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Case Study: How Claire helped bring research studies to potentially at-risk patients in the South West during a pandemic

Case Study: How Claire helped bring research studies to potentially at-risk patients in the South West during a pandemic

It’s been nearly a year since Claire Bewshea’s work and personal life were impacted by COVID-19. As the Project Manager of  a major UK study investigating whether patients with Inflammatory Bowel Disease (IBD) are at an increased risk of COVID-19, called the CLARITY Study, Claire has had to think outside of the box to bring research to at-risk patients, all whilst dealing with the physical ongoing effects of long COVID.

The CLARITY Study is being run by the IBD research team at the Royal Devon and Exeter NHS Foundation Trust and the University of Exeter Medical School, supported by the NIHR Clinical Research Network in the South West.

The study, which Claire is project managing, is looking at the development of antibodies to SARS-CoV-2 (the virus that causes COVID-19) in UK patients with IBD – the umbrella term for Crohn’s Disease and Ulcerative Colitis. Researchers have been testing samples from approximately 15,000 patients collected since the start of 2020 for antibodies against SARS-CoV-2. At the same time the researchers are following almost 7,000 patients who are receiving infliximab or vedolizumab, testing for antibodies against the virus every 8 weeks

At the time the study started Claire herself was dealing with the after-effects of COVID-19 after falling ill with the virus in March 2020. She is still dealing with the effects of ‘post COVID-19 syndrome’, also known as ‘long COVID’ and so knows first-hand how debilitating the virus can be, especially for potentially vulnerable IBD patients.

“I came down with COVID on March 12th last year” she said. “I had breathlessness, and the first lockdown had just started so I had to cope with it at home. It was very scary at the time. I’m a single parent, and my daughter had it as well. I was paranoid of passing it on to anyone else whilst also dealing with terrible breathlessness.

“I’ve continued to experience the effects of long COVID, such as fatigue and constant muscle ache, which have added to the challenges of working on a demanding project. I experienced tachycardia and heart problems at a time when not a lot was known about long COVID, and many even questioned whether it existed.

“I just had to get on with it, drag myself out of bed and try and get on with my day. Doing a project such as CLARITY really helped with this as it meant I had to take a step forward every day and pull myself together.”

Claire’s work on the CLARITY Study began amidst these challenges.

“The thought process behind the CLARITY Study happened around June-July of last year. We wanted to do some research around Inflammatory Bowel Disease (IBD) and the effect of COVID-19 on IBD patients. IBD patients already have an impaired immune system, so are a very important group to look at. Our previous work in IBD research had enabled us to create a huge network of clinicians and research teams across around 140 hospitals in the UK.

“We wanted to use this resource to help people with IBD and the effect COVID-19 might be having on them. The majority would be shielding due to their compromised immune system. We wanted to find out whether it was safe for these patients to come out of isolation and better understand the effect of the biologic drugs they were taking for IBD on their immune systems.

“We didn’t want a study to put patients at any additional risk of exposure, so we planned the study entirely around existing appointments. IBD patients would come into hospital to receive regular infusions. By tapping into this existing appointment we could protect patients from any additional risk of exposure to COVID-19 and also make it as easy as possible for our healthcare sites to participate.”

The initial results of the CLARITY Study, have been released and will help inform public health policy decisions for people living with Crohn’s and Colitis, as well as millions of other UK patients treated with immunosuppressive drugs.

“It’s been incredibly busy. As a Project Manager you’re used to solving problems and trying to overcome hurdles, which is what we’ve been trying to do to make the study flow and make sure everyone can participate.

“COVID-19 has been my biggest challenge, as a project manager, to date. We recruited 7,000 patients in three months - it’s an incredible feat, which meant pulling out all the stops. I’ve had to plan very quickly, procuring consumables for blood and considering transportation which would be both easy to do and COVID secure. We’re a very small cohesive team, and everyone helped making up packs whilst dealing with new and unusual challenges; even having access to a suitable office space became a problem. I am very grateful that I work with such likeminded committed people.

“Next came the consideration of who will process our samples and store them. The Exeter Clinical Laboratory were a great help processing our samples, and we also had help from the NIHR Exeter Clinical Research Facility (CRF) in sourcing freezer space, which is in high demand due to the vaccines. Once our samples were processed we store them and make up three ‘aliquots’ (separating a larger sample into several parts by diluting it with inactive ingredients), resulting in our 7,000 samples becoming 21,000. These challenges were significant for such a small team, alongside the challenges of recruiting participants.

“I was really blown away by how everyone pushed themselves, working above and beyond to help us succeed. It’s been amazing how people have stepped in to help, especially the Exeter CRF and Exeter Clinical Laboratory.”

The CLARITY study is on-going, with the 7,000 participants taking part via their existing IBD infusion appointments over the course of 40 weeks. Claire and her team are continuing to have to adapt to change and continue to explore new ideas to keep participants safe throughout this process.

“To help keep patients safe and ensure they feel safe, we’ve adapted an existing system so that our 8-weekly questionnaire to participants can be sent by email or to their mobile phone and completed at home. We are also collecting information on vaccines now, adapting our database to ask patients whether they have received the vaccine and trying to keep the study as dynamic as possible.

“The challenge now is to keep the study going. Keeping participants in the study during lockdown was quite challenging as hospitals were overrun. Even getting a Research Nurse into an infusion clinic became more of a challenge, as the priority of the infusion nurses is understandably to keep everything secure for those patients. There were nurses travelling over 10 miles to visit infusion units, they have really gone way above their normal job roles.

“We’re increasingly thinking of ways this can be done at home, so we have been using a home blood collection kit developed by the Exeter Clinical Laboratory so that the sample can be taken at home. This comes with its own problems, as it is not easy to use, especially for patients with problems with their hands or frailty. Having these options will allow us to make blood collection as COVID-secure as possible.

“Everyone involved in the study has gone over and above. The research teams worked so hard to get 7,000 participants into the study in just under 12 weeks. It was an absolutely enormous feat. It has been an inspirational, incredible study to work on and amazing to see how far people will go to run studies like this. I’m very passionate about research, particularly in Exeter, and I’ve always been keen to continue putting Exeter on the map.

“We have really interesting data already which is really exciting and our first paper has been published in GUT, with a second vaccine paper due out this week, so watch this space.”

Inflammatory Bowel Disease (IBD) affects over 500,000 people across the UK. The main symptoms include urgent and frequent bloody diarrhoea, weight loss, severe pain, and extreme fatigue.

Visit the study website to view the results and visit the Twitter account @CLARITYIBD for the latest updates.

This study was supported by the NIHR CRN South West Peninsula Study Support Team. Find out how the Study Support Team can support you and your research.

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