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

NCT03455894 | Terminated

• 2 other identifiers: 2016_582017-A01910-53
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Elderly People

Keywords

Fall detection; Smart carpet; Elderly people

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• the negative predictive value of alerts

  During 30 days

• Time limit of the intervention of nurse

  During 30 days

Study Arms (1)

Smart carpet

EXPERIMENTAL

Device: DETECT'CHUTE CLINIBED

Interventions

DETECT'CHUTE CLINIBED DEVICE

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 They will be withdrawn the next morning after the resident's rise.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

Smart carpet

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

CHU

Lille, France

Location

Study Officials

• François Puissieux, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 7, 2018
• Study Start: May 23, 2018
• Primary Completion: November 19, 2018
• Study Completion: November 19, 2018
• Last Updated: November 21, 2018

Record last verified: 2018-11

Locations

FR (1)