Monitoring patients’ mobility during the COVID19 pandemic could easily have been impossible due to lockdown and restrictions such as social distancing. However, this isn’t the case for the Mobilise-D technical validation study (TVS) where 120 participants with chronic obstructive pulmonary disease, Parkinson’s disease, multiple sclerosis, congestive heart failure or hip fracture, along with healthy older adults, will be enrolled. Our test sites in Newcastle and Sheffield have found a way to work around the distancing restrictions to keep the study open, and confirmed that the technical validation study testing will continue despite the 2nd lockdown in the UK.
The TVS plays a central role for the progress in the Mobilise-D consortium and is a prerequisite for the larger clinical validation study that is due to start in April 2021. The aim is to demonstrate the validity of a wearable device to accurately measure a range of mobility outcomes collected continuously in the real world. The TVS was scheduled to start in early April this year but had to be postponed due to the pandemic. Against the odds, and despite patient proximity when attaching sensors, the TVS received green light to commence recruitment this summer. -How was this made possible during national lockdown and social distancing restrictions?
Our TVS team in Newcastle investigated how they could work around the distancing restrictions to open the study and did multiple risk assessments to ensure participant and staff safety. Then they shared their updated risk assessments with all 5 sites involved in the study in the UK, Germany and Israel, for both lab assessments and home visits. First, professional distancing procedures had to be developed to avoid interaction– such as adhering to the two-meter distance and minimizing waiting time in the reception area before the lab assessment. For lab procedures and home visits that require researchers to be within two meters of participants, such as attaching sensors, full personal protective equipment (PPE) is worn. Ahead of visits, more frequent telephone or email contact with participants gives them additional reassurance about their appointments. Second, the assessment area and sensors are cleaned and disinfected both before and after each use, as well as the reception area. These precautions have made study participants safer, and one of the first participants said:
“What could have been a stressful visit was alleviated by the precautions taken by everyone. It really highlighted that as an NHS institution, [the Clinical Ageing Research Unit, 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.”
Thanks to the commitment of all 5 TVS test sites, we have now recruited 1/3 of the participants, and the aim is to reach at least 60% by the end of the year, with plans to finish by March 2021.
Recently, the National Institute for Health Research (NIHR), UK, featured Mobilise-D as a case study for how to start research in a global pandemic. You can read their article here.