Delirium of Mixed OriginNCT03901976
ZeroFall - Reliability Testing of Optical Sensor to Detect Bed Exit for Patients in Hospital
A study testing bed exit detection in people with Delirium of Mixed Origin, run by Philips Healthcare at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium of Mixed Origin
- What is being tested?
- bed exit detection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Mar 2019to 5 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with risk of fall more than 24 hours on the ward
Who cannot join
- Patients with predominantly palliative needs
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Delirium of Mixed Origin
- Being tested
- bed exit detection
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bed exit detectionDevice
bed exit detection to avoid patients fall
| Study group | Role | What they receive |
|---|---|---|
| Bed Exit Detection On | Other | prevention of fall by a true bed exit detection Receives: Device: bed exit detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12-15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start25 Mar 2019
- Primary completion5 Nov 2020
- Study completion5 Nov 2020
Why it stopped: Not enough resources in place; COVID-19 pandemic impedes working on the project and travelling within the EU
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium of Mixed OriginStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- 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)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christian P Subbe, MD, Principal investigator, Ysbyty Gwynedd Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901976
- Sponsor's protocol ID
- YGB-PH-CS-BD-2018-02-18
- Status last verified
- Nov 2020
- First submitted
- 28 Mar 2019
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ZeroFall - Reliability Testing of Optical Sensor to Detect Bed Exit for Patients in Hospital
- ClinicalTrials.gov ID
- NCT03901976
- Acronym / sponsor ID
- YGB-PH-CS-BD-2018-02-18
- Conditions
- Delirium of Mixed Origin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough resources in place; COVID-19 pandemic impedes working on the project and travelling within the EU
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Philips HealthcareIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 5 Nov 2020 (actual)
- Study completion
- 5 Nov 2020 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Bed Exit Detection On | Other | Device: bed exit detectionprevention of fall by a true bed exit detection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with risk of fall more than 24 hours on the ward
Key exclusion criteria (1 listed)
- Patients with predominantly palliative needs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bed exit detectionbed exit detection to avoid patients fall | Device | Bed Exit Detection On |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Not enough resources in place; COVID-19 pandemic impedes working on the project and travelling within the EU). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian P Subbe, MD principal investigator
Ysbyty Gwynedd Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bed exit detection in people with Delirium of Mixed Origin, run by Philips Healthcare at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not enough resources in place; COVID-19 pandemic impedes working on the project and travelling within the EU). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of true bed exit detections vs number of false bed exit detections (time frame: 12-15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.