What does the trial involve?

There are two groups: the normal care group (no symptom tracking is undertaken), and the symptom tracking group.

If you agree to take part in the trial, you will receive information from the study team at The University of Manchester about which group you are in. When you consent to take part, the medical team at the local hospital will not know which group you will be in when they recruit you to take part.

Patients in the normal care group will not be asked to track their RA symptoms using the app. Patients in the symptom tracking group will be asked to use the REMORA app to enter their symptoms. Patients will be given user instructions, including information about how to download and use the app.

After downloading the app to your phone or tablet, you will automatically receive notifications from the app to complete daily, weekly and monthly questions. We ask you to record your symptoms daily. If you haven’t completed the daily questions before 18:30, you will receive a notification. The daily questions are short and ask, for example, how your pain is today?

In the app, the weekly tab will show a ‘Due by’ date. When the weekly questionnaire becomes available, you will receive a notification at 15:30 to complete the questions. You have 3 days to complete the weekly questionnaire before the option becomes unavailable until the following week. You do not have to wait for the notification to complete the questionnaire on the day it becomes available.

Questions include asking you to perform a tender and swollen joint count (we have an instructional video to help you with this) and whether you have experienced a flare in the last week.

The monthly questions ask about your current level of illness. The monthly questionnaire will be available to complete for 7 days before the ‘Due by’ date. You will receive a notification to complete the monthly questionnaire at 12 noon on the day the questionnaire becomes available. You do not have to wait for the notification to complete the questionnaire on the day it becomes available.

Once this information is collected, your health care professional will then be able to access your symptom tracking data at your next clinical appointment.

Both the normal care and symptom tracking groups will be invited by email to complete a web-based survey when you join the trial, and then at 3, 6, 9 and 12 months. The survey will capture things like your quality of life and information about your rheumatology appointments. You will be emailed a request to fill in the web-based survey. The study team at The University of Manchester will also send you reminders about the survey if you haven’t completed them.

The trial will also involve a member of the care team at the hospital accessing some information from your medical records. The information collected will include details such as your age, gender, ethnicity, smoking status, body mass index (BMI), diagnosis and duration of disease, recent disease activity assessments, medications, and any other illnesses. The study team at The University of Manchester will not have direct access to your medical records, but will have a copy of the data extracted.

If you choose to join the trial, you will also be asked to consider being interviewed so that we can better understand patients’ experience of normal care compared with that of patients who use the app to record their RA symptoms and were able to view the app data with their health care professional.

We will also ask you if you would be happy for a clinic appointment to be observed by a member of The University of Manchester study team. This will allow us to explore how the symptom tracking information is used during the consultation compared with normal care.

If you choose not to take part in the trial, you may still be asked to consider being interviewed so that we can understand why you did not want to take part.

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How many times will I need to visit the clinic?

You will continue to receive your usual treatments and attend clinical appointments as normal. No additional appointments or clinic visits will take place as part of the REMORA2 trial.

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What is the length of the trial?

All patients in both groups (normal care and symptom tracking) that take part in the trial will be followed for at least 12 months from date of entry to the trial. Some patients may be followed for up to 15 months.

No patients will be followed for longer than 15 months. This is because some patients may not have a clinic appointment scheduled around 12 months, and so we may need to follow you until the next clinic appointment after 12 months.

If we would like you to be involved in the trial for more than 12 months, the study team at The University of Manchester will let you know.

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Can I stop taking part at any time?

It is up to you to decide if you want to take part. You can contact The University of Manchester study team if you wish to withdraw.

If you decide to take part, you are still free to withdraw at any time without giving a reason and without detriment to yourself. The care you receive from your health care professional will not be affected.

If you are part of the symptom tracking group, but decide you no longer wish to track your symptoms during the trial, you may wish to stop using the app, but not formally withdraw from the trial. If this is the case, we may ask you to participate in an interview. This will be optional and you can let us know if you are happy for us to contact you about this in the consent form.

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What are the differences between what is being studied and the standard treatment?

The study involves looking at patients receiving normal care compared with patients receiving normal care and using the REMORA app to record information about their RA symptoms.

Some trial participants will receive usual care, i.e., the care you would normally receive if you had not been asked to take part in the REMORA2 trial.

Some participants will be asked to use the REMORA app to track their RA symptoms. The information the patient records about their symptoms will be made available to their health care professional at the hospital during the clinic appointment.

The REMORA2 study will look at whether patients whose doctor can view this extra information about their RA symptoms, captured via the REMORA app, do better than patients whose doctor does not have this information available to them.

All trial participants will continue to receive their usual treatments and attend clinical appointments as normal.

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What is randomisation?

Randomisation involves putting people in a research trial into different groups without taking any similarities or differences between them into account. A randomised controlled trial is a study in which people are randomly placed into groups to test a treatment or an intervention.

In the REMORA2 trial, participants will be randomly assigned to either the normal care group or the symptom tracking group.

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For a person to provide informed consent to take part in a research study, they must be given full information about what it means for them to take part, the purpose of the study, the intervention that will be provided, and the benefits and risks of taking part.

Enough time to understand and reflect on that information must be allowed before giving consent. You must sign a written consent form before being enrolled in a clinical trial. You would need to provide written informed consent to participate in the REMORA2 trial.

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