Clinical trial NCT03116386: Time Spent on Floor After Falls of Frailty People Overnight
Official title: Reduced Time on Floor After Falls at Night of People Living in Long Term Care Facilities - NoDelayFall Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dependence
Fall From Bed
Fall Injury
Fall in Nursing Home
Cognition Disorders
Lead sponsor: Centre Hospitalier Annecy Genevois
Sponsor class: OTHER
First posted: 2017-04-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Run-in period then 6 months control period and then 6 months experimental period with activation of all the functions of Etolya-F® (the device used in the study)
Primary purpose: DEVICE_FEASIBILITY

Brief summary: In the context of reduce staff for supervision of dependent elderly, automated risk alert systems could have a positive impact on the organization of night care by better targeting monitoring. Residents' sleep could be less affected with use of automatic alert system than by systematic monitoring visits. One study shows an improvement in the humor of residents after the use of such a system.

The hypothesis of the study is that the use of a bed-raising detection system linked with the activation of a lighting environment and a caregivers alert system (Etolya-F® gerontechnology device, Anaxi Technology Company) would reduce intervention time in this population, thus limiting the time spent on floor and its physical and psychological consequences.

Detailed description: In France in 2011, more than 575000 elderly lived in long term care facilities. Most of them had comorbidities.

The most frequent reason for admitting in long term care facilities is the worsening of health status of elderly, often triggered by a fall. Elderly living in long term care facilities have frequently several comorbidities; the first ones are Alzheimer and related diseases. The proportion of such very dependent institutionalized people has risen for the last recent years and they represent a population at very high risk of falling. In an epidemiological analysis of more than 70,000 falls from residents of Bavarian nursing homes, the prevalence of fall was estimated at 1.49 falls for women and 2.18 for men. Those results didn't take into account the fact that people could fall more than once a day. In Alzheimer people (or people with related diseases) who lived in long term care facilities, the incidence of falls was even highest with 2.7 falls per resident per year.

The consequences of falls are not only physical injuries (wounds, fractures); they are frequently associated with psychological repercussions as loss of self-confidence, fear of new falls, reduction of abilities of moving which lead into declining of daily activities and loss of autonomy.

The incapacity of getting up alone is reported by more than a third of patients who have fallen, even if the fall is not complicated by a fracture. The length of time people stay on floor is directly link to the ability of the elderly person to give an alarm and to the presence or not of someone else to help him/her to get up. Patients who live in long term care facilities have limited functional capabilities not compatible with an operational use of active alarm systems.

In long term care facilities, 30-40% of falls occur between 8pm and 8am. Falls occurring at night seem to be associated with more severe injuries. Staff are less numerous at night with only 3 to 4 caregivers for 100 people.

To the best of the knowledge of the investigators, delay intervention time after a fall occurring at night has never been studied. Based on the investigators' experience, elderly people can only be discovered and helped when caregivers find them on floor on the occasion of a planned surveillance visit. These visits are carried out every 2 to 4 hours at night.

Automated alarms are used to alert staff to situations where there is a high risk of falling: an attempt to lift an armchair from a person who cannot stand or to detect the night-time rise of a high-risk people with the use of various sensors (pressure sensors connected to the mattress or environmental sensors).

In the context of staff reduced at night for the supervision of dependent elderly, automated risk alert systems could also have a positive impact on the organization of night care by better targeting monitoring. Residents' sleep could be less affected with use of automatic alert system than by systematic monitoring visits. One study shows an improvement in the humor of residents after the use of such a system.

The hypothesis of the study is that the use of a bed-raising detection system linked with the activation of a lighting environment and a personnel alert system (Etolya-F® gerontechnology device, Anaxi Technology Company) would reduce intervention time in this population, thus limiting the time spent on floor and its physical and psychological consequences.

Eligibility criteria: Inclusion Criteria:

* elderly people who are resident in long term care facilities
* non opposed to participate to the study or whose his/her legal representative is not opposed to the participation of the resident to the study

Exclusion Criteria:

* the resident's bed can not be equipped with the ETOLYA-F® device for any reason

Primary outcomes:
measure: Time for caregivers to find a resident who falls at night, before and after use of the Etolya-F® device
timeFrame: 2 periods of 6 months
Secondary outcomes:
measure: Diagnostic performance of the Etolya-F® device in the detection of night falls
timeFrame: 2 periods of 6 months
measure: Traumatic consequences of falls
timeFrame: 2 periods of 6 months
Other outcomes:
measure: Number of night falls
timeFrame: 2 periods of 6 months
measure: Number of night wandering
timeFrame: 2 periods of 6 months
Locations:
city: Annecy
country: France
facility: Résidence St François CH ANNECY-GENEVOIS
Study officials:
affiliation: CH Annecy Genevois
name: Dr Matthieu DEBRAY, MD
role: STUDY_DIRECTOR
affiliation: CH Annecy Genevois
name: Dr Nathalie RUEL, MD
role: PRINCIPAL_INVESTIGATOR
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