Completed

NCT Number: NCT03876496

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

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.

Completed

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Key information

Conditions

Fall From Bed

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Downey Medical Center

Downey, California, 90242, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SensableCare System

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.

Other names: MedicusTek

Primary outcomes

% of Nursing Staff Who Want to Use the System Following the Trial

Time frame: 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

Time frame: focus group at week 12 within the 13 week study period

Acceptance of SensableCare System after Trial Period

Secondary outcomes

Rate of Bed Falls Decreased Over Study Period

Time frame: through the 13 week study period

Whether bed falls had decreased over the study period compared to before the start of the trial

Sponsors and collaborators

Lead sponsor

MedicusTek USA Corporation

Industry

Collaborators

Kaiser Permanente

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Mar 15, 2019
Registry last updated: Mar 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.