Presage
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Frail Elderly Syndrome focused on measuring screening tool, prevention, artificial intelligence, geriatric syndromes

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria : family members of individuals aged 65 and above, who are present within the day hospitalization service of Charles-Foix Hospital and able to provide informed consent. Non inclusion criteria refuse to give their consent to participate in the study, or have cognitive impairments or are occasional caregivers.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    experimental

    Arm Description

    Outcomes

    Primary Outcome Measures

    Correlationbetween standardized test scores and the corresponding risks identified by PRESAGE questionnaire.
    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.

    Secondary Outcome Measures

    predictive performance of Presage Care questionnaire for health risk detection
    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.

    Full Information

    First Posted
    August 21, 2023
    Last Updated
    August 24, 2023
    Sponsor
    Presage
    Collaborators
    Assistance Publique - Hôpitaux de Paris
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06019390
    Brief Title
    eHealth for Screening Health Risks in Home-Based Older Adults: A Prospective Study
    Acronym
    Proxi
    Official Title
    eHealth for Screening Health Risks in Home-Based Older Adults: A Prospective Observational Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    May 1, 2024 (Anticipated)
    Study Completion Date
    July 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Presage
    Collaborators
    Assistance Publique - Hôpitaux de Paris

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Frail Elderly Syndrome, Older
    Keywords
    screening tool, prevention, artificial intelligence, geriatric syndromes

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    experimental
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Presage care
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Correlationbetween standardized test scores and the corresponding risks identified by PRESAGE questionnaire.
    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.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    predictive performance of Presage Care questionnaire for health risk detection
    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.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria : family members of individuals aged 65 and above, who are present within the day hospitalization service of Charles-Foix Hospital and able to provide informed consent. Non inclusion criteria refuse to give their consent to participate in the study, or have cognitive impairments or are occasional caregivers.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jacques-Henry Veyron, MS
    Phone
    0622152004
    Ext
    +33
    Email
    jhveyron@presage.care
    First Name & Middle Initial & Last Name or Official Title & Degree
    Charlotte THERY, PhD
    Email
    cthery@presage.care

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    eHealth for Screening Health Risks in Home-Based Older Adults: A Prospective Study

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