NCT04478149

Brief Summary

This study tests novel technology using computer vision and remote clinical review to reduce falls for residents with dementia in assisted living communities.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2023

Shorter than P25 for phase_2

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2020

Completed
3.3 years until next milestone

Study Start

First participant enrolled

October 31, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
2 months 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

Same day

First QC Date

July 15, 2020

Last Update Submit

May 5, 2022

Conditions

Dementia

Outcome Measures

Primary Outcomes (3)

  • Opt-in rate

    participants enrolling

    through study completion, an average of 1 year

  • Number of falls

    fall incidents

    through study completion, an average of 1 year

  • Number of ER visits

    fall incidents requiring emergency transportation

    through study completion, an average of 1 year

Study Arms (2)

Active Cameras

EXPERIMENTAL

active cameras in the room

Device: SafelyYou

Inactive Cameras

SHAM COMPARATOR

camera in the room, not activated

Other: Control

Interventions

SafelyYouDEVICE

technology to detect and prevent falls

Active Cameras
ControlOTHER

technology present but not activated

Inactive Cameras

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Living in a participating assisted living facility and suffering from dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Waitlist control
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2020

First Posted

July 20, 2020

Study Start

October 31, 2023

Primary Completion

October 31, 2023

Study Completion

December 31, 2023

Last Updated

May 9, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share