Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04797533 |
| Other study ID # |
IRAS 258273 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 14, 2019 |
| Est. completion date |
October 15, 2020 |
Study information
| Verified date |
March 2021 |
| Source |
Surrey and Borders Partnership NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Monitoring of Biologic Signals of Elderly Patients
Description:
The Body Information Management Systems (BIMS) are advanced biological sensors which monitor
human behaviour, activity and basic vital signs. There is a combination of four separate
ultra-sensitive weighing scales attached to each of the individual legs of a hospital bed
measuring:
- Micro-changes in weight distribution
- Activity/sleep pattern
In addition to the bed-based system, there will be a wrist worn wearable (Samsung fit gear)
that will monitor participants when they are both in and out of bed. These are about the size
of a small watch, light weight, water resistant, and will be worn 24/7 by participants. These
measure:
- Movement and sleep
- Heart rate The set up will remain flexible throughout the study allowing re-design to
accommodate the needs of participants and staff.
Device testing
Devices (BIMS & wearables) have been tested at the UoS (University of Surrey) 'living lab', a
mock 'real world' environment created to test reliability and communication interfacing
between the device, gateway, servers and user interface. The BIMS device itself has been
tested to ensure reliability and sensitivity of measurement and communication of data. As
part of this pilot, further testing of the sensitivity and specificity of the BIMS system
will be undertaken.
The bed sensor system does not have CE certification. MinebeaMitsumi acknowledge and confirm
they retain responsibility for the functionality and safety of the BIMS systems and
associated equipment.
For the purposes of the present project, the devices are not intended to investigate,
diagnose or treat any disease, injury or condition, thus are not defined as a medical device.
They collect data for informational purposes only.
This study is interested in the quality of the data produced in an inpatient environment,
user experience and workforce impact. The study shall assess the utility of the data in an
inpatient environment.
The Samsung fit gear wearable is a mass produced activity tracker product that has been CE
marked. Twenty of these wearables have been purchased by SABP to be deployed in technology
based projects and are covered by the project's insurance.
4.1.2 The User Interface
Data will be collated via the Internet of Things to a dashboard view (the user interface)
which will be monitored by staff on the ward and the research workers on the ward involved in
this specific project, including the study specific Research Assistant (RA), Research nurse
(RN) and Health Care Assistant (HCA)
As the study progresses, clinical and technical knowledge gained will facilitate the
development of algorithms that may in the future have the potential to inform clinical
decision-making. Actual changes to any care pathway would be beyond the current scope of this
project.
The User Interface
Part of the research aim is to develop a user interface with which to present the data. This
is likely to take the form of a user interface that shows the relevant bed being monitored
and the relevant biometrics based on changes in weight distribution. Alongside this
representation will be additional data derived from any wearable worn by the patient
occupying that particular bed.
4.1.3 Deployment
Once the testing of the devices and data flow has been completed within the UoS living lab,
the devices will be deployed onto the ward. Members of UoS Technical Team will deploy the
devices on the ward and provide any maintenance or trouble-shooting as required.
Mock ward set-ups have been conducted to assess any requirements for changes to the
infrastructure and to ensure risk and safety issues have been considered. As a part of this
process of continual development, electric leads between the devices are being housed within
the structure of the beds, and the device control unit is being secured to the underside or
headboard of the bed so it cannot be removed by patients.
Once the investigators are in a position to deploy, the Consultant Psychiatrist and Ward
Manager will advise on which patients will be appropriate for the project. Prospective
participants will be informed about the project, provided accessible information, and consent
will be sought. Deployment will occur within 2 weeks of consent.
4.1.4 Reporting Issues
The BIMS system will be configured in such a way so as to send an automatic communication to
the UoS Technical Team when there is a device or data sending issue. User interface issues or
suggested developments will be recorded by the Clinical Project Coordinator, Researcher
Assistant and Ward staff involved in the project, and transferred to the UoS Technical Team
for discussion. There will also be a regular Project Board and Steering Board to update on
progress and address any ongoing issues.
4.1.5 BIMS Development
Part of the present project is to develop the BIMS systems alongside feedback provided during
the project.
Machine learning algorithms:
Requirements and insights will be provided throughout the project. The clinical team will
review received data and advise the UoS Technical Team on development of algorithms and
Machine Learning to advance the monitoring and alert functionality. Data from initial stages
of the project will facilitate the design of clinically-led and patient/psychiatric
condition-driven algorithms. The main work will focus on developing adaptive Machine Learning
solutions to assist in extracting and identifying changes in health status, associated
patterns and anomalies from the raw data (or pre-processed signals). Over the course of the
project it is hoped that the system will indicate data patterns relevant to specific
conditions, and detect trends and changes using personalised patient specific algorithms.
MinebeaMitsurni will provide the initial signal processing work to UoS, based on prior
testing, and SABP will provide clinical expertise to develop how the data is presented.
New algorithms will be tested, deployed and refined based on a review of their impact on
understanding of participant presentation and treatment decision-making. Evaluation feedback
will be provided to UoS by clinicians and service users. The research nurse will gather the
data which will be fed back to UoS.
Where algorithms monitoring certain data fields highlight a change in health status or
activity levels, an alert may present on the user interface to indicate to clinicians a
change has occurred. These alerts, and their associated algorithms, will be continually
developed and refined as the project progresses.
4.1.7 Naturalistic data
Naturalistic data will be gathered with which to make comparisons with those using the BIMS
technology. This shall comprise of information regarding the average time of ward stays over
the past year.
4.2 Recruitment
Service Users will be approached for consent to the study if they are allocated one of the
five beds where devices are installed. They will be given the participant information sheet
and given verbal information about the study and given the opportunity to ask questions. If
they wish to proceed, they will be asked to sign an informed consent form and baseline
information will be obtained.
If the service user allocated to the device bed does not wish to participate in the study,
other service users on the ward will be approached to participate. If another individual
wishes to provide consent for the study, the devices will be moved onto their bed.
Withdrawal
A participant may withdraw from the study at any point without giving a reason. They may also
be withdrawn from the study for reasons including, but not limited to:
1. Withdrawal of consent
2. Death
3. Serious Adverse events affecting participation in the study. This decision will be made
between the PI, ward staff, monitors and research worker.
4. Participant becomes ineligible (see Inclusion/Exclusion Criteria)
5. Inability to continue participation due to loss of physical capacity
6. Participants fail to comply with protocol requirements
4.3 Measurements
Service users (BIMS)
- Demographics (including diagnosis)
- HADS - Hospital Anxiety and Depression Scale (weekly) (Zigmond & Snaith, 1983)
- PSQI - Pittsburgh Sleep Quality Index (Weekly) (Buysse, Reynolds, Monk, Berman & Kupfer,
1989)
The HADS is a 14-item scale with 7 questions on anxiety and 7 on depression. A meta- analysis
found it to have good internal consistency for the depression scale and anxiety scale with
mean Cronbach's alphas of .82 and .83 respectively (Bjelland, Dahl, Haug & Neckelmann, 2002).
This scale was chosen as includes both anxiety and depression so negates the need for
separate, longer scales.
The PSQI is a 24-item scale measuring sleep disturbance. It has been shown to have good
test-retest reliability (.87) and good validity (Backhaus, Junghanns, Broocks, Riemann &
Hohagen, 2002).
Clinical information will also be gathered to assess the potential impact of the BIMS system
on treatment pathways. This may include medication changes, and severity and progression of
illness. Clinical information will also be collected to help explore the future utility of
the systems in an inpatient environment.
The total length of stay of each participant will be recorded at the point of discharge.
Due to the developmental nature of the study, the information gathered at each interview may
vary due to the present requirements of the study.
Staff
Staff will have two main semi-structured interviews, one at the beginning (their expectations
of the devices) and one at the end of the study (their actual experience of the devices).
The interview schedule at the end of the project is subject to change depending on the
development of the system during the project. Interviews will be recorded and transcribed for
analysis by a member of the sponsors research team. Participants will be informed of this.
Interviews have been chosen as the method of data collection to gain as much depth as
possible in the data which is necessary for the small sample size of the pilot
In addition to this, staff will be consulted on a fortnightly basis regarding the impact of
the BIMS system. If staff leave their role during the study the final interview will happen
before they leave and their length of time in the study will be noted.
The chief investigator or an appointed individual will be interviewed on a fortnightly basis
regarding the use of the BIMS on the ward including its use by staff any issues encountered
and any developments that are required.
Other
In addition to the impact on service users and staff the present project also aims to
evaluate the cost of care, resource management and quality of care. This will be derived from
qualitative and quantitative analysis on the semi-structured data.
