Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05875038
Other study ID # PI2019_843_0062
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04612842 - Engaging Older Adults in Fall Prevention Using Motivational Interviewing (MI) N/A
Enrolling by invitation NCT03297632 - Improving Muscle Strength, Mass and Physical Function in Older Adults N/A
Completed NCT06063187 - Technology-based Fall Risk Assessments for Older Adults in Low-income Settings
Withdrawn NCT04470895 - Impact of Drugs on the Risk of Falls in the Fracture Department of the Paris Saint-Joseph Hospital Group
Recruiting NCT05940779 - Relationship Between the Risk of Falls and Frailty, and the Effect of a Physical Exercise Program on These Conditions in the Elderly: a Randomized Crossover Clinical Trial. N/A
Not yet recruiting NCT05940636 - A Novel Combined Neuromodulation Therapy to Enhance Balance and Neuroplasticity N/A
Not yet recruiting NCT05991037 - Relation Between Psychoactive Drugs Overdosage and Severity of Falls in Elderly People N/A
Completed NCT03566719 - Effect of an Exercise Program on Risk of Fall in a Community Dwelling Older Adults N/A
Not yet recruiting NCT05702801 - Vibratory Stimulation to Improve Balance Recovery N/A
Not yet recruiting NCT04439097 - Effects of Multicomponent Physical Exercise Program and Mediterranean Diet in Alzheimer's Disease N/A
Recruiting NCT04108741 - Augmented Reality Treadmill Training in Patients With Parkinson's Disease N/A
Completed NCT04760392 - Goal-directed Mobilization of Medical Inpatients N/A
Not yet recruiting NCT03680014 - Remote Monitoring and Analysis of Gait and Falls Within an Elderly Population
Recruiting NCT04851405 - Implementing an Evidence-based Exercise Program to Reduce Falls in Community-dwelling Older Adults (Otago) N/A
Completed NCT05090774 - Integrating Fall Prevention Balance Exercises Into a Program for Older Adults With Peripheral Artery Disease (PAD): A Mixed Methods Feasibility Study N/A
Completed NCT04334746 - The Discriminative Ability of the Four Balance Measures for Fall History
Completed NCT03341728 - The Sensorimotor Locus of Balance Control in Elderly Gait N/A
Completed NCT05290571 - Modified Otago Exercise Program on Balance Performance N/A
Completed NCT04622657 - Validity Reliability of The Dubousset Functional Test in Parkinson Disease N/A
Completed NCT05863143 - Intervention on Reducing Risk of Falls Among Community Dwelling Older Adults in Selangor N/A