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NoDelayFall: Time Spent on Floor After Falls of Frailty People Overnight

Sponsor
Centre Hospitalier Annecy Genevois (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03116386
Collaborator
(none)
0
Enrollment
1
Location
3
Arms
27.3
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: run-in period
  • Device: Control period
  • Device: Etolya-F ® devices
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
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)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)
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
Reduced Time on Floor After Falls at Night of People Living in Long Term Care Facilities - NoDelayFall Study
Actual Study Start Date :
Jan 20, 2017
Anticipated Primary Completion Date :
May 1, 2018
Anticipated Study Completion Date :
May 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: run-in period

In order to improve the precision of data, the run-in period is dedicated to sensitize the caregivers about the importance of reporting all the falls occurring during the night tracking in each resident's file, all informations about the estimate length of time spent on floor after a fall occurring during the night and also reporting every other events occuring at night as wandering. All the beds will progressively equipped with the Etolya-F ® devices but the Etolya-F ® ddevices will stay off.

Other: run-in period
observational time i.e. baseline situation
Sham Comparator: control period

We expect 30 falls will occurr at night during this 6 months period. Etolya-F ® devices will be installed on the bed of all participant residents but with limited fonctionnalities i.e. only the length of absence in the bed will be recorded (difference between time of detection of the beginning of absence in the bed and time where the resident will be found by the caregivers out of his bed).

Device: Control period
neither activation of any lighting environment when the resident gets up from his bed nor alert if the resident did not return to bed after 15 minutes Etolya-F ® devices will only permit detection and recording of the moment of the elderlly will leave his/her bed and recording of the moment the elderly will be found by caregivers
Experimental: Etolya-F ® devices

We also expect 30 falls will occur at night during this 6-month period. Etolya-F ® devices will be used with all their functionalities i.e. permit detection of absence in the bed, activation of a lighting environment when the resident gets up from his bed, transmission of alert to caregivers through the centralized system of sick call if the resident do not return to bed after 15 minutes and recording the time when caregivers will find the resident out of bed, distinguishing between a fall and a night wandering in the room or corridors without a fall

Device: Etolya-F ® devices
Etolya-F ® devices will permit detection of absence in the bed, activation of a lighting environment when the resident gets up from his bed, transmission of alert to caregivers through the centralized system of sick call if the resident do not return to bed after 15 minutes and recording the time when caregivers will find the resident out of bed, distinguishing between a fall and a night wandering in the room or corridors without a fall

Outcome Measures

Primary Outcome Measures

  1. Time for caregivers to find a resident who falls at night, before and after use of the Etolya-F® device [2 periods of 6 months]

    Delay elapsing between the moment a resident has left his/her bed and the time he/she was found by caregivers, on floor after a fall at night

Secondary Outcome Measures

  1. Diagnostic performance of the Etolya-F® device in the detection of night falls [2 periods of 6 months]

    sensitivity and specificity of Etolya-F®

  2. Traumatic consequences of falls [2 periods of 6 months]

    Number of night falls resulting in hospitalization, fracture (s) or wound (s) requiring suture (s) or death

Other Outcome Measures

  1. Number of night falls [2 periods of 6 months]

    Number of actual falls occurring at night during each of the two study periods

  2. Number of night wandering [2 periods of 6 months]

    Number of actual wandering occurring at night during each of the two study periods

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Résidence St François CH ANNECY-GENEVOIS Annecy France 74000

Sponsors and Collaborators

  • Centre Hospitalier Annecy Genevois

Investigators

  • Study Director: Dr Matthieu DEBRAY, MD, CH Annecy Genevois
  • Principal Investigator: Dr Nathalie RUEL, MD, CH Annecy Genevois

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Centre Hospitalier Annecy Genevois
ClinicalTrials.gov Identifier:
NCT03116386
Other Study ID Numbers:
  • 2016-A01799-42
First Posted:
Apr 17, 2017
Last Update Posted:
Apr 10, 2018
Last Verified:
Apr 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cognition Disorders

Study Results

No Results Posted as of Apr 10, 2018