Superiority of Intelligent Video Surveillance + Telealarm Over Telealarm Alone in Elderly People at Risk of Falling

Fall Clinical Trial

— VIGIALARM  

Official title:

Superiority of Intelligent Video Surveillance + Telealarm Over Telealarm Alone in Elderly People at Risk of Falling

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05875038
• Other study ID #: PI2019_843_0062
• Status: Recruiting
• Phase: N/A
• Start date: May 16, 2023
• Est. completion date: February 2025

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Guillaume Deschasse, MD
• Phone: 03 22 08 80 00
• Email: Deschasse.Guillaume[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 395
• Est. completion date: February 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Fall
• Home

Intervention

Other:
• video system
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.
• Tele-alarm
Tele-alarm

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Picardie

Sponsors (10)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	Centre Hospitalier de Beauvais, Centre Hospitalier de Saint-Quentin, Centre Hospitalier de Valenciennes, Hôpital Bois Guillaume, CHU de Rouen, Hôpital cardiologique, CHU de Lille, Hopital Charles Nicolle, Hôpital Côte de Nacre, CHU de Caen, Hôpital Les Bateliers, CHU de Lille, Hôpital Saint Philibert, GHICL

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	number of days during unscheduled hospitalization	number of days during unscheduled hospitalization	90 days
Secondary	Number of days in emergency	Number of days in emergency within the first 90 days following the return home	90 days