Predictive Platform for PEople aGed and Requiring ASsistancE

Aging Clinical Trial

— 3PEGASE  

Official title:

Predictive Platform for PEople aGed and Requiring ASsistancE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03484156
• Other study ID #: RC31/15/7803
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: July 2019
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 75 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging

Intervention

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

Locations

Country	Name	City	State
France	CHU Toulouse	Toulouse
France	University Hospital, Toulouse	Toulouse	Midi-Pyrenes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	The functional autonomy	The functional autonomy measured every 2 months by the Activities of Daily Living (ADL) score	6 months
Other	The cognitive autonomy	The cognitive autonomy measured every two months by the Mini Mental State Examination (MMSE) score	6 months
Primary	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	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