TY - JOUR
T1 - Connecting real-world digital mobility assessment to clinical outcomes for regulatory and clinical endorsement–the Mobilise-D study protocol
AU - Mikolaizak, A. Stefanie
AU - Rochester, Lynn
AU - Maetzler, Walter
AU - Sharrack, Basil
AU - Demeyer, Heleen
AU - Mazzà, Claudia
AU - Caulfield, Brian
AU - Garcia-Aymerich, Judith
AU - Vereijken, Beatrix
AU - Arnera, Valdo
AU - Miller, Ram
AU - Piraino, Paolo
AU - Ammour, Nadir
AU - Gordon, Mark Forrest
AU - Troosters, Thierry
AU - Yarnall, Alison J.
AU - Alcock, Lisa
AU - Gaßner, Heiko
AU - Winkler, Jürgen
AU - Klucken, Jochen
AU - Schlenstedt, Christian
AU - Watz, Henrik
AU - Kirsten, Anne-Marie
AU - Vogiatzis, Ioannis
AU - Chynkiamis, Nikolaos
AU - Hume, Emily
AU - Megaritis, Dimitrios
AU - Nieuwboer, Alice
AU - Ginis, Pieter
AU - Buckley, Ellen
AU - Brittain, Gavin
AU - Comi, Giancarlo
AU - Leocani, Letizia
AU - Helbostad, Jorunn L.
AU - Johnsen, Lars Gunnar
AU - Taraldsen, Kristin
AU - Blain, Hubert
AU - Driss, Valérie
AU - Frei, Anja
AU - Puhan, Milo A.
AU - Polhemus, Ashley
AU - Bosch de Basea, Magda
AU - Gimeno, Elena
AU - Hopkinson, Nicholas S.
AU - Buttery, Sara C.
AU - Hausdorff, Jeffrey M.
AU - Mirelman, Anat
AU - Evers, Jordi
AU - Neatrour, Isabel
AU - Singleton, David
AU - Schwickert, Lars
AU - Becker, Clemens
AU - Jansen, Carl-Philipp
AU - Mobilise-D consortium
N1 - Funding information: Full membership of the Mobilise-D consortium is available on the website https://www.mobilise-d.eu/partners. ISGlobal acknowledges support from the Spanish Ministry of Science, Innovation and Universities through the “Centro de Excelencia Severo Ochoa 2019–2023” Program (CEX2018-000806-S), and support from the Generalitat de Catalunya through the CERCA Program. Heleen Demeyer is a post-doctoral fellow of the FWO Flanders. Heiko Gaßner is supported by the Fraunhofer Internal Programs under Grant No. Attract 044–602140 and 044–602150.
PY - 2022/10/6
Y1 - 2022/10/6
N2 - Background: 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. Methods/design: 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. Discussion: 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. Trial registration: ISRCTN12051706.
AB - Background: 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. Methods/design: 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. Discussion: 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. Trial registration: ISRCTN12051706.
KW - Frailty
KW - Humans
KW - Monitoring, Physiologic
KW - Observational Studies as Topic
KW - Parkinson Disease
KW - Physical Therapy Modalities
KW - Pulmonary Disease, Chronic Obstructive
UR - http://www.scopus.com/inward/record.url?scp=85139376787&partnerID=8YFLogxK
U2 - 10.1371/journal.pone.0269615
DO - 10.1371/journal.pone.0269615
M3 - Article
C2 - 36201476
SN - 1932-6203
VL - 17
JO - PLoS One
JF - PLoS One
IS - 10
M1 - e0269615
ER -