NCT03685240

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
460

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
5.1 years until next milestone

Study Start

First participant enrolled

October 31, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

2 months

First QC Date

September 19, 2018

Last Update Submit

May 5, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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).

    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

    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

    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.

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: SafelyYou Fall Prevention System

Control

NO INTERVENTION

No camera detection

Interventions

Technology + Quality Assurance Services Provided by SafelyYou

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • \- 18 years old or younger

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SafelyYou

San Francisco, California, 94107, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2018

First Posted

September 26, 2018

Study Start

October 31, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

May 9, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations