Fall Detection and Prevention for Memory Care Through Real-time Artificial Intelligence Applied to Video

NCT ID: NCT03685240

Last Updated: 2022-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

460 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-31

Study Completion Date

2023-12-31

Brief Summary

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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

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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%.

Conditions

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Alzheimer's Disease and Related Dementia Fall Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Intervention

AI-enabled camera fall detection with Human-in-the-Loop (HIP) review

Group Type EXPERIMENTAL

SafelyYou Fall Prevention System

Intervention Type BEHAVIORAL

Technology + Quality Assurance Services Provided by SafelyYou

Control

No camera detection

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SafelyYou Fall Prevention System

Technology + Quality Assurance Services Provided by SafelyYou

Intervention Type BEHAVIORAL

Eligibility Criteria

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Exclusion Criteria

\- 18 years old or younger
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

SafelyYou

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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SafelyYou

San Francisco, California, United States

Site Status

Countries

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United States

Central Contacts

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Glen Xiong, MD

Role: CONTACT

415-579-3630 ext. 115

Facility Contacts

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Jason Panganiban

Role: primary

415-579-3630

Glen Xiong

Role: backup

4155793630 ext. 115

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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SY-NIA-GX001

Identifier Type: -

Identifier Source: org_study_id

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