Information for Participants
Gout is the most prevalent inflammatory arthritis, affecting 2.5% of adults in the UK, and causes significant pain, disability and impaired health-related quality of life.
It is largely managed in primary care, where gout flares are most frequently treated with NSAIDs. However, many people are unable to take NSAIDs due to older age, chronic kidney disease and cardiovascular diseases.
When gout flares occur in people who are unable to take NSAIDs, alternative treatments, such as colchicine and steroids, are needed.
This trial will therefore help improve understanding of these treatments, improving the care of patients with gout and help to inform healthcare professionals on the best treatment for gout for people who are unable to take NSAIDs.
Gout Affects
2.5% of the
UK Population
You will also be asked to complete a questionnaire before you start your treatment, a diary for the first 7 days and follow-up questionnaires at 2, 3 and 4 weeks. This is so we can find out if your symptoms change following treatment and how long any changes last for.
The participant information sheet for the OCCUR trial, containing more information about the trial and what’s involved with taking part can be found by clicking on one of the following links:
If you would prefer to watch a short animated version of the participant information sheet, please see below:
The OCCUR trial plans to work with approximately 100 GP practices across the UK to recruit 280 participants over a 2 year period. Participants will be followed up for 4 weeks to find out how the medication has helped to manage their symptoms.
100 GP Practices
280 Participants
2 Year Period
People registered with participating GP practices who are aged 18 years or over with gout symptoms who are unable to take NSAID’s will be eligible to take part.
If you decide to take part in the OCCUR trial you will first need to give your consent to take part in the trial. You may find the following animation useful which explains more about why we need your consent:
Click on Consent below and select the language you prefer.
Consent
Informed Consent Animation in English
Informed Consent Animation in English with BSL
Informed Consent Animation in Punjabi
Informed Consent Animation in Polish
Informed Consent Animation in Romanian
If you are happy to give consent to take part in the trial and are eligible to take part, you will be randomly allocated to receive either colchicine or prednisolone which your GP will prescribe to manage your gout flare symptoms. Which treatment you receive will be decided at random, the following animation explains the process of randomisation and how it ensures a fair comparison of both treatments:
Click on Randomisation below and select the language you prefer.
Randomisation
Randomisation Animation in English
Randomisation Animation in English with BSL
Randomisation Animation in Punjabi
Randomisation Animation in Polish
Randomisation Animation in Romanian
Being involved in the trial requires your time and commitment to complete the diary and questionnaires.
All medications can potentially cause side effects. Steroid tablets and colchicine have both been used to treat gout flares in the UK for many years. Your GP will assess whether or not it is safe for you to have steroid tablets or colchicine before you enter the trial. Whilst you are participating in this trial, your safety is paramount, you may find the following animation useful in explaining what steps we take to ensure your safety:
Click on Safety below to select the language you prefer.
Safety
Safety Animation in English
Safety Animation in English with BSL
Safety Animation in Punjabi
Safety Animation in Polish
Safety Animation in Romanian
The OCCUR trial is being led by the Chief Investigator, Professor Mark Lambie and other researchers at Keele University, the University of Nottingham, University of Southampton and Midlands Partnership University NHS Foundation Trust in collaboration with a number of GP practices and is sponsored by Keele University.
It is funded by the National Institute for Health and Care Research (NIHR): Health Technology Assessment (ref: NIHR160813).
All research carried out within the NHS is assessed by an independent group of people, called a Research Ethics Committee, to protect your safety, rights, well-being and dignity. OCCUR has been reviewed and given a favourable opinion by West Midlands – Coventry & Warwickshire Research Ethics Committee, ref: 25/WM/0121.
As patients will be randomly allocated to one of the two medicines used in this trial, OCCUR has also been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA), who ensure that medicines work and are acceptably safe.
If you would like to find out more about the trial, please contact the OCCUR trial team either by telephone, email or via social media on the details below:
01782 732950
How will I know if I’m eligible to take part?
If you are potentially eligible to take part you will be sent an invitation from your GP practice. Alternatively, mention your interest to your GP during your appointment.
Will I be reimbursed for travel to my GP appointment?
Unfortunately, we cannot reimburse you for travel and car parking costs that you may have to pay for attending GP appointments.
Will I be reimbursed for my prescription costs?
If you do normally pay for your prescription, we are able to reimburse this cost to you, please keep your receipt/proof of payment.
How will I find out about the results of the trial?
After the trial has finished and we have looked at the results, the data, when made anonymous, will be published in medical journals, and we will also present the findings at medical or scientific conferences. A summary of the results will also be available on this website.
What if I change my mind about taking part?
Even if you agree to take part and have given your consent, you are still free to withdraw at any time without giving a reason and your ongoing care will not be affected in any way. You can do this by contacting Keele CTU by phoning 01782 732950 or sending an email to ctu.occur@keele.ac.uk.
Can I choose which medication I am prescribed in the trial?
A computer programme will be used to randomly allocate you to receive either steroid tablets (prednisolone) or colchicine tablets. There will be an equal chance of you being allocated to receive either medication. Randomisation helps to ensure that any differences in outcomes are due to the treatment you are allocated and not other factors. This means that randomised controlled trials can show the effectiveness of different types of treatments.
How long will I be involved in the trial for?
Being involved in the trial requires your time and commitment to complete the OCCUR diary (twice daily for 7 days after your appointment) and completing 4 questionnaires (one before your appointment with your GP (or other healthcare professional at your practice) and further questionnaires 2, 3 and 4 weeks after your appointment).
Who can I talk to if I have any questions about the trial?
If you have any questions, would like any further information please contact the OCCUR trial team at Keele CTU by phoning 01782 732950 or sending an email to ctu.occur@keele.ac.uk.
