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

Elderly People Clinical Trial

— CLINIBED  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03455894
• Other study ID #: 2016_58
• Secondary ID: 2017-A01910-53
• Status: Terminated
• Phase: N/A
• Start date: May 23, 2018
• Est. completion date: November 19, 2018

Study information

• Verified date: November 2018
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: November 19, 2018
• Est. primary completion date: November 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Elderly People

Intervention

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 They will be withdrawn the next morning after the resident's rise.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.

Locations

Country	Name	City	State
France	CHU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the negative predictive value of alerts	Measure the negative predictive value of fall and fall alerts.	During 30 days
Secondary	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