Back to resultsA Comprehensive Fall Prevention System for Memory Care: Final Feasibility and Randomized Controlled Study
Primary Purpose
Dementia
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SafelyYou
Control
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia
Eligibility Criteria
Inclusion Criteria:
- Living in a participating assisted living facility and suffering from dementia
Exclusion Criteria:
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active Cameras
Inactive Cameras
Arm Description
active cameras in the room
camera in the room, not activated
Outcomes
Primary Outcome Measures
Opt-in rate
participants enrolling
Number of falls
fall incidents
Number of ER visits
fall incidents requiring emergency transportation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04478149
Brief Title
A Comprehensive Fall Prevention System for Memory Care: Final Feasibility and Randomized Controlled Study
Official Title
A Comprehensive Fall Prevention System for Memory Care: Final Feasibility and Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 31, 2023 (Anticipated)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SafelyYou
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Waitlist control
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Cameras
Arm Type
Experimental
Arm Description
active cameras in the room
Arm Title
Inactive Cameras
Arm Type
Sham Comparator
Arm Description
camera in the room, not activated
Intervention Type
Device
Intervention Name(s)
SafelyYou
Intervention Description
technology to detect and prevent falls
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
technology present but not activated
Primary Outcome Measure Information:
Title
Opt-in rate
Description
participants enrolling
Time Frame
through study completion, an average of 1 year
Title
Number of falls
Description
fall incidents
Time Frame
through study completion, an average of 1 year
Title
Number of ER visits
Description
fall incidents requiring emergency transportation
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Living in a participating assisted living facility and suffering from dementia
Exclusion Criteria:
-
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Comprehensive Fall Prevention System for Memory Care: Final Feasibility and Randomized Controlled Study
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