- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03685240
Fall Detection and Prevention for Memory Care Through Real-time Artificial Intelligence Applied to Video
Fall Detection and Prevention for Memory Care Through Real-time Artificial Intelligence Applied to Video: A Randomized Control Trial
The purpose of the research is to study a new safety monitoring system developed by SafelyYou to help care for a loved one with dementia. The goal is to provide better support for unwitnessed falls.
The SafelyYou system is based on AI-enabled cameras which detect fall related events and upload video only when these events are detected. The addition of a Human in the Loop (HIL) will alert the facility staff when an event is detected by the system.
Study Overview
Status
Intervention / Treatment
Detailed Description
This process enables staff to know about falls without requiring residents wear a device and to see how falls occur for residents that cannot advocate for themselves while still protecting resident privacy by only uploading video when safety critical events are detected. Seeing how the resident went to the ground (1) prevents the need for emergency room visits when residents intentionally moved to the ground without risk and (2) allows the care team to determine what caused an event like a fall and what changes can be made to reduce risk.
PRELIMINARY EVIDENCE. The proposed study follows a series of pilots. In pilot 1, we showed the technical feasibility of detecting falls from video with 200 falls acted out by healthy subjects. In pilot 2, in a 40-resident facility, we demonstrated the acceptance of privacy-safety tradeoffs and showed a reduction of total facility falls by 80% by providing the system for 10 repeat fallers. In pilot 3, we addressed repeatability of fall reduction in a cohort of 87 residents with ADRD in 11 facilities of three partner networks. In pilot 4 (NIH SBIR Phase I), we demonstrated that falls can be detected reliably in real-time within the partner facilities. We detected 93% of the falls; reduced the time on the ground by 42%; showed that when video was available, the likelihood of EMS visit was reduced by 50%; and reduced total facility falls by 38%.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Glen Xiong, MD
- Phone Number: 115 415-579-3630
- Email: gxiong@safely-you.com
Study Locations
-
-
California
-
San Francisco, California, United States, 94107
- SafelyYou
-
Contact:
- Jason Panganiban
- Phone Number: 415-579-3630
- Email: jason@safely-you.com
-
Contact:
- Glen Xiong
- Phone Number: 115 4155793630
- Email: gxiong@safely-you.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
The study population includes residents of care facilities that are a high fall risk with a particular focus on care facilities with high populations of individuals with Alzheimer's disease and related dementias. There are no gender, race, ethnicity, language or literacy requirements for participation and all residents are eligible.
Inclusion criteria - Living at a participating skilled nursing facility or equivalent, CCRC,
Exclusion criteria
- 18 years old or younger
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention
AI-enabled camera fall detection with Human-in-the-Loop (HIP) review
|
Technology + Quality Assurance Services Provided by SafelyYou
|
NO_INTERVENTION: Control
No camera detection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Enrollment rate
Time Frame: Data on enrollment will be recorded during recruitment in year 1 and assessed at the end of year 1
|
Detection of falls will be performed with blurred video, hence with increased privacy.
Expected outcome will be the change in enrollment rate compared to previous feasibility studies (i.e.
impacted rate of positive responses to recruitment efforts within facilities).
|
Data on enrollment will be recorded during recruitment in year 1 and assessed at the end of year 1
|
Fall rate due to sit to stand transition detection
Time Frame: Data will be collected during year 1 and assessed at the end of year 1.
|
Care staff will be alerted as soon as the transition is detected (intervention of the front line staff).
This may produce an immediate reduction in falls due to this type of transition.
|
Data will be collected during year 1 and assessed at the end of year 1.
|
Fall rate due to gait change detection
Time Frame: Data will be collected through year 1 and assessed at the end of year 1.
|
As the system learns to may produce an immediate impact on the fall rate by intervention of the front-line staff when the change is detected.
|
Data will be collected through year 1 and assessed at the end of year 1.
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SY-NIA-GX001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fall Injury
-
University of AmsterdamCompletedDeprescribing | Fall | Fall Injury | Fall Patients | Accidental FallNetherlands
-
University of ArizonaVirginia Polytechnic Institute and State UniversityNot yet recruiting
-
Neuroscience Research AustraliaThe University of New South WalesCompleted
-
University of Illinois at Urbana-ChampaignUnknownFall Injury | Fall Prevention | Fall Safety
-
Dalarna UniversitySormland County Council, SwedenRecruiting
-
Duke-NUS Graduate Medical SchoolNot yet recruiting
-
Aalborg University HospitalCompleted
-
Isra UniversityUnknownPhysical Therapy | Fall Injury | Fall Patients | Geriatric Fall | Balance TraiingPakistan
-
Dalarna UniversitySormland County Council, SwedenCompletedFall Injury | Accidental Fall | Work-related Injury | Work AccidentSweden
-
Methodist Health SystemEnrolling by invitation
Clinical Trials on SafelyYou Fall Prevention System
-
Fooyin UniversityUnknown
-
New York UniversityCompleted
-
New York UniversityCompletedHealthy Aging | Accidental Fall | Injury PreventionUnited States
-
University of Colorado, DenverNational Institute on Aging (NIA); Apple Inc.Active, not recruiting
-
Ministry of Health, KuwaitRecruitingOsteo Arthritis Knee | Fall | Total Knee ReplacementKuwait
-
Helse Møre og Romsdal HFNorwegian University of Science and Technology; Sykehuset Innlandet HFCompletedAccidental Falls | Hospitalized PatientsNorway
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and Development; Stichting...Terminated
-
Massachusetts General HospitalCrico; Inspiren Inc; RGI Informatics LLCNot yet recruitingFalls and Falls With Injury
-
Gérond'ifCompleted
-
Brigham and Women's HospitalBest Buy Health, IncCompleted