DIGDOWN-CKD: Participant Information Sheet

Thank you for considering participating in our research study. We want to ensure that you fully understand the purpose of the study and what it involves. Please take the time to read through this information. If anything is unclear or if you need more details, please feel free to ask us.

What is the purpose of the study?

Remote monitoring in healthcare involves using technology to collect and transmit patient health data from a distance. This allows healthcare providers to monitor patients' vital signs and other health-related information remotely, enabling proactive interventions and timely medical support. For example, patients can measure their blood pressure at home and use a mobile app or computer to communicate with their doctor, eliminating the need for in-person visits.

Chronic Kidney Disease (CKD) disproportionately affects the most disadvantaged in society, and technology like MyRenalCare may not meet the needs of those who most need access to healthcare.

This study will provide valuable insights into the demographics of MyRenalCare users, their digital adherence, and the overall impact of the app on health outcomes, healthcare costs, and environmental sustainability.  

Why have I been invited?

You have been invited to participate in this study because you are under the care of the Wessex Kidney Centre and you are an existing or new user of the MyRenalCare app.  

Do I have to take part?

Participation in this study is entirely voluntary. You have the right to withdraw at any time without providing a reason.

What will happen to me if I decide to take part?

If you decide to participate in this study, we will collect demographics and data from your medical records such as hospital admissions, dialysis records and blood tests which will be collected and securely stored in our database for analysis. There will be no need for you to attend any extra visits, we will only use existing data.

Are there any possible disadvantages or risks of taking part?

There are no disadvantages to your care if you decide to participate in this study. There are no extra visits or tests in addition to your usual care.

What are the possible benefits of taking part?

We are uncertain about the specific outcomes of this study until we complete our analysis. Although there is no direct benefit to you as a participant, we hope that this research will positively impact and help us understand how a person’s demographics effect their use of the app.   

Will my General Practitioner/family doctor (GP) be informed of my participation?

Your participation in this study will not affect your clinical care, which means your GP will not be notified of your involvement.

Will my taking part in the study be kept confidential?

All data we store about you will be pseudonymised, meaning any personal identifiers will be replaced with unique codes to protect your privacy. This data will be securely stored within Portsmouth Hospitals University NHS Trust on a protected database.

Authorised members of the Portsmouth University Hospitals NHS Trust may be given access to the data for monitoring and/or audit of the study to ensure that the research is complying with applicable regulations. We will store the anonymised research data and any research documents with personal information, such as consent forms, securely so that only authorised people that need to view them can do so.

How will we use information about you?

We will need to use information from your medical records for this research project. 

This information will include your:

  • Initials

  • NHS number

  • Gender

  • Age

  • Ethnicity

  • Postcode

  • eGFR results

  • Data recorded in your MyRenalCare account

People will use this information to do the research or to check your records to make sure that the research is being done properly.

People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.

We will use your postcode, which is routinely collected, along with Google Maps to calculate the distance between your home and your clinic or GP. This information will help us estimate carbon emissions based on the distance travelled and the mode of transportation you use.

We will keep all information about you safe and secure. 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 the data so we can check the results. We will write our reports in a way that no one can work out that you took part in the study. 

We will keep your study data for the minimum period of time required, this will be until the study data has completed analysis, which usually occurs within 12 months following the study end. The study data will then be fully anonymised and securely archived or destroyed.

What are your choices about how your information is used?

If you agree to take part in this study, you will have the option to take part in future research using your anonymous data saved from this study.

You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have. We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.

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

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

Withdrawal from the Study

Choosing not to participate in this study will not impact your treatment or care.

Will I be reimbursed for taking part?

As there is no travel required for this study, there will be no reimbursement for participation.

Who has reviewed this study? Is it safe?

All research in the NHS is looked at by an independent group of people called a Research Ethics Committee. They are there to protect you. This study has been given a favourable opinion by an NHS Research Ethics Committee, well as the Health Research Authority. This means they have read about the study, interviewed the lead researcher, and have no concerns with this project.

It is a requirement that your records in this research, together with any relevant medical records, be made available for scrutiny by monitors from the Sponsor, Portsmouth Hospitals NHS Trust and NHS England, whose role is to check that research is properly conducted and the interests of those taking part are adequately protected.’

What do I do if I have a question, concern or complaint?

If you have any complaints about how you are treated during the study or have any questions, you should contact:

Name & role: Dr Robert Lewis, Chief Investigator

Email: robert.lewis@porthosp.nhs.uk

Phone: 02392 286000 Ext 1000

If you remain unhappy and wish to complain formally, you can do this by contacting your hospital’s Patient Advice and Liaison Service (PALS). PALS can be contacted by phone 023 9228 6309 or email PHT.PALS@porthosp.nhs.uk.

Your normal clinical care will not be altered because of your participation in this study, and you will receive the best medical care available.

In the event that something goes wrong, and you are harmed during the research study due to someone’s negligence then you may have grounds for legal action for compensation against the study sponsor (Portsmouth Hospitals NHS Trust) or the NHS Trust or NHS Board where you received your care. However, you may have to pay for your legal fees. The normal NHS complaints mechanisms will still be available to you.

Thank you for considering participating in our research study.

Please contact the renal research team at Queen Alexandra Hospital on 02392 286000 ext 1050 if you have any further questions about the study.

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