WP1 deals with overall Project Coordination, Project Management, Financial Management, and Risk Management.
In addition, it focuses on development of strategies and long-term project plans, and ensures that work complies with national and EU Health and Safety regulations and Ethical Guidelines.
• Establish management committees and guidelines for their operation
• Establish technical and financial reporting guidelines, monitoring and reporting
• Administration of Consortium Agreement
• Delivery of all necessary reports including periodic and final project reports
WP2 will produce a validated ‘device-algorithm pair’ and associated technical, clinical and patient specific standards for clinical validation in WP4.
A comprehensive approach will be adopted to achieve a robust technical validation, including validation on real world data. Current state of the art modelling of human gait will be combined with advanced processing techniques to increase the specificity and accuracy of algorithms. A range of human factors will be assessed related to sensor and protocol acceptability.
• Create a database of existing real-world and laboratory data and algorithms for the quantification of digital mobility outcomes
• Optimise algorithms for digital mobility outcomes and confounding factors from different mobility sensors and locations
• Provide a validated device-algorithm pair to be used in WP4
• Assess additional factors, such as user characteristics and comfort, wearability and protocol acceptability, for the chosen mobility sensor solution
• Provide protocols, standards, manuals, technical validation datasets, sensor requirements and algorithm specifications
WP3 will be responsible for design and implementation of the end-to-end data storage and management platform.
It will primarily underpin and enable the activities of WP2 and WP4, as the principal aim of WP3 is to provide a facility for managing and storing the data generated during these WPs.
• Define and implement the standard for clinical and technical data acquisition, anonymisation, quality check and processing
• Specify and develop end-to-end multimodal data hosting, management and maintenance platform
• Implement and test the database management and data processing platform
• Provide a data management platform that meets the specific needs for data security, privacy and secure data transfer
• Produce and maintain the suite of software tools that are required for successful data capture in WP4
WP4 will carry out the clinical validation where digital mobility outcomes are linked to clinical end-points. This will be achieved through the Mobilise-D prospective longitudinal cohort study that incorporates four disease cohorts: chronic obstructive pulmonary disease (COPD), Parkinson’s disease (PD), multiple sclerosis (MS) and proximal femoral fracture (PFF).
Digital mobility outcomes will be tested as predictors of mobility, disability, falls, hospitalisation, nursing home admission and mortality.
• Finalise the network of disease cohorts for recruitment into the Mobilise-D cohort study
• Refine the clinical assessment protocol for each disease cohort and the harmonised
protocol for the Mobilise-D cohort
• Complete recruitment and longitudinal data collection in prospective Mobilise-D
cohort study
• Establish clinical validity of digital mobility outcomes to predict clinical end-points
in each disease cohort and the global Mobilise-D cohort
• Provide clinical expertise in the planning of data analysis and data interpretation
WP5 aims to foster acceptance by global health authorities, and health technology assessment bodies of the routine use of wearable mobility sensors in the safety and efficacy testing of new medicinal products, and in the clinical practice as a technology to support medical decision and management of individual patients
• Pursue with the competent authorities (e.g. the European Medicines Agency in Europe, the Food & Drugs Administration in USA) the regulatory qualification of Digital Mobility Outcomes obtained with wearable sensors for the use in the regulatory evaluation of new drugs.
• Engage with national and European authorities to demonstrate how the use of digital mobility outcomes can help to better evaluate the socioeconomic impact of new drugs.
WP6 will analyse and validate digital mobility outcomes for the disease cohorts assessed and followed in WP4, with the aim to provide complete information for regulatory qualification.
The validation will cover construct validity, predictive capacity, responsiveness, ability to detect changes and identify a minimal important difference for improvement or worsening of the digital mobility outcomes.
• Test construct validity of the digital mobility outcomes in large samples of patients with COPD, MS, PD and PFF assessed under real life conditions
• Assess predictive capacity and thresholds of digital mobility outcomes for prediction of clinical outcomes, in prospective cohorts of patients with COPD, MS, PD and PFF
• Assess responsiveness to potential interventions and ability to detect changes and define minimal important difference (MID) in digital mobility outcomes in patients with COPD, MS, PD and PFF
• Characterise real-world walking behaviour in patients with COPD, MS, PD and PFF
WP7s main goals are to drive public awareness of the project by disseminating, teaching, and spreading the outcomes and results of the project. To promote access and use of project results, we will create and implement procedures to make data, standards, and software openly accessible.
To ensure sustainability after the life of the project, a digital mobility assessment module will be developed and provided that will enable external researchers and industry to include real-world mobility assessment in future studies and trials.
• Drive public awareness of the Mobilise-D project by disseminating, teaching,
and spreading the outcomes and results of the project
• Engage the community and create a project Stakeholders Network
• Organise and participate in events to inform the relevant stakeholders and public
at large about project results and outcomes
• Create procedures to make data, standards, and software openly accessible
• Develop a strategy for exploitation and translation of project results into practice
• Ensure optimal exploitation and sustainability by providing user-friendly mobility
assessment modules
