A Comprehensive Fall Prevention System for Memory Care: Final Feasibility and Randomized Controlled Study

Phase 2

• Conditions: Dementia
• Interventions: Device: SafelyYou; Other: Control

• Registration Number: NCT04478149
• Lead Sponsor: SafelyYou

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-15
• Study First Submitted QC: 2020-07-17
• Study First Posted: 2020-07-20
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-09
• Study Start: 2023-10-31
• Primary Completion: 2023-10-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active Cameras	SafelyYou	active cameras in the room
Inactive Cameras	Control	camera in the room, not activated

Primary Outcome Measures

Name	Time	Method
Number of falls	through study completion, an average of 1 year	fall incidents
Opt-in rate	through study completion, an average of 1 year	participants enrolling
Number of ER visits	through study completion, an average of 1 year	fall incidents requiring emergency transportation