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

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Recruiting
CT.gov ID
NCT05875038
Collaborator
Hôpital Les Bateliers, CHU de Lille (Other), Hôpital cardiologique, CHU de Lille (Other), Hôpital Saint Philibert, GHICL (Other), Hôpital Côte de Nacre, CHU de Caen (Other), Hopital Charles Nicolle (Other), Hôpital Bois Guillaume, CHU de Rouen (Other), Centre Hospitalier de Saint-Quentin (Other), Centre Hospitalier de Beauvais (Other), Centre Hospitalier de Valenciennes (Other)
395
1
2
20.6
19.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: video system
  • Other: Tele-alarm
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
395 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Superiority of Intelligent Video Surveillance + Telealarm Over Telealarm Alone in Elderly People at Risk of Falling
Actual Study Start Date :
May 16, 2023
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Feb 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Occurrence of at least one unscheduled rehospitalization [90 days]

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

Secondary Outcome Measures

  1. number of days during unscheduled hospitalization [90 days]

    number of days during unscheduled hospitalization

  2. Number of days in emergency [90 days]

    Number of days in emergency within the first 90 days following the return home

Eligibility Criteria

Criteria

Ages Eligible for Study:
75 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Amiens Picardie Amiens Picardie France 80054

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT05875038
Other Study ID Numbers:
  • PI2019_843_0062
First Posted:
May 25, 2023
Last Update Posted:
May 25, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire, Amiens

Study Results

No Results Posted as of May 25, 2023