NCT05964972

Brief Summary

Impact of an automatic alert device on the occurrence of nocturnal falls in nursing home residents Measurement of the number of nocturnal falls between 8 p.m. and 8 a.m. per registered resident in the 6 months preceding use of the device compared with the number of nocturnal falls in the 6 months after installation of the device.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 17, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 28, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

July 25, 2025

Status Verified

July 1, 2025

Enrollment Period

1.6 years

First QC Date

July 20, 2023

Last Update Submit

July 22, 2025

Conditions

Fall Patients

Outcome Measures

Primary Outcomes (1)

  • number of falls

    Measurement of the number of nocturnal falls between 8 p.m. and 8 a.m. per registered resident in the 6 months preceding use of the device compared with the number of nocturnal falls in the 6 months after installation of the device.

    6 month preceding and 6 month after

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Fallers

You may qualify if:

  • Resident of the elderly nursing home (EHPAD LES ORCHIDEES).
  • Repeated nocturnal falls (more than 2 falls at night between 8 p.m. and 8 a.m.) during the last 12 months.
  • Consent of the resident or his legal representative.
  • Signature of informed consent
  • French-speaking resident.

You may not qualify if:

  • Refusal to participate in the study.
  • Resident exclusive day faller.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ehpad Les Orchidees

Cagny, France

Location

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2023

First Posted

July 28, 2023

Study Start

May 17, 2022

Primary Completion

December 30, 2023

Study Completion

December 30, 2024

Last Updated

July 25, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)