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

May 5, 2022 updated by: SafelyYou
This study tests novel technology using computer vision and remote clinical review to reduce falls for residents with dementia in assisted living communities.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Cameras
active cameras in the room
Device: SafelyYou
technology to detect and prevent falls
Sham Comparator: Inactive Cameras
camera in the room, not activated
Other: Control
technology present but not activated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opt-in rate
Time Frame: through study completion, an average of 1 year
participants enrolling
through study completion, an average of 1 year
Number of falls
Time Frame: through study completion, an average of 1 year
fall incidents
through study completion, an average of 1 year
Number of ER visits
Time Frame: through study completion, an average of 1 year
fall incidents requiring emergency transportation
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SafelyYou

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 31, 2023

Primary Completion (Anticipated)

October 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

July 15, 2020

First Submitted That Met QC Criteria

July 17, 2020

First Posted (Actual)

July 20, 2020

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 5, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 241755

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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