Deliverable D6.1 describes the first version of the protocol for the clinical observational study (COS; formerly clinical validation study – CVS). As the study will be of observational 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 “clinical observational study” to avoid the impression that the focus is on validating specific digital devices. The COS will follow 2000 participants (500 subjects each for Parkinson’s Disease (PD) and Inflammatory bowel disease (IBD), 200 each for Huntington’s Disease (HD), Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Primary Sjögren’s Syndrome (PSS) and healthy controls) in four visits over six months each. Each participant will attend two study visits at the recruitment centres at Month 0 and Month 6 of the COS, as well as two remote visits in between. Following each visit, participants will use a combination of digital health technologies in their own environment for one week each. We selected seven digital health technologies based on the Feasibility Study (FS) results, 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 several times a day during the period of digital health technology use. The inclusion of two “remote visits” will enable us to collect data on acceptability, feasibility and operational challenges relating to the future use of these digital endpoints in a remote decentralised clinical trial setting, and will permit direct comparison of data quality, patient compliance and cost of a remote study versus a traditional clinical study. As far as possible in the framework of an observational study, a baseline blood test to screen for potential contributing factors of fatigue will be performed. We will also collect blood, urine and stool samples for biobanking (optional for participants, samples to be stored but not analysed in the context of this project). Our cohorts will be drawn from 22 centres across 10 countries within Europe, representing geographic, ethnic and healthcare diversity.
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