Fall Detection and Prevention for Memory Care Through Real-time Artificial Intelligence Applied to Video
Primary Purpose
Alzheimer's Disease and Related Dementia, Fall Injury
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SafelyYou Fall Prevention System
Sponsored by
About this trial
This is an interventional supportive care trial for Alzheimer's Disease and Related Dementia
Eligibility Criteria
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
Sites / Locations
- SafelyYou
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
AI-enabled camera fall detection with Human-in-the-Loop (HIP) review
No camera detection
Outcomes
Primary Outcome Measures
Enrollment rate
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).
Fall rate due to sit to stand transition detection
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.
Fall rate due to gait change detection
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03685240
First Posted
September 19, 2018
Last Updated
May 5, 2022
Sponsor
SafelyYou
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT03685240
Brief Title
Fall Detection and Prevention for Memory Care Through Real-time Artificial Intelligence Applied to Video
Official Title
Fall Detection and Prevention for Memory Care Through Real-time Artificial Intelligence Applied to Video: A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 31, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SafelyYou
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease and Related Dementia, Fall Injury
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
460 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
AI-enabled camera fall detection with Human-in-the-Loop (HIP) review
Arm Title
Control
Arm Type
No Intervention
Arm Description
No camera detection
Intervention Type
Behavioral
Intervention Name(s)
SafelyYou Fall Prevention System
Intervention Description
Technology + Quality Assurance Services Provided by SafelyYou
Primary Outcome Measure Information:
Title
Enrollment rate
Description
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).
Time Frame
Data on enrollment will be recorded during recruitment in year 1 and assessed at the end of year 1
Title
Fall rate due to sit to stand transition detection
Description
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.
Time Frame
Data will be collected during year 1 and assessed at the end of year 1.
Title
Fall rate due to gait change detection
Description
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.
Time Frame
Data will be collected through year 1 and assessed at the end of year 1.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Glen Xiong, MD
Phone
415-579-3630
Ext
115
Email
gxiong@safely-you.com
Facility Information:
Facility Name
SafelyYou
City
San Francisco
State/Province
California
ZIP/Postal Code
94107
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Panganiban
Phone
415-579-3630
Email
jason@safely-you.com
First Name & Middle Initial & Last Name & Degree
Glen Xiong
Phone
4155793630
Ext
115
Email
gxiong@safely-you.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Fall Detection and Prevention for Memory Care Through Real-time Artificial Intelligence Applied to Video
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