Back to resultsZeroFall - Reliability Testing of Optical Sensor to Detect Bed Exit for Patients in Hospital
Primary Purpose
Delirium of Mixed Origin
Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
bed exit detection
Sponsored by
About this trial
This is an interventional prevention trial for Delirium of Mixed Origin
Eligibility Criteria
Inclusion Criteria:
Adult patients with risk of fall more than 24 hours on the ward
Exclusion Criteria:
Patients with predominantly palliative needs
Sites / Locations
- Ysbyty Gwynedd
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Bed Exit Detection On
Arm Description
prevention of fall by a true bed exit detection
Outcomes
Primary Outcome Measures
Number of true bed exit detections vs number of false bed exit detections
A reference device and two observers will classify if a bed exit was true
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03901976
Brief Title
ZeroFall - Reliability Testing of Optical Sensor to Detect Bed Exit for Patients in Hospital
Official Title
ZeroFall - Reliability Testing of Optical Sensor to Detect Bed Exit for Patients in Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
Not enough resources in place; COVID-19 pandemic impedes working on the project and travelling within the EU
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
November 5, 2020 (Actual)
Study Completion Date
November 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Healthcare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium of Mixed Origin
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bed Exit Detection On
Arm Type
Other
Arm Description
prevention of fall by a true bed exit detection
Intervention Type
Device
Intervention Name(s)
bed exit detection
Intervention Description
bed exit detection to avoid patients fall
Primary Outcome Measure Information:
Title
Number of true bed exit detections vs number of false bed exit detections
Description
A reference device and two observers will classify if a bed exit was true
Time Frame
12-15 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients with risk of fall more than 24 hours on the ward
Exclusion Criteria:
Patients with predominantly palliative needs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian P Subbe, MD
Organizational Affiliation
Ysbyty Gwynedd Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ysbyty Gwynedd
City
Bangor
State/Province
Wales
ZIP/Postal Code
LL57 2PW
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ZeroFall - Reliability Testing of Optical Sensor to Detect Bed Exit for Patients in Hospital
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