Clinical Trials Directory

Trials / Completed

CompletedNCT03484156

Predictive Platform for PEople aGed and Requiring ASsistancE

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
25 (actual)
Sponsor
University Hospital, Toulouse · Academic / Other
Sex
All
Age
75 Years
Healthy volunteers
Accepted

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.

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.

Conditions

Interventions

TypeNameDescription
DEVICEInstallation of 3PEGASE SensorVolunteers 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

Timeline

Start date
2017-09-01
Primary completion
2019-07-01
Completion
2019-07-01
First posted
2018-03-30
Last updated
2019-07-12

Locations

2 sites across 1 country: France

Source: ClinicalTrials.gov record NCT03484156. Inclusion in this directory is not an endorsement.