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

MedicusTek

Status and phase: Completed; Early Phase 1

Conditions: Fall From Bed

Treatments: Device: SensableCare System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03876496

Kaiser Downey CTA

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 1 patient group

SensableCareCare System

Experimental group

Description:

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.

Treatment:

Device: SensableCare System