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

Early Phase 1

Completed

• Conditions: Fall From Bed
• Interventions: Device: SensableCare System

• Registration Number: NCT03876496
• Lead Sponsor: MedicusTek USA Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-24
• Primary Completion: 2017-10-21
• Study Completion: 2017-12-07
• Study First Submitted: 2018-08-22
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-13
• Last Update Submitted: 2019-03-13
• Study First Posted: 2019-03-15
• Last Update Posted: 2019-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SensableCareCare System	SensableCare 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.

Primary Outcome Measures

Name	Time	Method
% of Nursing Staff Who Want to Use the System Following the Trial	focus group at week 12 within the 13 week study period	Acceptance of SensableCare System after Trial Period

Secondary Outcome Measures

Name	Time	Method
Rate of Bed Falls Decreased Over Study Period	through the 13 week study period	Whether bed falls had decreased over the study period compared to before the start of the trial

Trial Locations

Locations (1)

Downey Medical Center; 🇺🇸 Downey, California, United States