NCT05875038

Brief Summary

Maintaining the elderly at home and preventing them from falling are major public health issues. The vast majority of elderly people wish to remain at home. The fear of a fall with prolonged standing is a frequent reason for institutionalization. There are few procedures that have been shown to be effective in preventing falls and their complications. Prolonged standing on the floor is a major complication that can lead to multiple events, including death. Tele-alarms are widely used in France and in Europe, but their effectiveness in the event of a fall is poor and their use is restrictive (they require physical and mental capacities to activate). However, elderly people at risk of falling are often frail or dependent, suffering from cognitive disorders and sometimes polymorbid, which explains the large number of failures of tele-alarms. There are other alert systems, notably intelligent video surveillance systems such as the VA2CS. This is a video system placed in the home that analyzes the position of subjects in real time using algorithms based on artificial intelligence. The system works continuously without video capture and sends an alert with a photo if a person is lying down after a fall. The alert is confirmed after an operator has checked the photo capture on a dedicated platform. To date, it has a sensitivity and specificity of over 90% (manufacturer's data not published). Its performance is equivalent to other intelligent video surveillance systems published in the literature. This system is autonomous and does not rely on the abilities of the person at risk of falling. Intelligent video surveillance is an innovative technology which has not yet been evaluated in a geriatric care program, nor compared to a reference or analyzed from a quality of life or medico-economic perspective. The hypothesis of this study is that intelligent video surveillance allows an exhaustive and early detection of the fall with a faster alert enabling to avoid prolonged standing on the ground and its consequences compared to the tele-alarm alone.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
395

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress84%
May 2023Dec 2026

First Submitted

Initial submission to the registry

May 16, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

May 16, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

3.5 years

First QC Date

May 16, 2023

Last Update Submit

September 2, 2025

Conditions

Intelligent Video SurveillanceFallHomeFrail Elderly Person

Keywords

intelligent video surveillanceFallhomefrail elderly personteleassistance

Outcome Measures

Primary Outcomes (1)

  • Occurrence of at least one unscheduled rehospitalization

    Occurrence of at least one unscheduled rehospitalization within the first 90 days following the return home.

    90 days

Secondary Outcomes (2)

  • number of days during unscheduled hospitalization

    90 days

  • Number of days in emergency

    90 days

Study Arms (2)

Intelligent Video Monitoring + Tele-alarm

EXPERIMENTAL
Other: video systemOther: Tele-alarm

Tele-alarm only

ACTIVE COMPARATOR
Other: Tele-alarm

Interventions

video systemOTHER

The video surveillance system will analyze the position of subjects in real time using algorithms based on artificial intelligence. The system works continuously without video capture and sends an alert with a photo if a person is lying down after a fall. The alert is confirmed after an operator has checked the photo capture on a dedicated platform.

Intelligent Video Monitoring + Tele-alarm
Tele-alarmOTHER

Tele-alarm

Intelligent Video Monitoring + Tele-alarmTele-alarm only

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Person aged 75 years or more
  • hospitalized in an acute geriatric service or in a geriatric or multipurpose rehabilitation care service
  • If living alone: receiving at least one visit per day from a relative or professional
  • Recent history of fall and monopodal support \< 5 seconds
  • Able to give informed consent.
  • Return home considered complex by the patient or their relatives due to the risk of falling at home.

You may not qualify if:

  • Under legal protection
  • Not affiliated to a social security system
  • Confined to bed or chair

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

RECRUITING

Central Study Contacts

Guillaume Deschasse, MD

CONTACT

03 22 08 80 00Deschasse.Guillaume@chu-amiens.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2023

First Posted

May 25, 2023

Study Start

May 16, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 9, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)