Elderly PeopleCLINIBEDNCT03455894
Evaluation of the DETECT'CHUTE CLINIBED Smart Carpet for Elderly People Fall Detection
A study testing DETECT'CHUTE CLINIBED in people with Elderly People, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Elderly People
- What is being tested?
- DETECT'CHUTE CLINIBED
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2018to 19 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- DETECT'CHUTE CLINIBED
- Keywords
- Fall detection, Smart carpet, Elderly people
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DETECT'CHUTE CLINIBEDDevice
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 group | Role | What they receive |
|---|---|---|
| Smart carpet | Experimental | Not described Receives: Device: DETECT'CHUTE CLINIBED |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During 30 days
Secondary outcomes (2)
the negative predictive value of alerts
Measure the negative predictive value of fall and fall alerts.
Measured: 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.
Measured: During 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start23 May 2018
- Primary completion19 Nov 2018
- Study completion19 Nov 2018
Why it stopped: deficient inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly PeopleStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Puissieux, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455894
- Sponsor's protocol ID
- 2016_58
- Other IDs
- 2017-A01910-53
- Acronym
- CLINIBED
- Status last verified
- Nov 2018
- First submitted
- 28 Feb 2018
- Last updated
- 21 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the DETECT'CHUTE CLINIBED Smart Carpet for Elderly People Fall Detection
- ClinicalTrials.gov ID
- NCT03455894
- Acronym / sponsor ID
- CLINIBED / 2016_58
- Conditions
- Elderly People
- Keywords
- Fall detection, Smart carpet, Elderly people
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: deficient inclusion
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 23 May 2018 (actual)
- Primary completion
- 19 Nov 2018 (actual)
- Study completion
- 19 Nov 2018 (actual)
- First posted
- 7 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smart carpet | Experimental | Device: DETECT'CHUTE CLINIBED |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DETECT'CHUTE CLINIBEDThe 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. | Device | Smart carpet |
Primary outcome
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.
2 secondary outcomes
the negative predictive value of alerts
Time frame: During 30 days
Time limit of the intervention of nurse
Time frame: During 30 days
Results and safety
The study was stopped early (reason given: deficient inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
Related trials for Elderly People
Not yet recruiting
Comparative Effects of Exercises on Reactive Balance and Fall Risk in Community-Dwelling Older Adults
COMMUNITY-DWELLING OLDER ADULTS
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder
Recruiting
Plant-based Diet in Older People: What Consequences for Muscle Health?
Aging
RecruitingPhase 2
Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia
RecruitingObservational study
Predictive Model for Mortality in Older People With Critical Illness
Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Puissieux, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DETECT'CHUTE CLINIBED in people with Elderly People, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: deficient inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the positive predictive value of alerts (time frame: During 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2018.