In Period 1 (P1), IDEA-FAST conducted a Feasibility Study (FS) to: (i) identify the most promising digital measures of fatigue and sleep; (ii) test the feasibility, acceptability and utility of the various digital technologies for profiling sleep, fatigue and ADLs in the various patient populations. The FS study protocol was co-developed with patients, and regulatory approvals were obtained. A first version of the Data Management Platform (DMP) was developed and released which included Access Control and data provenance mechanisms for compliance with legal & data privacy requirements, and to ensure data integrity and security. The assessment protocol for candidate digital endpoints of fatigue and sleep problems in NDD and IMID was prepared. A regulatory strategy was developed and discussed with the EMA Innovation Task Force. The consortium governance structure and various advisory boards were established. A project website and social media platforms were created.
In P2, IDEA-FAST completed the FS plus a supplementary polysomnography (PSG) sub-study. The 2 multi-modal datasets were among the largest datasets worldwide with such comprehensive study design. The data was analysed to identify candidate digital endpoints and their variability in the home environment. The results supported the development of the study protocol for the Clinical Observational Study (COS) which received regulatory approvals. In preparation for the participant recruitment to the COS, a strategy for procurement and distribution of digital technology to 22 study sites across 10 European countries was developed. Work was also undertaken to map potential exploitable assets generated within IDEA-FAST. In addition, the project disseminated to its stakeholders through the website, LinkedIn and X as well as via peer reviewed publications and presentations.
In P3, IDEA-FAST initiated recruitment to the COS, with nearly 500 participants recruited. To increase the impact of the FS, we performed additional analyses of the FS data and disseminated the results at appropriate conferences and in peer-reviewed scientific journals. With extensive patient and public engagement, we developed a new mobile application and improved an existing mobile application to capture socialisation and neurocognitive data, respectively. To support the data collection and management, a clinical database was developed, the DMP was further refined, and a data transfer and integration pipeline was established between the two platforms.
In P4, IDEA-FAST continued recruitment to the COS and various mitigation actions were implemented to overcome delays due to COVID. Effort was focused on ensuring the quality, completeness and standardisation of the COS data being collected. The COS Statistical Analysis Plan (SAP) was generated. An Analytical Environment for the DMP was developed and several data analytics pipelines have been deployed. A 12-month project extension was requested and granted. Two new partners (Bristol-Myers-Scribbs (EFPIA) and University College Cork (academic) have joined the consortium.
In P5, IDEA-FAST continued recruitment to the COS with 1,700 participants (out of a target of 2,000) recruited. Significant data analysis has been undertaken including feature extraction and performance assessment of candidate device-specific digital endpoints. The DMP was further refined. Work on the data governance strategy has continued in light of the upcoming EHDS regulations. An interim exploitation plan was produced.
