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

Sponsor

MedicusTek USA Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT03876496

Collaborator

Kaiser Permanente (Other)

Enrollment

Location

Arm

2.4

Actual Duration (Months)

29.2

Patients Per Site Per Month

Study Details

Study Description

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:

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

Condition or Disease	Intervention/Treatment	Phase
Fall From Bed	Device: SensableCare System	Early Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

71 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 24, 2017

Actual Primary Completion Date :

Oct 21, 2017

Actual Study Completion Date :

Dec 7, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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. Other Names: MedicusTek

Arm

Intervention/Treatment

Experimental: 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.

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.

Other Names:

MedicusTek

Outcome Measures

Primary Outcome Measures

% of Nursing Staff Who Want to Use the System Following the Trial [focus group at week 8 within the 13 week study period]
Acceptance of SensableCare System after Trial Period
% 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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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