Predictive Platform for PEople aGed and Requiring ASsistancE

NCT03484156 | Completed

• 1 other identifier: RC31/15/7803
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Aging

Keywords

Elderly; Frailty; Tele-monitoring; Disability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The relevance of each alert according to the subjective opinion

  6 months

Other Outcomes (3)

• The occurrence of major clinical events

  6 months

• The functional autonomy

  6 months

• The cognitive autonomy

  6 months

Study Arms (1)

Volunteers

EXPERIMENTAL

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.

Device: Installation of 3PEGASE Sensor

Interventions

Installation of 3PEGASE Sensor DEVICE

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

Volunteers

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• patient aged 75 or more, living alone at home
• frail of disable (ADL superior or equal at 3)
• able to walk by themselves

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (2)

University Hospital, Toulouse

Toulouse, Midi-Pyrenes, 31059, France

Location

CHU Toulouse

Toulouse, 31059, France

Location

Related Publications (1)

• 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.

  PMID: 31738180 DERIVED

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Antoine Piau, MD

  Toulouse CHU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: March 30, 2018
• Study Start: September 1, 2017
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: July 12, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)