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Trial record 5 of 6726 for:    senior citizens

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

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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

Tracking Information
First Submitted Date  ICMJE February 28, 2018
First Posted Date  ICMJE March 7, 2018
Last Update Posted Date November 21, 2018
Actual Study Start Date  ICMJE May 23, 2018
Actual Primary Completion Date November 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03455894 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2018)
  • the negative predictive value of alerts [ Time Frame: During 30 days ]
    Measure the negative predictive value of fall and fall alerts.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the DETECT'CHUTE CLINIBED Smart Carpet for Elderly People Fall Detection
Official Title  ICMJE Evaluation of the DETECT'CHUTE CLINIBED Smart Carpet for Elderly People Fall Detection
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Elderly People
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Smart carpet
Intervention: Device: DETECT'CHUTE CLINIBED
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 19, 2018)
4
Original Estimated Enrollment  ICMJE
 (submitted: March 6, 2018)
25
Actual Study Completion Date  ICMJE November 19, 2018
Actual Primary Completion Date November 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03455894
Other Study ID Numbers  ICMJE 2016_58
2017-A01910-53 ( Other Identifier: ID-RCB number, ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Lille
Study Sponsor  ICMJE University Hospital, Lille
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: François Puissieux, MD,PhD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP