Please note - the VROOM study is now closed to recruitment.
What will happen if I choose to take part?
The care you currently receive for your condition will not change. However we will ask you to come to your local hospital (care centre) three additional times for the VROOM study. We are able to cover your travel cost travel for these visits.
On the first visit, which must be before you receive your COVID-19 booster vaccination, you will be asked to give your consent to take part in the VROOM study, give a small blood sample (7ml – the equivalent of just over a teaspoonful) and answer a short questionnaire.
You will then be asked to contact the research team once you have a date for your COVID-19 booster vaccination – the study team (if you agree) will contact you once a week either by text, email or by telephone to see if you have received a date. The study team/study database will then ask you a few brief questions and, provided you are willing to continue with the study, advise you to either continue methotrexate treatment as usual or to skip taking methotrexate for two weeks from the date of the booster vaccination.
The decision on who is advised to interrupt treatment and who is advised to continue treatment will be made by a computer programme and is similar to rolling a dice. The study team member has no control on who is advised to continue or interrupt methotrexate treatment.
After your booster, depending on your preferences, we will then send you up to six texts in the two weeks around your vaccination to remind you which group you were put into and to find out how you are and what methotrexate you have taken over the 2 weeks. If you don’t want to be texted, then a member of the study team can call you, or send you short emails.
Just before four and 12 weeks from your booster vaccination date we will send you the questionnaires about your health and wellbeing that you will be asked to complete when you visit the hospital either by email or by post if you like to. Alternatively, when you come back to the hospital the questionnaire can be given to you to fill in and a small blood sample (7ml – the equivalent of just over a teaspoonful) taken. We anticipate that each of these visits should take approximately 20 minutes. This will then end your participation in the study.
We will ask your permission for your blood samples to be used for the VROOM study, and if any part of the samples are left over at the end of the study, we will ask your permission to put them into a bank of samples that other researchers might wish to access for other ethically approved studies. Researchers who accessed the samples would not be given any of your details they would only know the samples were from someone with an inflammatory condition who took part in the VROOM study.
When, where and which COVID-19 booster vaccination you are offered/receive will not be affected whether you decide to take part in the VROOM study or not.
Note: You should only stop taking medications prescribed by a doctor after talking to them – if you are suitable for this study and decide to take part, you will only be entered if your hospital medical team have no objections to you temporarily stopping taking your methotrexate for two weeks.
What are the risks and benefits to taking part in this study?
We hope that the valuable information from this study will give the NHS and other countries a clear answer to the question of whether temporarily stopping methotrexate for two weeks around the time of COVID-19 booster vaccination improves the vaccine response. We cannot promise that the study will help you directly, but the information we receive has the potential to benefit all those with inflammatory conditions who continue to be vaccinated against COVID-19 in the future. Thus, the results of this study may benefit you in the future.
There is a small risk of your condition flaring up on interrupting methotrexate treatment for two weeks. However, you will be able to access treatment for flare-up as usual.
People sometimes feel uncomfortable answering certain questions about their health, or may feel unable to answer certain questions. If you feel uncomfortable at any point, then you do not have to answer the questions.
What will happen at the end of the study?
At the end of the study, we will send you a copy of the results of the study if you wish and also what the results were of any of the blood tests that we conducted on your samples. There will also be a letter to explain what the results might mean and what the range of the results were in those taking part so you could see how your results compared to others taking part in the study. You will get your sample results but, other than what the result ranges for other people taking part were, no-one will be identified to you or anyone else outside the VROOM study team.
What should I do if I would like to find out more or take part in the study?
If after reading this website you think you might like to take part in the study - then click on the sites tab to find out if the hospital that you usually attend for your dermatology or rheumatology care is taking part. Unfortunately at the moment we can only recruit individuals who usually receive care at the hospitals listed. If your hospital is listed then you can either get in contact with your clinical team or contact the VROOM team to let us know you are interested in taking part on email@example.com or by calling 0808 196 2101.