The first study subject approvals package includes the final version of the feasibility study (FS) protocol, the registration number of the feasibility study as well as a short report on the ethical approval status at all four sites. Ethical approval was obtained at one of the four sites so far. As a result, the first subject was included in the IDEA-FAST FS as planned in July 2020 (Month 9).
The FS aims to identify candidate digital parameters of fatigue and sleep disturbances to be further tested in the subsequent, larger clinical validation study (CVS). Four European centres (Universitätsklinikum Schleswig-Holstein, Campus Kiel (UKSH), Newcastle upon Tyne Hospitals NHS Foundation Trust/Newcastle University (UNEW), Erasmus University Medical Centre (EMC), and George-Huntington-Institut GmbH (GHI)) will investigate this research question in four parallel studies in different disease populations which include Parkinson’s disease (PD), Huntington’s Disease (HD) inflammatory bowel disease (IBD), primary Sjögren’s syndrome (PSS), rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) as well as healthy volunteers (HV). Participants will be asked to report sleep disturbances and fatigue by means of questionnaires and a digital diary during a study period of 28-36 days. During the study period, they will also use various digital devices/technologies for four periods of five days each (devices worn consecutively, maximum of three devices simultaneously in addition to a smartphone). Measures collected through novel digital tools will be compared with traditional measures: i) clinical outcomes (e.g., surveys) and ii) patient-reported outcomes (questionnaires and diaries). Digital measures which best correlate with the patient-reported measures of sleep disturbances and fatigue as well as the clinical outcome measures will be considered for further investigations in the CVS. The FS will also assess usability, acceptability, tolerability and compliance aspects concerning the different digital technologies as well as social functioning measures.
