Frequently asked questions

We know that recognising quickly if a person’s health is deteriorating gives doctors and other health care professionals a chance to intervene early and stop problems getting worse. That can make treatment more effective and means patients can recover better. Often it even avoids admissions or urgent visits to hospital.

In this research study we are testing if we can find out really early when someone is becoming ill and may need medical help. We are testing if taking regular health measurements can give us this information. As our researchers will only analyse all the information once the study is completed, you will not benefit from taking part in this study. Nevertheless, we hope that people in the future with similar health problems will receive better treatment earlier, helping them live longer happier lives.

The regular health measurements we would like you to take will be taken using new medical technologies that are installed on a smartphone, tablet or smart wristband – we call them “Smart Devices”. They are very simple to use and can read vital signs about your health such as your blood pressure, heart rhythm and oxygen saturation just by using the camera on a smartphone or tablet. The wristband can be worn constantly like a normal wristwatch and records sleep patterns. This means they are far less intrusive than the traditional medical devices used to take these readings and you don’t need to go to a doctor’s surgery or hospital to have them taken.

In addition to the data we collect from you directly, we also plan to collect Health, Social Care and Environmental data from the area you live in, such as weather and air quality. This is so that we can produce a very detailed report on all the things that affect people’s health and wellbeing.

Once we have measurements from a large number of people, scientists will use Artificial Intelligence to see if they can use the information to spot when treatment from a doctor would have been beneficial. We will use all the information we receive to write reports on how the NHS can improve patient care by using these types of technologies and Smart Devices.
 
This study is being paid for by the NHS and it is being run by your local NHS organisation, Lincolnshire Clinical Commissioning Group (CCG). Helicon Health and Philips are private companies that Lincolnshire CCG are paying to provide the electronic medical devices, securely store and analyse the data, and write up the results. Lincolnshire CCG, the NHS Health Research Authority and The West Midlands Solihull Research Ethics Committee have reviewed and approved the study design.

This study aims to answer the research question:

“If information about patient behaviour, conditions and events captured from wearables, monitors and other smart technologies, can predict illness and demand for services, then providing these technologies to patients will enable providers to pre-empt illness and redirect demand, or design new services.”

For the study, we are including people living in the Lincolnshire area who have two or more long term health problems. They might be living in a care home or they might be living in their own homes.

Your GP has selected you based on your medical history and has invited you on our behalf.

No information about you has been or will be passed from your GP to the Research Team until you agree to take part in the study.

No, you do not have to take part in this study if you do not want to.

The NHS will not treat you any differently if you decide not to take part. If you start the study, you can choose not to finish it.

Your usual healthcare will not change if you decide to take part in the study.  You will continue to take your medication and attend your healthcare appointments as usual. You will not be asked to change anything about your day -to- day life.

If you agree to take part in this study after you have read all the information provided in the study information sheet, you can complete your consent form online.

Optima Systems are the organisation responsible for making sure your personal data is kept safe and secure during this study. They are also responsible for sending you the equipment you need to take part and providing you with any support you need. You are welcome to speak to a friend, relative or carer before you decide to take part.

If you have read all the information provided and would still like to ask more questions, you can contact Optima Systems on 0808 280 8048. Optima Systems are part of the study team and will be able to help guide you on how to complete and submit your consent form and will be able to answer any questions you might have.

We would like you to let us know if you will be taking part within one week of receiving your invitation. If we do not receive your consent form within two weeks, we will assume you do not want to take part and will not contact you again regarding this study.

We will answer your questions and confirm your consent. Once you have read all the study information you can provide your consent by completing the online consent form here [insert consent form link]. If you have any questions you can call us on 0808 280 8048.

Once you have consented to take part, you will be enrolled in the study and sent Smart Devices to use.

Once you receive your Smart Devices you can start using them to take your health measurements straight away. The Smart Device you receive will either be a tablet or a smartphone and possibly a wristband.

All the Smart Devices we are using are connected to the internet via WiFi. This means that measurements can be sent directly from the smartphones, tablets or wristbands to the Philips HealthSuite Digital Platform (HSDP) which is where scientists will analyse the data.

Your data from the Smart Devices will be collected until the study is complete. We would like you to take part in the study for up to six months. You will not be asked to take part any longer than six months in total and you can stop taking part at any time if you do not want to continue.

This study is purely observational and the researchers will only analyse the data once a large number of people have completed the study. The data they work with is pseudonymised which means that any information that identifies you as an individual has been removed or replaced and your ‘real world’ identity is not revealed to them. As a result, your medical treatment will not be affected by taking part in this study. 

We have set up this study very carefully. The risks of harm to you are the same as or less than the risk for you of using any normal smartphone, tablet or smartwatch. We are using Smart Devices that are safe for anyone to use and have been carefully tested so that they cannot harm you.

It is probable that you will not benefit from taking part in this study. We hope that people in the future with similar health problems will receive better treatment earlier, helping them live longer happier lives.  You will have helped to make this happen because you took part in this study.

Yes, your GP to be involved in this study and necessary information about you will be exchanged between your GP and the Research Team.

No, you will not be given any money or gifts to take part in this research study.

This study is being paid for by the NHS and it is being run by your local NHS organisation, Lincolnshire Clinical Commissioning Group (CCG). Helicon Health and i5Health, Optima Systems and Philips are private companies that Lincolnshire CCG are paying to provide the electronic medical devices, securely store and analyse the data, and write up the results. Lincolnshire CCG, the NHS Health Research Authority and The West Midlands Solihull Research Ethics Committee have reviewed and approved the study design. 

Optima Systems

Optima Systems are an IT company that specialise in the coding and security of data. In this study Optima Systems will keep your personal data safe and be responsible for:

• collecting and securely storing your consent form
• sending you the devices you need to take part in the study
• help you with any questions or problems you have with the devices during the study

Optima Systems will have access to your personal contact details in order to enable them to send you the devices. They will also ensure that any information that identifies you as an individual is removed or replaced so that your ‘real world identity’ is not revealed to the Research Team or in the data that is collected. This process is called pseudonymisation.

Helicon Health and i5Health

Helicon Health are a specialist company that works with the NHS to deliver socio-technical healthcare solutions. They work closely with their partners i5Health. Scientists from Helicon and i5Health will be analysing the pseudonymised data collected during this study to produce reports for Lincolnshire CCG on how technologies like the ones used in this study can benefit people with long term health conditions. 

Philips

Philips are a global company and are specialists in healthcare innovation and technologies. Philips will be storing the pseudonymised data collected as part of this study in a secure environment on their HealthSuite Digital Platform. Scientists from Helicon Health and i5Health will use this secure environment to analyse the study data.

The National Institute for Health Research – Clinical Research Network

The National Institute for Health Research Clinical Research Network supports patients, the public and health and care organisations across England to participate in high-quality research, advancing knowledge and improving care. The Clinical Research Network is comprised of 15 local Clinical Research Networks and 30 Specialties who coordinate and support the delivery of high-quality research both by geography and therapy area. In this study, we might ask your local Clinical Research Nurses to help support you. You will need to give your permission for this on the consent form.

Where can you find out more about how your information is used?

You can find out more about how we use your information:

• at www.hra.nhs.uk/information-about-patients/
• a leaflet available from www.hra.nhs.uk/patientdataandresearch
• by asking one of the Research Team
• by sending an email to [email protected]

This research has been reviewed and approved by the Health Research Authority and the Solihull Research Ethics Committee.