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Clinical Trials/NCT03484156
NCT03484156
Completed
Not Applicable

Predictive Platform for PEople aGed and Requiring ASsistancE

University Hospital, Toulouse2 sites in 1 country25 target enrollmentSeptember 1, 2017
ConditionsAging

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aging
Sponsor
University Hospital, Toulouse
Enrollment
25
Locations
2
Primary Endpoint
The occurrence of alerts
Status
Completed
Last Updated
6 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
September 1, 2017
End Date
July 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

The occurrence of alerts

Time Frame: 6 months

The occurrence of alerts : each alert will be recorded to characterize the number and the pace of alerts during the time of follow-up

Secondary Outcomes

  • The relevance of each alert according to the subjective opinion(6 months)

Study Sites (2)

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