For Trial Participants

RePROM is a pilot study that will test if a full scale clinical trial can be run, in which patients with chronic kidney disease use an online system to send monthly health reports to their clinical team.

Chronic Kidney Disease (CKD) affects around 1 in 7 people in the UK. Some people with advanced CKD may go on to need demanding treatments, such as dialysis which can affect their quality of life.

Some researchers and doctors believe it would be helpful for patients to provide reports about their symptoms and quality of life in between their regular hospital appointments by completing a questionnaire on their computer or smartphone. We call these questionnaires ‘electronic Patient-Reported Outcome Measures’ or ePROMs.

If the ePROM report shows that a patient needs urgent care, we think this will help a doctor take action straight away, rather than waiting until the next clinic appointment. We believe this could help to manage a patient’s CKD and symptoms better.

No-one has tried using ePROM reporting for people with CKD, so we need to find out if it will work. In this study, we will test an ePROM system in a small group of patients with CKD, who are being treated at the Queen Elizabeth Hospital in Birmingham.

This is a pilot study. We will use the results to plan a much larger clinical trial, which will help show if ePROM reporting in the NHS is actually better for patients.

People under the care of kidney specialists who have stage 4 or 5 Chronic Kidney Disease (CKD) can participate in the study. Participants must be aged 18 years or over and be willing to use the online ePROM system.

 We will ask patients participating in the study:

1)      To agree to be closely monitored by their kidney care team for 12 months. As part of this process they would need to fill out a short paper questionnaire approximately every 3 months. At the same time, the research team would need access to their hospital medical notes to help the monitoring process.

2)      Half of the participants would also be asked to complete short electronic questionnaires about their health using a smartphone or computer.

3)      Finally, we will ask participants to consider taking part in a short interview at the end of the study to tell us about their experience.

 We do not know yet if using the ePROM system will have any benefits. We think participants assigned to the ePROM reporting group might benefit from being more closely monitored by the CKD team, but we need to do this study to help find out.

If the ePROM reporting system is shown to be helpful in a large clinical trial, future patients with advanced CKD may benefit from its use across the NHS.

There are no risks to taking part in the study, only the use of participants’ time, as the extra information we collect for the study will make their appointments a little longer.

For participants that are assigned to the ePROM reporting group, it will take time to complete each report – about 10-15 minutes. The ePROM questionnaire will ask about quality of life and symptoms. Sometimes patients can become upset when answering these types of questions. We will therefore give participants a help-line number they can call during office hours if they wish to speak to someone in the CKD team to discuss their concerns. Outside of office hours we will ask them to contact their GP if they have any concerns about their health or care after completing the questionnaire.

We aim to start recruitment for RePROM in June 2018 and recruitment will continue for 12 months. Each participant will be followed-up in clinic every 3 months over a period of 12 months. There should be no need for additional clinic visits purely for trial purposes as visits will be every 3 months, which is in keeping with routine clinical practice for CKD patients.

You can see how recruitment is progressing on the recruitment page.

The Chief Investigator for the RePROM trial is Dr Derek Kyte who is based at University of Birmingham.

The RePROM trial is being co-ordinated by the Birmingham Clinical Trials Unit. (RePROM@trials.bham.ac.uk)

Full contact details for the trial can be found on the contacts page.

Trial Sponsor: RePROM is sponsored by the University of Birmingham. Ref.: RG_16-141

Funding: RePROM has been funded by the National Institute for Health Research Post Doctoral Fellowship Programme. Ref: PDF-2016-09-009.

Research Ethics Committee: RePROM has been approved by the West Midlands research ethics committee. Ref: 18/WM/0013. (approved 23rd Feb 2018).

ISRCTN: ISRCTN12669006

NIHR CRN Study ID: 36497

IRAS project ID: 232960