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
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
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
NCT ID
NCT06019390
First Posted
August 21, 2023
Last Updated
August 24, 2023
Sponsor
Presage
Collaborators
Assistance Publique - Hôpitaux de Paris
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
We'll reach out to this number within 24 hrs