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

Toulouse University Hospital

Status: Completed

Conditions: Aging

Treatments: Device: Installation of 3PEGASE Sensor

Study type: Interventional

Funder types: Other

Identifiers

NCT03484156

RC31/15/7803

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 75+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Volunteers

Experimental group

Description:

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.

Treatment:

Device: Installation of 3PEGASE Sensor