A Machine Learning Algorithm to Predict Health Clinical Situations in Primary Healthcare for Frail Older Adults.

NCT ID: NCT06013709

Last Updated: 2023-08-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1478 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-01
• Study Completion Date: 2022-12-01

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).

Conditions

Frail Elderly Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

PRESAE CARE

PRESAGE CARE is a medical device CE marked based on artificial intelligence to prevent and reduce emergency department visits and unplanned hospitalization among frail older adults living at home.

These device is based on the use of a short 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 home care aides (HAs)or their surroundings. This questionnaire is composed of very simple and easy-to-understand questions, giving a global view of the person's condition. For each of the 27 questions, a yes/no answer was requested. Data recorded by HAs were sent in real time to a secure server to be analyzed by our machine learning algorithm, which predicted the risk level on emergency hospitalization risk and some health clinical situations and displayed it on a web-based secure medical device.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: collaborator

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: collaborator

Presage

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

PRESAGE

Identifier Type: -

Identifier Source: org_study_id