Time Spent on Floor After Falls of Frailty People Overnight

NCT03116386 | Withdrawn

• 1 other identifier: 2016-A01799-42
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Dependence; Fall From Bed; Fall Injury; Fall in Nursing Home; Cognition Disorders

Outcome Measures

Primary Outcomes (1)

• Time for caregivers to find a resident who falls at night, before and after use of the Etolya-F® device

  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

  2 periods of 6 months

Secondary Outcomes (2)

• Diagnostic performance of the Etolya-F® device in the detection of night falls

  2 periods of 6 months

• Traumatic consequences of falls

  2 periods of 6 months

Other Outcomes (2)

• Number of night falls

  2 periods of 6 months

• Number of night wandering

  2 periods of 6 months

Study Arms (3)

run-in period

OTHER

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

control period

SHAM COMPARATOR

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

Etolya-F ® devices

EXPERIMENTAL

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

Interventions

run-in period OTHER

observational time i.e. baseline situation

run-in period

Control period DEVICE

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

control period

Etolya-F ® devices DEVICE

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

Etolya-F ® devices

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Annecy Genevois: lead

Study Sites (1)

Résidence St François CH ANNECY-GENEVOIS

Annecy, 74000, France

Location

Related Publications (14)

• Rapp K, Becker C, Cameron ID, Konig HH, Buchele G. Epidemiology of falls in residential aged care: analysis of more than 70,000 falls from residents of bavarian nursing homes. J Am Med Dir Assoc. 2012 Feb;13(2):187.e1-6. doi: 10.1016/j.jamda.2011.06.011. Epub 2011 Aug 4.

  PMID: 21816682 BACKGROUND

• Pellfolk T, Gustafsson T, Gustafson Y, Karlsson S. Risk factors for falls among residents with dementia living in group dwellings. Int Psychogeriatr. 2009 Feb;21(1):187-94. doi: 10.1017/S1041610208007837. Epub 2008 Oct 6.

  PMID: 18834557 BACKGROUND

• Jensen J, Lundin-Olsson L, Nyberg L, Gustafson Y. Falls among frail older people in residential care. Scand J Public Health. 2002;30(1):54-61.

  PMID: 11928835 BACKGROUND

• Vu MQ, Weintraub N, Rubenstein LZ. Falls in the nursing home: are they preventable? J Am Med Dir Assoc. 2006 Mar;7(3 Suppl):S53-8, 52. doi: 10.1016/j.jamda.2005.12.016.

  PMID: 16500282 BACKGROUND

• Lach HW, Parsons JL. Impact of fear of falling in long term care: an integrative review. J Am Med Dir Assoc. 2013 Aug;14(8):573-7. doi: 10.1016/j.jamda.2013.02.019. Epub 2013 Apr 16.

  PMID: 23602257 BACKGROUND

• Fleming J, Brayne C; Cambridge City over-75s Cohort (CC75C) study collaboration. Inability to get up after falling, subsequent time on floor, and summoning help: prospective cohort study in people over 90. BMJ. 2008 Nov 17;337:a2227. doi: 10.1136/bmj.a2227.

  PMID: 19015185 BACKGROUND

• Bergland A, Laake K. Concurrent and predictive validity of "getting up from lying on the floor". Aging Clin Exp Res. 2005 Jun;17(3):181-5. doi: 10.1007/BF03324594.

  PMID: 16110729 BACKGROUND

• Lester P, Haq M, Vadnerkar A, Feuerman M. Falls in the nursing home setting: does time matter? J Am Med Dir Assoc. 2008 Nov;9(9):684-6. doi: 10.1016/j.jamda.2008.06.007. Epub 2008 Sep 25.

  PMID: 18992702 BACKGROUND

• Pelissier C, Vohito M, Fort E, Sellier B, Agard JP, Fontana L, Charbotel B. Risk factors for work-related stress and subjective hardship in health-care staff in nursing homes for the elderly: A cross-sectional study. J Occup Health. 2015;57(3):285-96. doi: 10.1539/joh.14-0090-OA. Epub 2015 Apr 10.

  PMID: 25864937 BACKGROUND

• Capezuti E, Brush BL, Lane S, Rabinowitz HU, Secic M. Bed-exit alarm effectiveness. Arch Gerontol Geriatr. 2009 Jul-Aug;49(1):27-31. doi: 10.1016/j.archger.2008.04.007. Epub 2008 Jun 3.

  PMID: 18508138 BACKGROUND

• Banerjee S, Steenkeste F, Couturier P, Debray M, Franco A. Telesurveillance of elderly patients by use of passive infra-red sensors in a 'smart' room. J Telemed Telecare. 2003;9(1):23-9. doi: 10.1258/135763303321159657.

  PMID: 12641889 BACKGROUND

• Lipsitz LA, Tchalla AE, Iloputaife I, Gagnon M, Dole K, Su ZZ, Klickstein L. Evaluation of an Automated Falls Detection Device in Nursing Home Residents. J Am Geriatr Soc. 2016 Feb;64(2):365-8. doi: 10.1111/jgs.13708. Epub 2016 Jan 19.

  PMID: 26783046 BACKGROUND

• Tinetti ME, Williams CS. Falls, injuries due to falls, and the risk of admission to a nursing home. N Engl J Med. 1997 Oct 30;337(18):1279-84. doi: 10.1056/NEJM199710303371806.

  PMID: 9345078 BACKGROUND

• Parker MJ, Gillespie WJ, Gillespie LD. Effectiveness of hip protectors for preventing hip fractures in elderly people: systematic review. BMJ. 2006 Mar 11;332(7541):571-4. doi: 10.1136/bmj.38753.375324.7C. Epub 2006 Mar 2.

  PMID: 16513687 BACKGROUND

Related Links

• New technologies likely to improve gerontological practices and the daily life of elderly patients and their families

MeSH Terms

Conditions

Cognition Disorders

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders

Study Officials

• Dr Matthieu DEBRAY, MD

  CH Annecy Genevois

  STUDY DIRECTOR

• Dr Nathalie RUEL, MD

  CH Annecy Genevois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 17, 2017
• Study Start: January 20, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2019
• Last Updated: April 10, 2018

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)