Predictive Platform for PEople aGed and Requiring ASsistancE (3PEGASE)

The study aim is to assess the capacity of a technological solution for analyzing older person's functional and cognitive autonomy at home. Results from this study will also be used to elaborate the design of a further larger national multicenter randomized control trial assessing the efficacy of the solution to detect early infra-clinical disability.

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Device: Installation of 3PEGASE Sensor

Detailed Description

The object of the present project is to evaluate an instrument for monitoring functional and cognitive autonomy in frail or disable elderly persons living alone at home. By assessing older person's autonomy at home and detecting early infra-clinical indicators, the solution could provide relevant clinical parameters to the caregivers and healthcare professionals in order to support the patient's follow-up, and support the detection of preliminary signs of functional loss. The device consists of a set of sensors embedded in the house with minimal invasiveness. The solution transmits the collected data to a remote storage server. Data will then be available for distance consultations by users (i.e., patients, careers or physicians). The study will conduct a wide range of evaluations of the device (technical, clinical, and economic), which will allow the optimization of the prototype. The evaluation of the solution will involve 25 frail or disable community-dwelling subjects living alone for 6 months. Comprehensive assessments will be conducted to highlight the feasibility, integration in healthcare network, and clinical relevance of the technological device.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • CHU Toulouse
  • Midi-Pyrenes
    • Toulouse, Midi-Pyrenes, France, 31059
      • University Hospital, Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patient aged 75 or more, living alone at home
• frail of disable (ADL superior or equal at 3)
• able to walk by themselves

Exclusion Criteria:

• patient presenting a Mini Mental State lower at 16/30 and without a daily intervention from a caregiver
• non agreement of study participation of patients or the reliable person when appropriate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Volunteers; The Installation of 3PEGASE Sensor in elders volunteers to monitor clinical indicators at home.The instrument is for monitoring functional and cognitive autonomy in frail or disable elderly persons living alone at home. The volunteers will have 70 years old or more, living alone at home, frail of disable (ADL> or =3) and able to walk by themselves.

Device: Installation of 3PEGASE Sensor; Volunteers will be equipped with the 3-PEGASE solution to monitor clinical indicators at home : By assessing older person's autonomy at home and detecting early infra-clinical indicators, the solution could provide relevant clinical parameters to the caregivers and healthcare professionals in order to support the patient's follow-up, and support the detection of preliminary signs of functional loss

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The occurrence of alerts	The occurrence of alerts : each alert will be recorded to characterize the number and the pace of alerts during the time of follow-up	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The relevance of each alert according to the subjective opinion	The relevance of each alert if it's legitimate or not legitimate according to the subjective opinion of ; the investigator and the voluntary subject The "Classic" alerts (volunteers on behalf of the person being followed) generated by the system will be defined as valid or invalid on the basis of the carers' assessment: "was he legitimate to alert you? And professionals (assistance). The "automatic" alerts generated by the sensors will be defined as valid or not on the basis of the assessment of the tele-assistant, the carer and the voluntary subject.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The occurrence of major clinical events	The occurrence of major clinical events collected by the Clinical Research Assistant every 2 months a clinical event that required to bring in a doctor, firefighters, a call to 15 or at SOS doctor, a transport to an emergency service	6 months
The functional autonomy	The functional autonomy measured every 2 months by the Activities of Daily Living (ADL) score	6 months
The cognitive autonomy	The cognitive autonomy measured every two months by the Mini Mental State Examination (MMSE) score	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Antoine Piau, MD, Toulouse Chu

Publications and helpful links

General Publications

• Piau A, Lepage B, Bernon C, Gleizes MP, Nourhashemi F. Real-Time Detection of Behavioral Anomalies of Older People Using Artificial Intelligence (The 3-PEGASE Study): Protocol for a Real-Life Prospective Trial. JMIR Res Protoc. 2019 Nov 18;8(11):e14245. doi: 10.2196/14245.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: June 15, 2017
• First Submitted That Met QC Criteria: March 23, 2018
• First Posted (Actual): March 30, 2018

Study Record Updates

• Last Update Posted (Actual): July 12, 2019
• Last Update Submitted That Met QC Criteria: July 11, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Elderly; Frailty; Disability; Tele-monitoring
• Other Study ID Numbers: RC31/15/7803

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No