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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04478149
• Other study ID #: 241755
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 31, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2022
• Source: SafelyYou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Dementia

Intervention

Device:
• SafelyYou
technology to detect and prevent falls

Other:
• Control
technology present but not activated

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SafelyYou

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opt-in rate	participants enrolling	through study completion, an average of 1 year
Primary	Number of falls	fall incidents	through study completion, an average of 1 year
Primary	Number of ER visits	fall incidents requiring emergency transportation	through study completion, an average of 1 year