18 GENERAL INFORMATION
18.1 Description of the intended purpose of device.
The Cardionetics C.Net5000 device The C.Net5000 is intended for in-context monitoring of adult patients, where symptoms occur infrequently, or where resting ECG monitoring is unlikely to capture symptomatic or asymptomatic arrhythmia.
Symptoms commonly indicative of arrhythmia include syncope, presyncope, dizziness, and palpitation. Shortness of breath, chest discomfort, weakness, diaphoresis, or neurological symptoms, such as transient ischaemic attack, may also be caused by arrhythmia.
Where clinically appropriate, the C.Net5000 can assist in ongoing monitoring of the frequency of arrhythmia in patients receiving antiarrhythmic medication or rehabilitation therapy. Approximately 95% of patients are suitable for single-channel automated arrhythmia and ST segment analysis. In these cases, the C.Net5000 is able to analyse the ECG for:
- Heart rate, including tachycardia and bradycardia.
- Paroxysmal wide complex tachycardia.
- ST segment depression.
- Atrial fibrillation and flutter.
- RR variability.
- Pauses and arrests.
- Atrial and ventricular ectopic beats.
In the remaining 5% of patients, automated analysis may not be possible due to an abnormal heart beat morphology. The C.Net5000 follows the ACC/AHA Guidelines for Ambulatory Electrocardiography (1999) and excludes:
- Patients with wide morphologies, such as those due to an intraventricular conduction delay. These include, but are not limited to, left bundle branch block, right bundle branch block, and preexcitation syndromes (including Wolff-Parkinson-White syndrome). A wide morphology may also be evident in patients who have previously had a myocardial infarction.
- Patients with significant cardiac axis shift.
- Patients whose size or other physiology results in ECG signals of low amplitude. In these cases, the C.Net5000 can be used as an event recorder
The patient can press the symptom button on the C.Net5000 at any time during the test. The C.Net5000 records a 24-second ECG trace each time the symptom button is pressed, which may show the presence or absence of arrhythmia leading up to the symptom. This can be a powerful diagnostic aid.
The standard Cardionetics C.Net5000 conforms to all the Essential Requirements listed in Annex I of the Medical Devices Directive 93/42/EEC, as embodied in Statutory Instrument SI 2002/618 as amended, for Class IIa Medical Devices. However, for the purposes of the SAPHE trial, the C.Net5000 has been modified by the addition of a Philips low power radio (low power wireless transmitter) module. This is designed to allow wireless communication of the information from the C.Net5000 to the SAPHE system
The C.Net5000 devices will be used in this case as part of the SAPHE project. The SAPHE project is a three year project funded by Technology Strategy Board and Department of Health. The project partners include Liverpool PCT, University of Dundee, BT, Philips, Cardionetics, Docobo and Smart Solutions Research Consultants. One of the objectives of the project is to develop next generation of body worn miniature physiological sensors and to test them with people under real life conditions. A second objective is to combine these physiological sensors with other environmental and activity monitoring sensors to create the SAPHE system and to trial it with people with long term conditions and their carers. The SAPHE system consists of a package of sensors installed in the home linked via wireless to a hub device. The hub then transmits the data from the sensors to a server where it is collated and transmitted to a PC in the office of the professional carer. The trial of the SAPHE system in Liverpool is the subject of this submission for ethical approval
The objective of the trial is to assess the effect of the technology on the user and their informal carers and how their professional carers can use the information provided to help them manage the person’s care.
The devices will be used in the SAPHE trial which can be summarised as follows:
A package of SAPHE sensors will be installed in the homes of 20 patients selected by the Community Matrons (CMs) who are currently administering and delivering their care (The intervention group). The data collected by the sensors will be made available to the CMs through terminals in their offices. No personal information will be stored with the SAPHE data and only the CM will be able to link the individual to the SAPHE data record. No attempt will be made to fuse SAPHE data with the electronic care record held by the CM. A group of 20 similar patients will be identified (the comparison group) and compared with the intervention group. The comparison will make use of the record of their activity that the CMs routinely complete. The objective of the trial is to investigate how SAPHE technology could support patients and their informal carers, provide CMs with a toolkit of information that helps them to manage their patients and to change the way service is prioritised and delivered
The start of the trial will be staggered with the number of patients on the trial rising over a period of eight weeks to the full 20 patients (This allows for 33% of patients to decline to be involved in the trial. If no patients decline then the trial will be fully operational in six weeks). For several practical reasons this is preferable to trying to arrange that all 20 patients (and 20 comparison group patients) are ready at the same time. There will be a staggered finish as well so that all patients receive approximately the same exposure to the technology.
At all times the CM is in control. She will select the patients, work with members of the SAPHE team to devise a package of SAPHE sensors, explain the trial to the patient (and any relevant informal carers), obtain informed consent and in extremis stop the trial for a particular patient if she feels continuing is not in the patient’s best interest.
In addition to that, the device will be used in Lab Tests at Imperial College for testing the system with healthy subjects and actors before installation in patients’ houses, and alongside the patient trials, to validate the system and respond to new research questions as they arise. Two sets of consent forms have been developed: for patients (study 1) and for lab tests (study 2).
It is important to note that all sensing devices used in the Imperial College C.Net5000 sensor are standard commercially available products and in current use.
A list of all sensors involved in the SAPHE system is included below:
Sensor
/Role
/Environmental
/PIR Sensors
(Passive Infra Red)
· Bedroom
· Hall
· Bathroom
· Living Room
· Toilet
· Landing
· Kitchen / · Detects movement of a person (without any identification possible) within the field of view, used for the purposes of:
· Room occupancy
· Activity profiles
· Multiple occupancy/visiting
· In/out detection
· Room temperature
Doors – magnetic contacts / · Detects the opening and closing of a door, used for the purposes of:
· Front Door / · In/out detection
· Visitors
· Activity profile
· Back Door / · In/out detection
· External activity
· Activity profile
· Fridge / · Eating related activity
· Freezer / · Cooking related activity
Bed Sensor / · Bed occupancy
· Sleep profile (actigraphy)
Temperature / · Internal vs. external temperature differentials
Scales / · Weight
Body Worn
/e-AR – Activity and SPO2 / · Blood oxygen saturation
· Heart rate
· Motion characteristics/profile (in house and external)
ECG / · ECG events (cardiac disturbances)
· Heart Rate
· Heart Rate Variability
Home Unit
/Blood Pressure / · Blood pressure long term trend
Table 1: Sensor list showing sensors that could be included in the SAPHE patient trial systems and the Lab Tests.
18.2 A letter from the Local Research Ethics Committee which has approved this trial
The trial is being submitted to Liverpool Children’s Research Ethics Committee and we will keep the MHRA team informed about its progress.
Full title of study: “A Demonstration of the Role and Effectiveness of the SAPHE system to enhance care delivery in Liverpool PCT”
REC Ref. number: 08/H1002/69
18.3 *Copy of informed consent.
Patient/Volunteer Information Sheet and Consent Form: All patients and volunteers will be given an information sheet explaining the questionnaires, the role of the ambient and wearable wireless sensor devices that will be used in this study as well as the aims of the study. This will also contain a section where the subjects will be asked to consent to wearing the wireless body sensor network, the use of ambient sensors in their surrounding (home installation in the case of the Liverpool patients), and the wireless transfer of their data to a secured central server as part of the trial. It is important to note that participation in this study will in no way change the way the patient is otherwise managed. The patient/volunteer information sheets and consent forms for all the studies are shown over the following pages:
A Demonstration of the Role and Effectiveness of the SAPHE System- Home patient study
PATIENT INFORMATION SHEET & CONSENT FORM
‘You are being invited to take part in a research study. Before you decide it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with others if you wish. Ask us if there is anything that is not clear or if you would like more information. Take time to decide whether or not you wish to take part.
Thank you for reading this.’
1. What is the purpose of the study?
The purpose of the study is to try and identify ways in which we can make use of modern technology to try and help the Community Matrons give you the best care they can. To give you the best care the Community Matron needs up to date information on how you are. Currently she does this by visiting and calling you. We have developed the SAPHE system which automatically collects information about you all the time and sends it the Community Matron so she is getting information about how well you are coping when she can’t visit you. The SAPHE system consists of a number of devices carefully chosen by the Community Matron and installed in your home that collect information about your health and wellbeing. These devices automatically collect information such as your body temperature or whether you’ve had a disturbed night and send it through a box attached to your television set to the Community Matron. She can look at the information on her computer and decide if for instance there is a need to contact you more regularly.
Because we are still developing the system we don’t know exactly which pieces of information will be most helpful to the Community Matrons or the best way to show it to them. So we will be collecting a lot of data and researchers from both Imperial College and the University of Dundee will be analysing the data collected from the devices installed in your house. They will not be able to identify you from the data so your privacy is assured. This data will include information such as the times at which you enter and leave rooms in the house, or the duration of your periods of sleep. Our goal is to provide information on how you are coping on a regular basis to the Community Matron that she can be more aware of your needs. Ultimately, this approach should allow elderly people with health problems to live independently for longer in their own homes.
This study is expected to last up to 6 months.
2. Why have I been chosen?
We want to test out the ideas behind the SAPHE system with as wide a range of people as possible. Those with different long term illnesses, in different domestic arrangements, with different ages and at different stages in their illness.
3. Do I have to take part?
It is up to you to decide whether or not to take part. If you do decide to take part you will be given this information sheet to keep and be asked to sign a consent form. If you decide to take part you are still free to withdraw at any time and without giving a reason. A decision to withdraw at any time, or a decision not to take part, will not affect the standard of care you receive.
4. What will happen to me if I take part?
If you decide to take part in this study then a packages of devices will be installed in your house. This installation will not take more than one day and will not require any refurbishment. The installers may fix some of the devices with screws, for example to walls or doors, but most of the devices will not need to be fixed this way.
You will also be asked to wear an ear worn monitoring device (e-AR sensor) which looks like a hearing aid.
Specifically, the devices that will be installed in your home will be selected from the list shown at the end of this leaflet. Obviously not all these sensors will be installed in your home – only the ones that your Community Matron thinks will give her extra information. We will keep the number of sensors to a minimum.