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

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.

Study Overview

• Status: Recruiting
• Conditions: Fall; Home; Intelligent Video Surveillance; Frail Elderly Person
• Intervention / Treatment: Other: video system; Other: Tele-alarm

• Study Type: Interventional
• Enrollment (Estimated): 395
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guillaume Deschasse, MD; Phone Number: 03 22 08 80 00; Email: Deschasse.Guillaume@chu-amiens.fr

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80054
      • Recruiting
      • CHU Amiens Picardie
      • Contact: Guillaume DESCHASSE, Dr; Phone Number: 03 22 45 57 20; Email: deschasse.guillaume@chu-amiens.fr
      • Principal Investigator: Francois PUISIEUX, MD
      • Principal Investigator: Jean-Baptiste BEUSCART, MD
      • Principal Investigator: Fabien VISADE, MD
      • Principal Investigator: Gilles LOGGIA, MD
      • Principal Investigator: Fréderic ROCA, MD
      • Principal Investigator: Emmanuelle GREBOVAL, MD
      • Principal Investigator: Jadwiga ATTIER, MD
      • Principal Investigator: Yoan LEFRESNE, MD
      • Principal Investigator: Eléonore CANTEGRIT, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intelligent Video Monitoring + Tele-alarm	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.; Other: Tele-alarm; Tele-alarm
Active Comparator: Tele-alarm only	Other: Tele-alarm; Tele-alarm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of days during unscheduled hospitalization	number of days during unscheduled hospitalization	90 days
Number of days in emergency	Number of days in emergency within the first 90 days following the return home	90 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Fall; home; teleassistance; intelligent video surveillance; frail elderly person
• Other Study ID Numbers: PI2019_843_0062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No