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Testing the Effectiveness of a Falls Prevention System

NCT03678402 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 521

Last updated 2024-07-12

Study results available
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Summary

The purpose of this single arm intervention study is to determine if the fall rate (as measured by falls per 1000 patient days) for patients designated "high fall risk" decreases with the use of the PUP™ \[Patient is UP Falls Prevention System\] when compared to the historical falls rate data for the prior 12 months from those same nursing units within the OSUWM Brain \& Spine Hospital.

Conditions

  • High Risk for Falling

Interventions

DEVICE

PUP™ sock

The Palarum Fall Prevention System that includes the PUP™ (Patient is Up) System, is made upon of seven tangible elements: an inpatient room Android tablet (IRT), a nurse station Android monitor (HUC), a local server (PLS), a cloud server (PCS), a Bluetooth Low Energy beacon(s), an Android smart watch, and an e-textile sock connected sensor transmitter (PUP™ sock). The PUP™ sock monitors and transmits pressure, force, acceleration and motion data.

Sponsors & Collaborators

  • Tammy Moore

    lead OTHER

Principal Investigators

  • Tammy Moore, RN, PHD · Ohio State University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-24
Primary Completion
2020-06-30
Completion
2020-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03678402 on ClinicalTrials.gov