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

NCT06019390 | Unknown

• 1 other identifier: Presage_Proxi
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Frail Elderly Syndrome; Older

Keywords

screening tool; prevention; artificial intelligence; geriatric syndromes

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• predictive performance of Presage Care questionnaire for health risk detection

  6 months

Study Arms (1)

experimental

EXPERIMENTAL

Device: Presage care

Interventions

Presage care DEVICE

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.

experimental

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.
• refuse to give their consent to participate in the study,
• or have cognitive impairments
• or are occasional caregivers.

Sponsors & Collaborators

• Presage: lead
• Assistance Publique - Hôpitaux de Paris: collaborator

Central Study Contacts

Jacques-Henry Veyron, MS

CONTACT

0622152004; jhveyron@presage.care

Charlotte THERY, PhD

CONTACT

cthery@presage.care

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 31, 2023
• Study Start: October 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share