Clinical trial NCT05457166: Use of the KASPARD System for Fall Prevention in Nursing Homes
Official title: Interest in Using the KASPARD System for the Prevention of Falls in Nursing Homes (EHPAD, for Its French Acronym)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Accidental Falls
Nursing Homes
Keywords: Elderly person
EHPAD
Fall
Prevention
Detection system
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Falls are a frequent cause of admission to nursing homes \[2\]. It is also the most frequently reported adverse event in these institutions.

The prevention of falls in EHPAD must mobilise several levers of action and involve all staff. It must be included in the establishment's project in the same way as the policy on the proper use of restraints \[21\].

Home automation and new technologies can contribute to the prevention of falls and their consequences. Most of the existing solutions on the market are either fall detection solutions based on a watch or pendant or rise detection solutions based on a sub-mattress or floor mat. All of these solutions work with a contact and often require a daily set-up or check by the care teams. But the real challenge today for new technologies is to prevent falls in the elderly, by directly addressing the risk factors.

KASPARD is a non-contact (remote sensors) and non-intrusive (no video image, it uses point cloud technology) solution for detecting falls, excessive wandering and nocturnal activities in a nursing home. The information is transmitted securely via the wifi network to a mobile phone (or TSI/DECT) and to a computer. The KASPARD solution, which is already on the market (non-medical CE marking), is used in several EHPADs in Belgium and France. It is not a medical device. To date, it has a sensitivity and specificity of over 90% (manufacturer's unpublished data).

We wish to verify the effectiveness of the KASPARD technology for the prevention of falls in EHPAD, suggested for the moment by an observational study, with the help of a multi-centre clinical study


Eligibility criteria: Inclusion Criteria:

* Male and/or female resident of an EHPAD
* Person aged ≥ 65 years
* Elderly person at high risk of falling (fell at least 1 time in the 6 months prior to inclusion)
* Resident or his/her legal representative who has given free, written, informed consent to participate in the trial
* Socially insured resident
* Resident willing to comply with all study procedures and duration. The questionnaires used will be validated questionnaires for the target population (QoL-AD questionnaire for residents and their carers).

Exclusion Criteria:

* Refusal to participate in the study
* Elderly resident who has a fall and for whom the use of a restraint is deemed essential by the coordinating doctor of the EHPAD
* Persons under legal protection are not excluded.

Primary outcomes:
measure: the number of falls observed over a period of 100 nights with KASPARD
timeFrame: 100 nights
Secondary outcomes:
measure: The number of night shift interventions
timeFrame: 100 nights with the device on versus 100 nights with the device off
measure: The number of nights without restraint
timeFrame: 100 nights with the device on versus 100 nights with the device off
measure: The time taken to intervene after a fall
timeFrame: 100 nights with the device on versus 100 nights with the device off
measure: Fear of falling assessed by the FES scale
timeFrame: 100 nights with the device on versus 100 nights with the device off
measure: Quality of life questionnaire
timeFrame: 100 nights with the device on versus 100 nights with the device off
measure: Resident satisfaction
timeFrame: activation period of 100 nights
measure: Night and day staff satisfaction
timeFrame: activation period of 100 nights
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: François Puisieux, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: