- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06019390
eHealth for Screening Health Risks in Home-Based Older Adults: A Prospective Study (Proxi)
eHealth for Screening Health Risks in Home-Based Older Adults: A Prospective Observational Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jacques-Henry Veyron, MS
- Phone Number: +33 0622152004
- Email: jhveyron@presage.care
Study Contact Backup
- Name: Charlotte THERY, PhD
- Email: cthery@presage.care
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: experimental
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlationbetween standardized test scores and the corresponding risks identified by PRESAGE questionnaire.
Time Frame: 6 months
|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
predictive performance of Presage Care questionnaire for health risk detection
Time Frame: 6 months
|
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.
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Presage_Proxi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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