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

P

Presage

Status

Not yet enrolling

Conditions

Older
Frail Elderly Syndrome

Treatments

Device: Presage care

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06019390
Presage_Proxi

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

  • Inclusion criteria :

    1. family members of individuals aged 65 and above,
    2. who are present within the day hospitalization service of Charles-Foix Hospital
    3. and able to provide informed consent.
  • Non inclusion criteria

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

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

200 participants in 1 patient group

experimental
Experimental group
Treatment:
Device: Presage care

Trial contacts and locations

0

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Central trial contact

Jacques-Henry Veyron, MS; Charlotte THERY, PhD

Data sourced from clinicaltrials.gov

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