Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03901976
Recruitment Status : Terminated (Not enough resources in place; COVID-19 pandemic impedes working on the project and travelling within the EU)
First Posted : April 3, 2019
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Philips Healthcare

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 Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 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 : March 25, 2019
Actual Primary Completion Date : November 5, 2020
Actual Study Completion Date : November 5, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Number of true bed exit detections vs number of false bed exit detections [ Time Frame: 12-15 months ]
    A reference device and two observers will classify if a bed exit was true



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients with predominantly palliative needs


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03901976


Locations
Layout table for location information
United Kingdom
Ysbyty Gwynedd
Bangor, Wales, United Kingdom, LL57 2PW
Sponsors and Collaborators
Philips Healthcare
Investigators
Layout table for investigator information
Principal Investigator: Christian P Subbe, MD Ysbyty Gwynedd Hospital
Layout table for additonal information
Responsible Party: Philips Healthcare
ClinicalTrials.gov Identifier: NCT03901976    
Other Study ID Numbers: YGB-PH-CS-BD-2018-02-18
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders