The Clinical Observation Study (COS) is on a roll, and we are proud to present the first Newsletter of the IDEA-FAST COS, with the latest recruitment status.
The COS is an ambitious study with the aim to identify digital endpoints to better assess fatigue and sleep disturbances. To gather a significant sample size for data analysis, we aim to recruit approximately 2000 participants from 6 different cohort diseases, representing both Immune-Mediated Inflammatory Diseases and Neurodegenerative Diseases. The participants will wear a combination of 3-4 digital devices and will be asked to report on their experience over a course of a year. The study is set to take place in 9 European countries, with 20 recruiting sites and the recruitment taking place in 3 batches as follows:
- 1st batch: 1st June 2022-31st December 2022
- 2nd batch: 1st July 2023-31st October 2023
- 3rd batch: 1st May 2024-31st July 2024
In line with ethical requirements, all recruitment sites have applied for ethical approval at the local committees. We are proud to announce that 13 sites have opened and are successfully recruiting patients, with 7 additional sites to be included soon. A total of 132 participants have been recruited so far. The sites in Kiel, Brescia, Stavanger, Newcastle, Lisbon, Münster, Madrid, Roxal Devon, Innsbruck, and University of Glasgow have already started recruiting patients, and Leeds, Warshaw and London Barts will soon follow.
We are grateful for all the efforts of investigators, cohort leads, and recruiting staff in helping this study to be a success. Together, data from all study sites will be used to take a step towards the continued development of digital endpoints for sleep and fatigue disturbances.