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Sensable®Care System: Establishing a Communications System for Patient Fall Reduction

NCT03876496 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2019-03-15

No results posted yet for this study

Summary

The purpose of this study is to test the effectiveness, safety and side effects of Sensable®Care System for inpatients. The Sensable®Care System uses pressure sensors and computer software to sense how patients are positioned on the bed in order to reduce bed falls. The Sensable®Care System Mattress has sensors embedded in them, which will be monitored by the nurses in your unit.

This study has three specific aims:

1. To assess the comfort of the system when used with hospitalized patients;
2. To observe how the system can be integrated into nurses' and hospital staff's regular workflow to help to modify and improve the system.
3. To analyze data from nursing response to alerts generated from hospitalized patients to improve alert system performance.

Conditions

  • Fall From Bed

Interventions

DEVICE

SensableCare System

The Sensable®Care Mattress has sensors embedded in it. Sensable®Care System is able to identify if the subject is stirring in bed, sitting up from the bed, attempting to leave the bed, or being out of the bed. If the subject is found to be in any of these four scenarios, four different types of alerts/notifications will warn clinicians: Stirring Notification, Sitting Up Notification, Bed Leaving Alert, Out of Bed Alert, will be generated by Sensable®Care System respectively. Once these four alerts/notifications are generated, designated attending nurses or caregivers equipped with a mobile app will receive audible, vibratory, and/or visual alerts from the Dashboard with subject's room number and type of alert displayed mobile app. Thus, interventions/assistance can be carried out presumably early. Harm to patient safety may be prevented.

Sponsors & Collaborators

  • Kaiser Permanente

    collaborator OTHER

  • MedicusTek USA Corporation

    lead INDUSTRY

Principal Investigators

  • Jerry Spicer · Kaiser Permanente

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-24
Primary Completion
2017-10-21
Completion
2017-12-07
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 NCT03876496 on ClinicalTrials.gov