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

Fall From Bed Clinical Trial

Official title:

A Phase One Feasibility Study of the Sensable®Care System: Establishing a Communications System for Patient Fall Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03876496
• Other study ID #: Kaiser Downey CTA
• Status: Completed
• Phase: Early Phase 1
• Start date: September 24, 2017
• Est. completion date: December 7, 2017

Study information

• Verified date: March 2019
• Source: MedicusTek USA Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: December 7, 2017
• Est. primary completion date: October 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fall From Bed

Intervention

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.

Locations

Country	Name	City	State
United States	Downey Medical Center	Downey	California

Sponsors (2)

Lead Sponsor	Collaborator
MedicusTek USA Corporation	Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of Nursing Staff Who Want to Use the System Following the Trial	Acceptance of SensableCare System after Trial Period	focus group at week 8 within the 13 week study period
Primary	% of Nursing Staff Who Want to Use the System Following the Trial	Acceptance of SensableCare System after Trial Period	focus group at week 12 within the 13 week study period
Secondary	Rate of Bed Falls Decreased Over Study Period	Whether bed falls had decreased over the study period compared to before the start of the trial	through the 13 week study period