Work Packages

WP1 dealt with overall Project Coordination, Project Management, Financial Management, and Risk Management.

In addition, it focused on the development of strategies and long-term project plans, and ensured that work complied with national and EU Health and Safety regulations and Ethical Guidelines.

• Established management committees and guidelines for their operation
• Established technical and financial reporting guidelines, monitoring, and reporting
• Administered the Consortium Agreement
• Delivered all necessary reports, including periodic and final project reports

WP2 produced a validated ‘device-algorithm pair’ and associated technical, clinical, and patient-specific standards for clinical validation in WP4.

A comprehensive approach was adopted to achieve robust technical validation, including validation on real-world data. The current state-of-the-art modelling of human gait was combined with advanced processing techniques to increase the specificity and accuracy of algorithms. A range of human factors related to sensor and protocol acceptability were assessed.

• Created a database of existing real-world and laboratory data and algorithms for the quantification of digital mobility outcomes
• Optimized algorithms for digital mobility outcomes and confounding factors from different mobility sensors and locations
• Provided a validated device-algorithm pair to be used in WP4
• Assessed additional factors, such as user characteristics and comfort, wearability, and protocol acceptability, for the chosen mobility sensor solution
• Provided protocols, standards, manuals, technical validation datasets, sensor requirements, and algorithm specifications

WP3 was responsible for the design and implementation of the end-to-end data storage and management platform.

It primarily underpinned and enabled the activities of WP2 and WP4, as the principal aim of WP3 was to provide a facility for managing and storing the data generated during these WPs.

• Defined and implemented the standard for clinical and technical data acquisition, anonymization, quality check, and processing
• Specified and developed the end-to-end multimodal data hosting, management, and maintenance platform
• Implemented and tested the database management and data processing platform
• Provided a data management platform that met the specific needs for data security, privacy, and secure data transfer
• Produced and maintained the suite of software tools required for successful data capture in WP4

WP4 carried out the clinical validation where digital mobility outcomes were linked to clinical end-points. This was achieved through the Mobilise-D prospective longitudinal cohort study that incorporated four disease cohorts: chronic obstructive pulmonary disease (COPD), Parkinson’s disease (PD), multiple sclerosis (MS), and proximal femoral fracture (PFF).

Digital mobility outcomes were tested as predictors of mobility, disability, falls, hospitalization, nursing home admission, and mortality.

• Finalized the network of disease cohorts for recruitment into the Mobilise-D cohort study
• Refined the clinical assessment protocol for each disease cohort and the harmonized protocol for the Mobilise-D cohort
• Completed recruitment and longitudinal data collection in the prospective Mobilise-D cohort study
• Established the clinical validity of digital mobility outcomes to predict clinical end-points in each disease cohort and the global Mobilise-D cohort
• Provided clinical expertise in the planning of data analysis and data interpretation
• Produced and maintained the suite of software tools required for successful data capture in WP4

WP5 aimed 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 clinical practice as a technology to support medical decision-making and the management of individual patients.

• Pursued regulatory qualification of Digital Mobility Outcomes obtained with wearable sensors with the competent authorities (e.g., the European Medicines Agency in Europe, the Food & Drugs Administration in the USA) for use in the regulatory evaluation of new drugs.
• Engaged with national and European authorities to demonstrate how the use of digital mobility outcomes could help to better evaluate the socioeconomic impact of new drugs.

WP6 analyzed and validated digital mobility outcomes for the disease cohorts assessed and followed in WP4, with the aim of providing complete information for regulatory qualification.

The validation covered construct validity, predictive capacity, responsiveness, ability to detect changes, and the identification of a minimal important difference for improvement or worsening of the digital mobility outcomes.

• Studied the statistical distribution of digital mobility outcomes, clinical outcomes included in WP4 cohorts as primary or secondary outcome measures.
• Tested the construct validity of the digital mobility outcomes derived from the MOBILISE-D algorithms in large samples of patients with COPD, MS, PD, and PFF assessed under real-life conditions in WP4.
• Assessed the predictive capacity and thresholds of digital mobility outcomes for predicting clinical outcomes in prospective cohorts of patients with COPD, MS, PD, and PFF assessed under real-life conditions.
• Assessed responsiveness to potential interventions, ability to detect changes, and defined minimal important difference (MID) in digital mobility outcomes in patients with COPD, MS, PD, and PFF.
• Characterized real-world walking behaviour in patients with COPD, MS, PD, and PFF.

WP7 aimed 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, procedures were created and implemented to make data, standards, and software openly accessible.

To ensure sustainability after the life of the project, a digital mobility assessment module was developed and provided that enabled external researchers and industry to include real-world mobility assessment in future studies and trials.

• Drove public awareness of the Mobilise-D project by disseminating, teaching, and spreading the outcomes and results of the project
• Engaged the community and created a project Stakeholders Network
• Organized and participated in events to inform the relevant stakeholders and the public at large about project results and outcomes
• Created procedures to make data, standards, and software openly accessible
• Developed a strategy for the exploitation and translation of project results into practice
• Ensured optimal exploitation and sustainability by providing user-friendly mobility assessment modules