Mobilise-D Technical Validation Study
Back in October 2020, the Mobilise-D Technical Validation Study (TVS) featured as a National Institute for Health Research (NIHR) case study for research restart (www.local.nihr.ac.uk/news/moving-research-forward-remotely/25810). The TVS is an international multi-centre observational study recruiting participants to six cohorts (Chronic Obstructive Pulmonary Disease, Parkinson’s disease, Multiple Sclerosis, patients who have sustained a Proximal femoral fracture, Congestive Heart Failure, as well as healthy older adults) across 5 sites from the UK, Germany and Israel. Despite the challenges due the pandemic, remarkably 65% of the planned sample (n=120) have been recruited to date, with recruitment to two patient cohorts complete, and recruitment to the other cohorts expected to be complete in the coming months.
Four months on and with the roll out of the COVID-19 vaccine, we are optimistically looking forward to starting the next stage of the Mobilise-D project – the Clinical Validation Study (CVS). Preparations including securing regulatory and governance approvals, as well as remote training though a series of virtual webinars are already well underway. The CVS will recruit 2,400 people across 17 clinical sites in Europe.
In Newcastle, the study is sponsored by the Newcastle upon Tyne NHS Foundation Trust and will take place at the Clinical Ageing Research Unit; an NIHR Clinical Research Facility based at the Campus for Ageing and Vitality, Newcastle University. Participants will be assessed five times over 2 years to validate digital mobility outcome measures to monitor changes in each condition and predict adverse clinical events (such as falls, functional deterioration and admission to a care facility). The overall aim of this study is to validate a new method to remotely measure and monitor changes in mobility in the real-world using low cost digital (wearable) devices.
The information gained will be used to support a case for regulatory approval for use of digital mobility outcomes in clinical research and healthcare. The Mobilise-D Consortium is a Public-Private Partnership funded by the European Innovative Medicines Initiative (IMI) and is led by Chief Investigator Professor Lynn Rochester.
For more information please see www.mobilise-d.eu/.