Journal Article

Connecting real-world digital mobility assessment to clinical outcomes for regulatory and clinical endorsement–the Mobilise-D study protocol

Arnera, Valdo, Frei, Anja, Schwickert, Lars, Alcock, Lisa, Hopkinson, Nicholas S., Demeyer, Heleen, Rochester, Lynn, Caulfield, Brian, Chynkiamis, Nikolaos, Kirsten, Anne-Marie, Maetzler, Walter, Schlenstedt, Christian, Vogiatzis, Ioannis, Taraldsen, Kristin, Ammour, Nadir, Driss, Valérie, Polhemus, Ashley, Evers, Jordi, Ginis, Pieter, Mazzà, Claudia, Klucken, Jochen, Gimeno, Elena, Gaßner, Heiko, Puhan, Milo A., Hausdorff, Jeffrey M., Becker, Clemens, Mirelman, Anat, Comi, Giancarlo, Piraino, Paolo, Johnsen, Lars Gunnar, Winkler, Jürgen, Bosch de Basea, Magda, Buckley, Ellen, Helbostad, Jorunn L., Hume, Emily, Blain, Hubert, Singleton, David, Vereijken, Beatrix, Miller, Ram, Watz, Henrik, Megaritis, Dimitrios, Nieuwboer, Alice, Neatrour, Isabel, Gordon, Mark Forrest, Jansen, Carl-Philipp, Mikolaizak, A. Stefanie, Garcia-Aymerich, Judith, Buttery, Sara C., Yarnall, Alison J., Leocani, Letizia, Troosters, Thierry, Sharrack, Basil, Brittain, Gavin

2022

Overview

The development of optimal strategies to treat impaired mobility related to ageing and chronic disease requires better ways to detect and measure it. Digital health technology, including body worn sensors, has the potential to directly and accurately capture real-world mobility. Mobilise-D consists of 34 partners from 13 countries who are working together to jointly develop and implement a digital mobility assessment solution to demonstrate that real-world digital mobility outcomes have the potential to provide a better, safer, and quicker way to assess, monitor, and predict the efficacy of new interventions on impaired mobility. The overarching objective of the study is to establish the clinical validity of digital outcomes in patient populations impacted by mobility challenges, and to support engagement with regulatory and health technology agencies towards acceptance of digital mobility assessment in regulatory and health technology assessment decisions. The Mobilise-D clinical validation study is a longitudinal observational cohort study that will recruit 2400 participants from four clinical cohorts. The populations of the Innovative Medicine Initiative-Joint Undertaking represent neurodegenerative conditions (Parkinson's Disease), respiratory disease (Chronic Obstructive Pulmonary Disease), neuro-inflammatory disorder (Multiple Sclerosis), fall-related injuries, osteoporosis, sarcopenia, and frailty (Proximal Femoral Fracture). In total, 17 clinical sites in ten countries will recruit participants who will be evaluated every six months over a period of two years. A wide range of core and cohort specific outcome measures will be collected, spanning patient-reported, observer-reported, and clinician-reported outcomes as well as performance-based outcomes (physical measures and cognitive/mental measures). Daily-living mobility and physical capacity will be assessed directly using a wearable device. These four clinical cohorts were chosen to obtain generalizable clinical findings, including diverse clinical, cultural, geographical, and age representation. The disease cohorts include a broad and heterogeneous range of subject characteristics with varying chronic care needs, and represent different trajectories of mobility disability. The results of Mobilise-D will provide longitudinal data on the use of digital mobility outcomes to identify, stratify, and monitor disability. This will support the development of widespread, cost-effective access to optimal clinical mobility management through personalised healthcare. Further, Mobilise-D will provide evidence-based, direct measures which can be endorsed by regulatory agencies and health technology assessment bodies to quantify the impact of disease-modifying interventions on mobility. ISRCTN12051706.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Acceptance tests / Activities of daily living / Aging / Biology and Life Sciences / Chronic diseases / Chronic illnesses / Chronic obstructive pulmonary disease / Clinical outcomes / Cognitive ability / Cognitive science / Complications and side effects / Computer and Information Sciences / Computer Science / Consent / Digital health / Disability evaluation / E-health / Emerging Technologies / Evaluation / Frailty / Geriatry and gerontology / Health aspects / Health care / Human health and pathology / Humans / Inflammatory diseases / Life Sciences / Lung diseases / Medicine and Health Sciences / Mobility / Mobility management / Monitoring, Physiologic / Movement disorders / Multiple sclerosis / Neurodegenerative diseases / Neuroscience / Observational studies / Observational Studies as Topic / Obstructive lung disease / Osteoporosis / Parkinson Disease / Parkinson's disease / Patients / Physical Sciences / Physical Therapy Modalities / Physiological aspects / Populations / Pulmonary Disease, Chronic Obstructive / Pulmonology and respiratory tract / Questionnaires / Regulatory approval / Respiratory diseases / Sarcopenia / Study Protocol / Technology application / Technology assessment / Validation studies / Validity / Wearable technology