ZeroFall - Reliability Testing of Optical Sensor to Detect Bed Exit for Patients in Hospital

Sponsor

Philips Healthcare (Industry)

Overall Status

Terminated

CT.gov ID

NCT03901976

Collaborator

(none)

Enrollment

Location

Arm

19.4

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Falls are one of the most common NHS adverse events. With an increasing number of frail elderly patients being admitted this risk is likely to increase. In order to be able to assist patients with bed exit in a timely manner monitoring might be of help. In ZeroFall we will test the reliability of monitoring devices to notify care givers if a patient is attempting to exit the bed.

Condition or Disease	Intervention/Treatment	Phase
Delirium of Mixed Origin	Device: bed exit detection	N/A

Detailed Description

In ZeroFall we intend to observe patients on risk of fall with two different devices during their hospital stay: The information from a no-touch optical sensing device that analyses movement and an under the mattress sensor that has already been used in a previous study at Bangor. Both are compatible with an existing monitoring system by Philips Healthcare and CE marked.

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

Intervention Model Description:

The study has several distinct phases: Silent Phase: The devices run in the background, activity is blinded for clinicians, settings are optimized by the research team. Run-In Phase: Bed exit notifications are turned on, notifications will be configurable for acceptability by clinical teams. Data extraction and data evaluation will be tested. Phase I: Data collection of bed exit data of sensors as well as data related to falls Phase II: Data collection of bed exit data with optimization of predictive algorithms Phase III: Data collection for validation using predictive data for early notificationThe study has several distinct phases:Silent Phase: The devices run in the background, activity is blinded for clinicians, settings are optimized by the research team. Run-In Phase: Bed exit notifications are turned on, notifications will be configurable for acceptability by clinical teams. Data extraction and data evaluation will be tested. Phase I: Data collection of bed exit data of sensors as well as data related to falls Phase II: Data collection of bed exit data with optimization of predictive algorithms Phase III: Data collection for validation using predictive data for early notification

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

ZeroFall - Reliability Testing of Optical Sensor to Detect Bed Exit for Patients in Hospital

Actual Study Start Date :

Mar 25, 2019

Actual Primary Completion Date :

Nov 5, 2020

Actual Study Completion Date :

Nov 5, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Bed Exit Detection On prevention of fall by a true bed exit detection	Device: bed exit detection bed exit detection to avoid patients fall

Arm

Intervention/Treatment

Other: Bed Exit Detection On

prevention of fall by a true bed exit detection

Device: bed exit detection

bed exit detection to avoid patients fall

Outcome Measures

Primary Outcome Measures

Number of true bed exit detections vs number of false bed exit detections [12-15 months]
A reference device and two observers will classify if a bed exit was true

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult patients with risk of fall more than 24 hours on the ward

Exclusion Criteria:

Patients with predominantly palliative needs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ysbyty Gwynedd	Bangor	Wales	United Kingdom	LL57 2PW

Sponsors and Collaborators

Philips Healthcare

Investigators

Principal Investigator: Christian P Subbe, MD, Ysbyty Gwynedd Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Philips Healthcare

ClinicalTrials.gov Identifier:

NCT03901976

Other Study ID Numbers:

YGB-PH-CS-BD-2018-02-18

First Posted:

Apr 3, 2019

Last Update Posted:

Nov 20, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Delirium

Study Results

No Results Posted as of Nov 20, 2020