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RecruitingNAINTERVENTIONAL

Tight Control of Gouty Arthritis Compared to Usual Care

Gout causes painful joint attacks due to urate crystals. Medicines can help, but finding the right dose can be tricky and might even trigger attacks at first. This study is looking at a new way to help people manage their gout called Gout SMART. Patients use a smartphone app and a finger-prick test to monitor their urate levels and get advice on adjusting their medication. We want to see if this self-management approach, compared to standard care, can significantly reduce gout attacks over two years. Your involvement could help improve gout treatment for many.

At a glance

Status
Recruiting
Phase
NA
Sponsor
University of Edinburgh
Enrolment target
125
Start
12 Jun 2025
Estimated completion
31 Dec 2028

What is this study about?

Gout is a type of arthritis that causes sudden, severe joint pain, often in the big toe. It happens when too much uric acid (or urate) in your blood forms tiny crystals in your joints. Medicines are available to lower urate levels and prevent these painful attacks. However, it can take time for these medicines to work fully, and sometimes, starting them or increasing the dose can actually cause a flare-up of gout.

Doctors sometimes disagree on the best way to manage gout medication. Some guidelines suggest regularly checking urate levels and adjusting medicine doses, while others recommend increasing doses only if flares continue. The truth is, many people with gout aren't treated effectively, and some don't get treatment at all. This study wants to find a better way.

We've developed a new approach called Gout SMART. This involves you monitoring your own urate levels at home using a simple finger-prick test and a smartphone app. The app would then give you advice on how to adjust your medication dose to reach healthy urate levels. We've already seen promising results that this approach helps control urate levels better. Now, we want to confirm if it also reduces gout attacks over a longer period.

Key takeaways

  • This study compares a new gout self-management app (Gout SMART) to standard care.
  • It aims to see if the app can reduce painful gout attacks over two years.
  • You'll learn how to check your own urate levels if in the Gout SMART group.
  • Participation involves using a smartphone app and some monitoring over two years.
  • Your decision to join is voluntary, and you can leave at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and have had at least one gout flare in the last year. Your doctor must have confirmed you have gout, and your urate levels must be above a certain point (0.36 mmol/L).

You'll also need to own a smartphone and be able to install and use the Gout SMART app. This is important because the app is a key part of the study.

Unfortunately, you can't join if you can't give your consent, or if you're already on the highest possible dose of gout medication or can't take certain gout medicines due to side effects. People with severe kidney problems or those taking specific medications (like azathioprine or mercaptopurine) that interact with gout medicine also won't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years or older?
  2. Have you had at least one gout attack in the last year?
  3. Has your doctor diagnosed you with gout and are your urate levels high?
  4. Do you own a smartphone and can use apps?
  5. Are you able to provide consent to take part?
Answer every question to see your result.

What does participation involve?

If you join, you'll be one of about 125 people in the study. You’ll be randomly placed into one of two groups: either the 'Gout SMART' group or the 'usual care' group. It's like flipping a coin, so we can fairly compare the two approaches. For everyone, we'll create a personal treatment plan based on your kidney health and how often you get flares.

Everyone in the study will get a Gout SMART app on their smartphone. If you're in the usual care group, your app will have information about gout and let you keep a diary of your gout attacks. Your regular doctor will handle your gout medication decisions. If you're in the Gout SMART group, you'll learn how to test your urate levels using a small hand-held device and strips. Your app will have all the features of the usual care app, plus a way to record your urate results. It will remind you to check your levels and tell you if you need to adjust your allopurinol dose, based on your individual plan. If you need to increase your dose, the app will remind you to re-check your levels two weeks later. The study will last for two years.

Potential risks and benefits

Participating in this study might offer benefits like potentially better control of your gout and fewer painful attacks if you're in the Gout SMART group. You'll also get a deeper understanding of your condition. However, there are no guarantees that you will personally benefit. Potential risks are generally low, but you might experience side effects from medication changes or find using the app and self-testing takes some time. Remember, your participation is completely voluntary, and you can withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • NHS Lothian
    Verified postcode
    Edinburgh, United Kingdom· Recruiting

Common questions

What is 'usual care' for gout?

Usual care means your regular doctor will manage your gout medication as they normally would, without using the special self-monitoring tools from the study.

What is a 'gout flare'?

A gout flare is a sudden, very painful attack in a joint, often feeling hot, swollen, and red.

Will I have to pay for the smartphone app or testing equipment?

No, all study-related equipment, including the app and finger-prick testing supplies, will be provided to you free of charge.

How often will I need to test my urate levels?

If you're in the Gout SMART group, the app will prompt you to check your urate levels regularly, especially when adjusting medication, but the exact frequency will depend on your personal treatment plan.

What if I don't have a smartphone?

To join this study, having a smartphone and being able to install and use the Gout SMART app is a requirement.

How to find out more

Philip L Riches, FRCP, PhD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Tight Control of Gouty Arthritis Compared to Usual Care…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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