Accidental Falls, Nursing Homes
Conditions
Keywords
Elderly person, EHPAD, Fall, Prevention, Detection system
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 To date, it has a sensitivity and specificity of over 90% (manufacturer's unpublished data).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
Interventions
DEVICEKASPARD system for fall prevention in nursing homes
All subjects will be monitored for 2 periods of 100 nights each. Recordings will be made continuously at night for the duration of the study Period 0: set-up, adjustment, recording (without alarm); This is a preparatory phase which is part of the usual use of the device. Duration: 10 days Before period: The BEFORE period runs for 100 nights during which the device alarm is not activated, but the device records events. After period: The AFTER period is 100 nights during which the device alarm is activated: Monitoring with recording + alarm activated (usual care + action if alarm is triggered)
Sponsors
University Hospital, Lille
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the number of falls observed over a period of 100 nights with KASPARD | 100 nights | To show that the KASPARD system reduces the number of falls observed over a period of 100 nights with the device activated compared to a period of 100 nights with the device deactivated, in elderly people aged over 65 years residing in EPAD and at high risk of falling. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of night shift interventions | 100 nights with the device on versus 100 nights with the device off | — |
| The number of nights without restraint | 100 nights with the device on versus 100 nights with the device off | — |
| The time taken to intervene after a fall | 100 nights with the device on versus 100 nights with the device off | Time between the occurrence of the fall and the arrival of staff at the patient's bedside |
| Fear of falling assessed by the FES scale | 100 nights with the device on versus 100 nights with the device off | Fear of falling reported by residents at the end of each period: last day of period 1 and last day of period 2 |
| Quality of life questionnaire | 100 nights with the device on versus 100 nights with the device off | Quality of life questionnaire reported by the patient and once at the end of each period: last day of period 1 and last day of period 2 |
| Resident satisfaction | activation period of 100 nights | Resident satisfaction will be assessed by a satisfaction questionnaire |
| Night and day staff satisfaction | activation period of 100 nights | Staff satisfaction will be assessed by a satisfaction questionnaire evaluating organisational aspects, disturbance of walking patients, interest in the reports provided by the system |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORFrançois Puisieux, MD,PhD
University Hospital, Lille
Outcome results
None listed