Clinical trial NCT06013709: A Machine Learning Algorithm to Predict Health Clinical Situations in Primary Healthcare for Frail Older Adults.
Official title: A Machine Learning Algorithm to Predict Health Clinical Situations (Fall, Undernutrition Risk, Depression Risk, Heart Failure Risk) and Improv Decision-support Tools in Primary Healthcare for Older Adults Living at Home.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frail Elderly Syndrome
Keywords: frailty
older adults
artificial intelligence
falls
undernutrition
depression
heart failure risk
Lead sponsor: Presage
Sponsor class: INDUSTRY
Collaborators: name: Assistance Publique - Hôpitaux de Paris
name: Assistance Publique Hopitaux De Marseille
First posted: 2023-08-28
Enrollment: 1478
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Frail older adults receiving the help of a home care aide using PRESAGE CARE device in France.

Brief summary: Introduction: We developed a machine learning algorithm to predict the risk of emergency hospitalization within the new 7 to 14 days with a good predictive performance (AUC=0.85). Data recorded by home aides were send in real time to a secure server to be analyzed by our machine learning algorithm, which predicted risk level and displayed it on a secure web-based medical device. This study aims to implement and to evaluate the sensitivity and specificity's predictions of Presage system for four clinical situations with a high impact on unscheduled hospitalization of older adults living at home: falls, risk of depression (is sadder), risk of undernutrition (eat less well) and risk of heart failure (swollen leg).

Methods This is a retrospective observational multicenter study. To gain insight on both short-and middle-term predictions and how the risk factors evolve through different periods of observation, we developed a series of models which predict the risk of future clinical symptoms.

Detailed description: This is a retrospective observational multicenter study. This study was conducted on two distinct cohorts.

Data between January 2020 - February 2023 from 50 home care facilities using PRESAEGE CARE medical device on a daily basis were analyzed. 740 853 data from 27 439 visits by home aides for 1 478 patients. The patients' mean age was 84,89 years (SD = 8.9 years) with a moderate dependency level and the sample included 1 038 women (70%).

PRESAGE CARE is a medical device CE marked to predict emergency hospitalizations. This e-health system is based on a questionnaire focused on functional and clinical autonomy (ie, activities of daily life), possible medical symptoms (eg, fatigue, falls, and pain), changes in behavior (eg, recognition and aggressiveness), and communication with the HA or their surroundings.

Based on these data, some others risks are evaluated and predict by the artificial intelligence algorithm.

This study aims to evaluate the sensitivity and specificity's predictions of PRESAGE CARE system for four clinical situations with a high impact on unscheduled hospitalization of olders adults living at home: falls, risk of depression (is sadder), risk if (eat less well) and risk of heart failure (swollen leg).

The principal objective was the sensitivity and specificity of four events' prediction: falls, "is sadder", "eat less well" and "swollen leg" for non-tautological events (when events no appear in the observation window).

Secondary objective was the sensitivity and specificity of four events' prediction: falls, "is sadder", "eat less well" and "swollen leg" for tautological events (when events appear in the observation window).

Eligibility criteria: Inclusion Criteria:

* frail older adults aged 65 years old and over
* Receive the help of a home care aide using PRESAGE CARE
* All eligible persons were invited to participate and were included if they provided consent

Primary outcomes:
measure: Sensitivity and specificity of four events' prediction: falls, "is sadder", "eat less well" and "swollen leg" for non-tautological events ((when events no appear in the observation window).
timeFrame: between one to six weeks
Secondary outcomes:
measure: Sensitivity and specificity of four events' prediction: falls, "is sadder", "eat less well" and "swollen leg" for tautological events ((when events no appear in the observation window).
timeFrame: between one to six weeks
Other outcomes:
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