INCLUDE-CKD: Participant Information Sheet
You are being given this information because you are currently receiving kidney care at the Wessex Kidney Centre and have used, or been offered, the MyRenalCare digital platform as part of your routine NHS care.
This study aims to understand how MyRenalCare is being used in everyday practice and whether it supports people with chronic kidney disease (CKD) equally across different ages, backgrounds and circumstances. We will do this by carefully reviewing information that has already been collected during routine care. You will not be asked to attend any additional appointments, complete questionnaires, or change your treatment.
The study is being carried out by Portsmouth Hospitals University NHS Trust and is part of NHS‑supported research to improve kidney services and digital care. The findings will be used to help the NHS understand how digital tools can be used safely, fairly and effectively for people with long‑term conditions.
Taking part in this part of the study is optional. If you are happy for your existing information to be used as described, you do not need to do anything. If you prefer not to take part, you can opt out at any time by contacting the study team.
Why we are inviting you
We are inviting you because you have chronic kidney disease (CKD) and are already using, or have been invited to use, the MyRenalCare digital platform as part of your routine care at the Wessex Kidney Centre.
MyRenalCare is a digital self-management system that helps people monitor their blood pressure, weight, symptoms and treatment plans from home. It is used by around 2,000 patients across the kidney service, including people with early-stage CKD, those on dialysis, and others preparing for a transplant.
We want to understand how MyRenalCare is being used in real-world settings and whether it offers the same benefits to people of different ages, ethnicities, and levels of digital confidence or deprivation. To do this, we are reviewing the existing information of patients like you, alongside anonymised records from patients with similar conditions who were not using the platform.
Your information will help us build a clearer picture of how digital tools can support people living with kidney disease and whether we need to improve access or make changes to ensure care is equitable and inclusive.
What the study involves
This study is a retrospective review of health data. That means we are looking back at information that already exists in your NHS records and from your use of the MyRenalCare platform. You do not need to attend any extra appointments, complete any questionnaires, or change anything about your current care.
What data we will collect and how it will be used
We will collect and review information that has already been recorded as part of your routine NHS care and your use of the MyRenalCare platform. You are not being asked to provide any new information.
We will collect the following types of data:
· Basic information:
Age, sex, ethnic background, and your postcode (used to understand social and geographic factors)
· Kidney health records:
Data from your kidney clinic including blood test results (e.g. kidney function or “eGFR”), blood pressure, and prescribed medications
· Healthcare use:
Records of any hospital visits, outpatient appointments, A&E attendances or admissions related to your kidney health
· MyRenalCare activity:
How often you use the platform, which features you use (such as entering readings or messaging staff), and how long you continue using it
· Travel data:
We will estimate how far you travel to your kidney clinic appointments using anonymised postcode-level data
· Healthcare costs:
Using NHS tariffs, we will estimate the cost of your kidney-related care
All of this information will be used to:
Understand whether the MyRenalCare platform is being used equally across different groups of patients
Look at whether people who use the platform have better health outcomes or reduced hospital visits compared to those who don’t use it
Explore whether digital support tools can help make care more efficient, inclusive, and environmentally sustainable
Importantly:
We will not access or use any information not already held in your health records
All data will be anonymised before analysis—this means no names, NHS numbers, or other identifiers will be included
Your personal care will not be affected in any way, and your clinical team will not know whether or not your data has been included in the study
Data will be securely stored within the NHS Trust’s research systems and analysed only by authorised researchers. You will not be identifiable in any outputs, reports, or publications.
How your data will be kept secure and confidential
We take your privacy and the protection of your data very seriously. All information used in this study will be handled in accordance with:
The UK General Data Protection Regulation (UK GDPR)
The Data Protection Act 2018
NHS information governance policies
Health Research Authority (HRA) and Research Ethics Committee (REC) guidelines
Your identifiable personal information (such as your name, NHS number, full address, or contact details) will not be used in this research. Instead:
We will extract data already held in your NHS clinical records and the MyRenalCare system.
This data will be pseudonymised—your identifying details will be removed and replaced with a study ID.
Researchers analysing the data will only access this pseudonymised dataset.
No individual will be identifiable in any reports, presentations, or publications from this study.
Your data will be stored securely on password-protected NHS servers within Portsmouth Hospitals University NHS Trust (PHU). Access will be limited to authorised members of the research team. Data will never be transferred outside of the UK.
Some of your data (e.g. MyRenalCare platform activity) may be shared with the company that developed and supports the platform, Ardia Digital Health, for technical evaluation purposes. However:
Only anonymised data will be shared (no names, dates of birth, addresses, or NHS numbers)
The company has signed a formal data-sharing agreement with the NHS and follows strict data protection and confidentiality requirements
They will not be able to identify you in any way or use the data for marketing or commercial profiling
We will retain anonymised research data for up to 5 years after the end of the study, in line with national guidelines. This allows us to respond to audit or regulatory requests and to conduct further analysis that may benefit kidney care.
You can opt out of the study at any time (see below) and this will not affect your care or the services you receive.
Who will see my information and what will be shared
Only members of the approved research team will have access to the pseudonymised data used for this study. This includes:
Researchers at Portsmouth Hospitals University NHS Trust (PHU)
Collaborators from the University of Portsmouth
Named co-investigators who are directly involved in the analysis or oversight of the study
All team members are trained in confidentiality, data protection, and NHS research standards. They will only access the minimum data necessary to carry out the research tasks they are responsible for.
No identifiable information—such as your name, address, date of birth, NHS number, or contact details—will be shared with researchers outside your direct clinical team.
Some elements of anonymised system usage data (e.g. how often patients log in, or submit blood pressure readings) may be shared with Ardia Digital Health, the company that maintains the MyRenalCare platform. This is solely for the purpose of understanding how the platform is being used and improving future versions of the technology. Ardia Digital Health will not receive any data that could identify you.
We will not share your data with insurance companies, employers, or marketing companies. It will never be used for commercial profiling.
The findings from the study will be published in medical journals, shared with kidney charities, and presented to NHS policymakers. These results will be based on group-level data (e.g. how people from different backgrounds use the platform), and no individuals will be identified in any reports or publications.
You can withdraw from the study at any time (see Section 8), and your data will no longer be used.
Your rights and opt-out process
Because this part of the study uses information that is already being collected as part of your usual kidney care, we are using an opt-out model. This means you do not have to do anything if you are happy for your data to be included.
If you do not want your information to be used in this research, you can contact the research team at any time and ask for your records to be removed from the study. This will not affect your current or future care in any way.
You can opt out by:
Emailing the study team at: xxx
Calling the Research Team on: 023 9228 6000 ext 1234
You will be given 4 weeks to consider this information. If we don’t hear from you in 4 weeks from this email, we will assume you are happy to take part.
Under UK data protection law, you have the right to:
Access your personal data
Request corrections if any data is inaccurate
Request that your data is no longer used in the research
Complain to the Information Commissioner’s Office (ICO) if you are unhappy with how your data is being handled (ico.org.uk)
Please note, once the data is fully anonymised and included in the analysis, it may not be possible to remove it because it will no longer be linked to your identity.
If you have previously registered with the NHS National Data Opt-Out, your preferences will be respected, and your data will not be included unless required under legal exemptions.
What happens next
You do not need to do anything right now.
If you are happy for your health information to be included in the study, there is no need to contact us or sign anything. We will begin reviewing the anonymised data after a four-week period has passed from the time you receive this information.
If you decide you do not want to take part, you can let us know using the contact details below. We will make sure your data is excluded from the study. This will not affect the care you receive in any way.
If you have any questions or would like to discuss the study with a member of the research team, please feel free to contact us using the details below:
Email: xxx
Phone: 023 9228 6000 ext 1234
You are welcome to ask questions at any point. Thank you for taking the time to consider this important research.
Who is organising and funding this study
This study is being led by the research team at Portsmouth Hospitals University NHS Trust (PHU) in collaboration with the University of Portsmouth.
The project is funded by the National Institute for Health and Care Research (NIHR) through its Invention for Innovation (i4i) FAST funding programme. NIHR is a government-funded organisation that supports high-quality health and care research for the benefit of patients and the NHS.
The study has been reviewed and approved by a Research Ethics Committee and the Health Research Authority, who ensure that patient safety, rights, and data protection are fully respected throughout.
The MyRenalCare system used in this study is provided by Ardia Digital Health, a digital health company working in partnership with the NHS. Ardia will not receive any personal data and will not be involved in identifying you or contacting you directly.
Who to contact if you have a question or concern
If you have any questions about this study or would like to know more about how your information is being used, please contact:
Email: pho-tr.renalresearchteam@nhs.net
Phone: 02392 286000 (ask for Renal Research Team)
If you have a concern or complaint about the way the study is being conducted, you may contact:
Research and Development Department
Portsmouth Hospitals University NHS Trust
Email: pho-tr.renalresearchteam@nhs.net
Phone: 02392 286000 (ask for R&D office)