Evaluation of the DETECT'CHUTE CLINIBED Smart Carpet for Elderly People Fall Detection (CLINIBED)

DETECT'CHUTE CLINIBED is a smart carpet equipped with several sensors. Positioned at the foot of the bed, this system allows detecting i) patient fall out of the bed and ii) when patient is not back to bed after a certain time. When one of these two events is detected, the system then sends a short message syteme (SMS) and/or an email to the medical staff. The aim of this clinical study is to test the system ability to detect and transmit alarms for both those events.

In this clinical trial, the investigators will therefore test the alarms positive and negative predictive values for both the events.

Study Overview

• Status: Terminated
• Conditions: Elderly People
• Intervention / Treatment: Device: DETECT'CHUTE CLINIBED

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France
    • CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• residents of the facility free to get up at night (without a barrier)
• residents may or may not be suffering from Alzheimer's disease or related illness.
• having fallen several times in the last 12 months and / or at risk of falling (time up and go test ≥ 20 seconds).

Exclusion Criteria:

• Subject under tutelage
• use of night barriers or other forms of physical restraint deemed necessary by the physician in charge of the unit care or the patient
• Refusal of the resident's relatives.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smart carpet	Device: DETECT'CHUTE CLINIBED; The DETECT'CHUTE carpets will be positioned at night at the foot of the bed and set in motion by the nursing staff as soon as the elderly person goes to bed for the night. They will be withdrawn the next morning after the resident's rise. Each patient will benefit from the mat for 1 month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the positive predictive value of alerts	Evaluation of the positive predictive value of alerts issued by the system. In the event of an alert, caregivers will immediately move to the resident's room to see if the alert has signaled a real fall or no return.	During 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the negative predictive value of alerts	Measure the negative predictive value of fall and fall alerts.	During 30 days
Time limit of the intervention of nurse	After each alarm reception (fall or return) the intervention time will be estimated. Regular rounds made by caregivers at the usual rhythm, and will see the appearance of a fall not signaled by the carpet.	During 30 days

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: François Puissieux, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2018
• Primary Completion (Actual): November 19, 2018
• Study Completion (Actual): November 19, 2018

Study Registration Dates

• First Submitted: February 28, 2018
• First Submitted That Met QC Criteria: March 6, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Actual): November 21, 2018
• Last Update Submitted That Met QC Criteria: November 19, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Elderly people; Fall detection; Smart carpet
• Other Study ID Numbers: 2016_58; 2017-A01910-53 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No