Study title: INCLUDE‑CKD: INCLUsive Digital care for Chronic Kidney Disease
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 are the possible risks and benefits of taking part?
This study involves reviewing information that has already been collected as part of your routine NHS care. You will not be asked to attend any additional appointments, complete questionnaires, or change your treatment in any way.
There are no physical risks associated with this study. The main potential risk relates to the use of personal health information for research purposes. We take strict steps to protect your confidentiality. Identifiable information is accessed only by authorised NHS staff within the Trust, and data used for analysis are pseudonymised so that researchers do not see names, NHS numbers or other direct identifiers.
There is no direct clinical benefit to you from taking part in this retrospective study. However, the findings may help the NHS understand how digital kidney care is being used in real-world practice and whether it is working fairly and effectively across different patient groups. This may help improve services for people living with chronic kidney disease in the future.
Your care will not be affected in any way, whether or not your information is included.
How will we use information about you?
We will need to use information from your medical records and the MyRenalCare digital platform for this research project. This information will be used to help us understand how digital kidney care is used in practice and whether it affects outcomes.
We will use the following information about you for this study:
Your name, contact details and NHS number
Demographic information such as age and sex
Clinical information related to your kidney disease and care
Information from routine clinical systems, including blood test results, blood pressure, clinic attendance and hospital admissions
Other health information necessary to address the aims of the study
We will need to use this information to do the research and to check your records to make sure the research is being done properly.
People who do not need to know who you are will not be able to see your name, NHS number or contact details. Your data will be coded so that researchers work with pseudonymised information only.
Portsmouth Hospitals University NHS Trust is the sponsor of this research and is responsible for looking after your information for the purposes of this study.
We will share this information with people who are taking part in the research, including members of the research team and organisations that help us with the research, in line with the purposes of the study.
International transfers
Your data will not be shared outside the UK.
How will we use information about you after the study ends?
Once we have finished the study, we will keep some of your data so we can check the results and write our reports. We will write reports in a way that no one can work out who you are.
We will keep your study data for a maximum of 10 years after the study ends. After this time, your data will be anonymised or securely destroyed in line with Trust policy.
What are your choices about how your information is used?
You can stop being part of the study at any time, without giving a reason. If you choose to stop:
We will keep information about you that we already have that is necessary to maintain the validity of the research, unless you ask us not to.
If you do not want us to use your data any further, tell the research team and we will stop. This may mean your data cannot be used in the study.
You also have the right to ask us to access, remove, correct or delete data we hold about you for the purposes of the study, or to object to our processing of your data. We might not always be able to comply with these requests if it means we cannot use your data to do the research. If so, we will explain why.
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
Inclusion in this study will not change the care you receive. No additional information will be added to your medical record as a result of this research. Clinical decisions about your treatment will continue to be made in the usual way by your healthcare team.
Identifiable information is accessed only by authorised NHS staff within the Trust for the purposes of secure data extraction and governance. Researchers analysing the study data work with pseudonymised datasets and do not require access to direct identifiers for analysis.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.
If you use the MyRenalCare platform, we may use information about how you use the system, such as how often you log in, how frequently readings are submitted, and the number or timing of secure messages. We will not access or analyse the content of any secure messages or consultations exchanged through the platform.
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.
How do I opt out?
If you are happy for your existing information to be used as described, you do not need to do anything. If you do not want your information to be used for this study, you can opt out within 4 weeks of receiving this information by selecting the “Opt out of this study” option within the MyRenalCare app.
You may also opt out by contacting the research team:
Renal Research Office
Portsmouth Hospitals University NHS Trust
Telephone: 023 92 286000 Ext 1050
Choosing to opt out will not affect your care or your access to MyRenalCare.
What if I want to withdraw later?
You can withdraw from the study at any time without giving a reason. Withdrawing will not affect the care you receive now or in the future.
If you wish to withdraw, please contact:
Renal Research Office
Portsmouth Hospitals University NHS Trust
Telephone: 023 92 286000 Ext 1050
If you withdraw, no further information will be collected about you. Data already included in anonymised analyses may not be able to be removed, as it will no longer.
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:
Renal Research Office
Portsmouth Hospitals University NHS Trust
Telephone: 023 92 286000 Ext 1050
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:
Renal Research Office
Portsmouth Hospitals University NHS Trust
Telephone: 023 92 286000 Ext 1050
Chief Investigator:
Dr Amir Bhanji
Consultant Nephrologist
Wessex Kidney Centre
Portsmouth Hospitals University NHS Trust
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.researchoffice-groupmailbox@nhs.net
Phone: 02392 286000 (ask for R&D office)