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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03455894
Recruitment Status : Terminated (deficient inclusion)
First Posted : March 7, 2018
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

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.


Condition or disease Intervention/treatment Phase
Elderly People Device: DETECT'CHUTE CLINIBED Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the DETECT'CHUTE CLINIBED Smart Carpet for Elderly People Fall Detection
Actual Study Start Date : May 23, 2018
Actual Primary Completion Date : November 19, 2018
Actual Study Completion Date : November 19, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

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 They will be withdrawn the next morning after the resident's rise.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




Primary Outcome Measures :
  1. the positive predictive value of alerts [ Time Frame: During 30 days ]
    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.


Secondary Outcome Measures :
  1. the negative predictive value of alerts [ Time Frame: During 30 days ]
    Measure the negative predictive value of fall and fall alerts.

  2. Time limit of the intervention of nurse [ Time Frame: During 30 days ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03455894


Locations
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France
CHU
Lille, France
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: François Puissieux, MD,PhD University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03455894     History of Changes
Other Study ID Numbers: 2016_58
2017-A01910-53 ( Other Identifier: ID-RCB number, ANSM )
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Fall detection
Smart carpet
Elderly people