Moving Research Forward Remotely
Being able to remotely monitor a patient's mobility in their natural environment is a major advantage, especially within a lockdown situation.
This is the focus of the Mobilise-D Consortium, a Public-Private Partnership funded by the European Innovative Medicines Initiative (IMI) 2 Joint Undertaking, which includes 34 international research partners from academia and industry.
Professor Lynn Rochester at Newcastle University, leads the Mobilise-D Consortium alongside Dr Ronenn Roubenoff from Novartis. Professor Rochester is the Chief Investigator for the Mobilise-D Technical Validation Study (TVS) which was due to begin in early April but had to be postponed due to the pandemic.
TVS is an international multi-centre observational study involving 5 sites in the UK, Germany and Israel. Collectively, 120 participants will be enrolled with a range of health conditions (chronic obstructive pulmonary disease, Parkinson’s disease, multiple sclerosis, congestive heart failure and hip fracture) along with older adults.
In Newcastle, the study takes place at the Clinical Ageing Research Unit (CARU), an NIHR Clinical Research Facility based at the Campus for Ageing and Vitality, Newcastle University. The team from the Brain and Movement Research group and CARU have been investigating how they can work around new distancing restrictions to open the study.
In Newcastle, the study takes place at the Clinical Ageing Research Unit (CARU), an NIHR Clinical Research Facility based at the Campus for Ageing and Vitality, Newcastle University. The NIHR Newcastle Biomedical Research Centre (BRC) underpinned some investment in the project through ageing research, and studies involving Prof. Rochester. The team from the Brain and Movement Research group and CARU have been investigating how they can work around new distancing restrictions to open the study.
Professor Rochester explains, “This study involves participants coming into CARU and researchers visiting participants in their homes. We have to apply sensors to patients which involves a lot of patient interaction that we can’t avoid and as such we are taking all necessary precautions. We’ve had to carry out multiple risk assessments to make the lab visits and home follow-ups safe for all involved.
“I’m absolutely delighted the study sponsor (The Newcastle upon Tyne Hospitals NHS Foundation Trust) has worked with me and the team to get this complex, technical study started. It has been the continued communication between myself, CARU and the sponsor that has made this possible.
“The mobility measurement we’re focused on uses a single wearable device for seven days to remotely monitor people’s movement. By being able to accurately capture digital mobility outcomes, such as real world walking speed, it gives us an important insight into their healthcare condition, future needs and also how effectively interventions are working, which are of interest to pharmaceutical companies, as well as clinically.”
The study is the first critical phase of the work of the consortium and aims to demonstrate the validity of a wearable device to accurately measure a range of mobility outcomes collected continuously in the real-world. It also informs a second far larger Clinical Validation study of 2,400 participants over 16 sites, due to start in 2021.
Due to the pandemic, there is now an urgent need for remote monitoring studies and digital biomarker outcomes reflecting mobility.
Dr Ronenn Roubenoff (Novartis) adds, “The COVID-19 lockdown has shown us all not to take mobility for granted. For companies that sponsor research into new drugs, measuring mobility offers a new way of showing whether the medicines are working or not. It’s not something we could really assess before, or only on a very limited basis. But we must have a clear understanding that methods of measuring mobility are accurate and relate to medical outcomes – that’s why Mobilise-D is so important, especially now.”
Prof Rochester adds “The sort of technology we’re looking to validate could mean geographical barriers to taking part in research are removed, ensuring we have greater inclusivity in research studies so anyone, no matter where they live, could take part in research.”
The gait lab at CARU is equipped with state of the art movement analysis equipment which is essential for the technical nature of this validation study. The lab has remained open throughout the pandemic, giving the study team an advantage when it comes to implementing social and professional distancing procedures.
Dr Lisa Alcock, Research Associate and Gait Lab Manager, oversaw how the unit could comply with new COVID-19 rules and helped put infrastructure in place. “Our reception area is regularly cleaned, and participants aren’t waiting in that area for long, so there’s less chance of interaction with other people,” explains Dr Alcock.
“The size of the gait lab means we can easily adhere to the two metre distance. For procedures that require researchers to be within two metres of participants such as attaching sensors, full PPE is worn. The assessment area and sensors are cleaned and disinfected before and after each use. We’re also asking participants to attend CARU alone to minimise footfall and help with the flow of people through the unit. We’re taking all the necessary precautions to ensure participant and staff safety.”
Utilising redeployment experiences
The team at Newcastle have shared their updated risk assessments with all sites involved in the study, for both the lab assessments and home visits. Restrictions have meant assessments in participants’ houses have had to be scaled back for both staff and patients’ safety.
For one member of the team, being redeployed into the community as a physiotherapist provided valuable experience and insight into how follow-up home visits could be carried out.
“I became familiar with all of the PPE procedures when entering people’s houses, which put me in a good position for when the study started again.” explains research physiotherapist Philip Brown.
“We’ve had to make procedural adaptations to achieve our aims, but our specific roles within the TVS study haven’t changed because of COVID-19. Through more frequent telephone or email contact with participants ahead of visits, we’re able to give them more reassurance about their appointments.”
“They’re happy to come to a purely research focused clinical facility (not hospital based). They feel assured they’re in a safe environment and that the correct measures have been implemented to ensure their safety.”
“We represent the NHS, Newcastle University and the NIHR, and the reputation with that is very safe and positive. People are trusting of these organisations. People are keen to get involved in research again - which is a really positive thing for us.”
One of the studies first participants explained: “What could have been a stressful visit was alleviated by the precautions taken by everyone. It really highlighted that as an NHS institution, [the CARU] valued protecting me as well as colleagues by the use of PPE, social distancing and staggering of visiting times to ensure minimal contact with others.”
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