- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03901976
ZeroFall - Reliability Testing of Optical Sensor to Detect Bed Exit for Patients in Hospital
November 18, 2020 updated by: Philips Healthcare
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wales
-
Bangor, Wales, United Kingdom, LL57 2PW
- Ysbyty Gwynedd
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Adult patients with risk of fall more than 24 hours on the ward
Exclusion Criteria:
Patients with predominantly palliative needs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Bed Exit Detection On
prevention of fall by a true bed exit detection
|
bed exit detection to avoid patients fall
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12-15 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christian P Subbe, MD, Ysbyty Gwynedd Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 25, 2019
Primary Completion (Actual)
November 5, 2020
Study Completion (Actual)
November 5, 2020
Study Registration Dates
First Submitted
March 28, 2019
First Submitted That Met QC Criteria
April 2, 2019
First Posted (Actual)
April 3, 2019
Study Record Updates
Last Update Posted (Actual)
November 20, 2020
Last Update Submitted That Met QC Criteria
November 18, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YGB-PH-CS-BD-2018-02-18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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