Clinical trial NCT03484156: Predictive Platform for PEople aGed and Requiring ASsistancE
Official title: Predictive Platform for PEople aGed and Requiring ASsistancE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: Elderly
Frailty
Tele-monitoring
Disability
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-03-30
Enrollment: 25
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: The occurrence of alerts
timeFrame: 6 months
Secondary outcomes:
measure: The relevance of each alert according to the subjective opinion
timeFrame: 6 months
Other outcomes:
measure: The occurrence of major clinical events
timeFrame: 6 months
measure: The functional autonomy
timeFrame: 6 months
measure: The cognitive autonomy
timeFrame: 6 months
Locations:
city: Toulouse
country: France
facility: University Hospital, Toulouse
state: Midi-Pyrenes
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: Toulouse CHU
name: Antoine Piau, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.