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

NCT ID: NCT03876496

Last Updated: 2019-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-24
• Study Completion Date: 2017-12-07

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

SensableCareCare System

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 the unit.

Group Type: EXPERIMENTAL

SensableCare System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

MedicusTek

Eligibility Criteria

Inclusion Criteria

• Gender: male or female
• Age: 18 years and older
• Racial and ethnic origin: all ethnic groups
• Hospital status: admitted in-patient or a patient under observation
• Expected hospital length of stay: minimum of 23 hours
• Willingness to participate in the study
• Moderate to High fall risk scoring a 2 or greater on the Mobility or Mental/LOC/Awareness status sections of the Hester Davis Fall Risk Assessment.

Exclusion Criteria

• Declined to participate
• Patients less than 18 years old
• Patients who have been identified as a low fall risk or moderate fall risk with score less than 2 on the Mobility or Mental/ LOC/Awareness status sections of the Hester Davis Fall Risk Assessment
• Women who are documented as pregnant during the study period
• Patients who are medically unstable; as per the discretion of the primary nurse
• Patients who are actively in the dying process, at the discretion of the primary nurse

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: collaborator

MedicusTek USA Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jerry Spicer

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

Downey Medical Center

Downey, California, United States

Countries

United States

Other Identifiers

Kaiser Downey CTA

Identifier Type: -

Identifier Source: org_study_id