Deliverable D6.2 provides the study protocol V2.0 & participant information material for the clinical observational study (COS). As the study will be observational in nature and the focus is on identifying and evaluating digital parameters of fatigue, sleepiness and sleep disturbances in general, the consortium decided to rename the study “COS” to avoid the impression that the focus is on validating specific digital devices. The COS will follow 2,000 participants (500 subjects each for PD and IBD, 200 each for HD, RA, SLE, PSS and healthy controls). The study will run for 29 months, and each participant will be enrolled for a period of 24 weeks. During this time, each participant will attend two study visits at the recruitment centre (at week 0 and week 24 of their respective study period) as well as two remote visits in between (at week 8 and 16). During the visits, participants undergo a comprehensive assessment of demographic and clinical aspects as well as a granular assessment of fatigue, sleepiness and sleep disturbances using current reference tools (e.g. patient-reported outcomes, PROs). Furthermore, data on mood and pain are collected. Following each face-to-face / remote visit, participants use a combination of digital health technologies in their own environment for one week each. This is designated the technology use period (TUP). We selected two digital health technologies (and an additional one on an optional basis) based on the results of the Feasibility Study (FS), feature engineering exercises, analyses of relevant extant datasets and a literature review. Concomitant data on fatigue, sleep, selected ADLs and other confounding variables, together with other relevant contextual information will be collected remotely up to three times a day during the period of digital health technology use with Apps. The inclusion of two remote visits will enable us to collect data on acceptability, feasibility and operational challenges of the future use of these digital endpoints in a remote decentralised setting, and permits direct comparison of data quality and patient compliance in a remote study versus a clinical study. As far as possible in the framework of an observational study, blood, urine and stool samples will be collected for biobanking. Our cohorts will be drawn from 17 centres across 10 countries within Europe, representing geographic, ethnic and healthcare diversity.
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