All the constraints of the past year, the recurrent lockdowns, all the additional challenges we faced having to change our homes to home-offices and home-schooling, could easily have stopped us from our endeavour, but no! We managed to find our way and continue our research, our testing, and our engagement with patients. We invited one of our Mobilisers working in WP2 Algorithm Development and Technical Validation, Kirsty Scott, to share some of the daunting yet exciting experiences of being part of the team and how they are managing to conduct the Technical Validation Study (TVS) in Mobilise-D in COVID-19 times.
Kirsty Scott is a PhD student at the University of Sheffield with scholarship funded by Grunenthal aiming to support the Mobilise-D project TVS, under the supervision of Prof. Claudia Mazzà, the WP2 academic lead. Kirsty works as part of the Mobilise-D team that is responsible for the development and training of the technical validation study that is currently being completed by WP2. Reflecting on her experiences and challenges faced while implementing a study in the middle of the COVID-19 pandemic, Kirsty is sharing the story of herself and colleague Stefano Bertuletti, a Post-Doc from the University of Sassari, as an insight into the work carried out by the WP2 team in preparing for this study.
“The year 2020 started off optimistically. After a successful 3-day meeting in January to finalise the protocol, plans were taking form to complete on-site training at each of the labs involved: Sheffield, Newcastle, Kiel, Stuttgart, and Tel Aviv. Five cities in three countries. And within a three-week window, Stefano and I were to visit all of them.”

“The Mobilise-D tour, as we decided to call the trip, started off well and the WP2 team were feeling confident! Training was successfully completed at our UK sites, and looming menace of COVID-19 was still nothing more than “something occurring on the other side of the world”. But after a short respite in Sheffield before travelling to our German partners, the conversation was slowly changing, with measures to wash hands regularly and keep social distance now in place. By the time we had finished our visit to Kiel and were flying to Stuttgart, the news came that this was now to be considered a pandemic. Things changed. And quickly. On arriving in Stuttgart, we were informed that we might not even be able to visit the lab and that the tour might have to be called off. After our first experience of receiving a COVID-19 test, and me doing my best at speaking broken German to the administering nurse, we were able to finish the training in Stuttgart, but that would be the end of the Mobilise-D tour. With growing concerns on travel, it was uncertain how and if we would manage to get home before things escalated. For the moment, Stefano and I would have to make the most of spending a few extra nights in Stuttgart (primarily taking advantage of the German beer and schnitzel). Finally, we managed to organise our flights.”

“Now that we were home, the question on everyone’s lips was “how do we finish the training and preparation for the study?” and more importantly “when will the study even start?” With what was a very uncertain time, preparation for this study was crucial. As lockdowns across the globe were being put in place, it was a rush to get everything sorted. Our spare cupboards in our flats became depots for Mobilise-D as we worked to ship everything and ensure each site was prepared for the (possibly delayed) start of April 2020.”
“The WP leads worked tirelessly to develop a contingency plan and after an hours-long debriefing, it was the news that we had hoped for. The study would continue, albeit later in the year. The revised start date would now be at the end of the summer of 2020. At a time where there was so much uncertainty as to how this pandemic would affect us on a personal and project level, this was the news that we needed.”
“As the lockdowns in each of the site locations continued, access to labs and offices was completely blocked. Now that we knew this study would continue, we had to adapt our support to virtual and with limited access to our regular workspace, we had to learn to work from home.”
“With such a detailed technical protocol, what was an already challenging study became even more difficult. We had to understand the experience and additional requirements for each site, without having access to, or seeing them, and we had to add the risk assessment for the study in COVID-19 times. Despite the difficulty and the new work situation, what came about was a strong feeling of solidarity and collaboration. Instead of on-site trainings, training manuals were written up covering every detail of the study, online training resources were made available to each of the sites. Even our unsuspecting family members were not spared: they became the test-patients for our test runs at home. On the bright side, it was nice to finally have my family understand what my PhD and research was about!”
“As the summer of 2020 ended, the labs started to open again with new health and safety regulations in response to COVID-19. Although we still could not travel, virtual run throughs of the protocol took the place of on-site supervision, and together with the lab-sites, we managed to refine all the details for the study. And finally. Finally, the study could start, and testing could begin! Our first patient in was on August 21. There was a lot of anticipation to see if all the planning (and the frayed nerves) would pay off, and although there were some minor hiccups, we were up and running!”
The study is now running across all five labs (Sheffield, Newcastle, Kiel, Stuttgart, and Tel Aviv) with participant and researcher safety being our core focus and subsequently strict Covid-19 regulations in place at each of our sites. Recruitment is well underway, with 78 participants now successfully completed the study, 2 in progress and 2 scheduled to participate when writing this article. Our aim is to have 120 participants complete this study, with 20 for each cohort: healthy older adults, Parkinson’s Disease (PD), Multiple Sclerosis (MS), Chronic Obstructive Pulmonary Disease (COPD), Congestive Heart Failure (CHF) and Proximal Femoral Fracture (PFF). We have now completed data collection for our healthy adults and PD cohort and are over 75% of the way there for our MS and PFF cohort. However, given the vulnerability of the COPD and CHF cohort in the COVID-19 pandemic, we are sitting at under 50% recruitment. On the bright side, recruitment is now starting to improve for our last two cohorts with the implementation of the COVID-19 vaccinations.”
“If nothing else, the COVID-19 pandemic has highlighted the importance of the work we are doing as part of Mobilise-D. The ability to remotely assess patients is crucial in the future development of healthcare.”
“From a personal perspective, this experience has been a challenging yet rewarding one. I have worked with people that I have never or rarely met to develop a study remotely. Our constant communication and ability to adapt has proven to be a success, and that is something I will continue to take forward through the rest of my PhD and role in Mobilise-D.”
“Although the challenges may not be over (with the everchanging lockdown status) I believe that with everything we have managed to overcome we will be successful in finishing this study and completing a major milestone in the Mobilise-D project.”
“I look forward to when the WP2 team can meet in person to celebrate this accomplishment together.”