The IDEA-FAST project aims to identify digital endpoints for fatigue and sleep disturbances that will provide a more sensitive, reliable measure of the severity and impact of these symptoms in a real life setting.
Although COVID-19 restrictions had their implications, Consortium members have been busy adapting to the new situation and developping alternative plans. Here we provide you with a high-level overview of their recent activites and achievements.
On 10 February, the kick-off meeting was held at the Newcastle United Football Club. Fai Ng and Fred Baribaud described the concept & approach for the project and strategies for identifying digital endpoints and presented the project implementation including governance structure, Work Packages and their interaction. Colm Carroll presented the role of Innovative Medicines Initative (IMI) and he introduced several closely related IMI projects for potential collaboration and learning. Mike Jackson and Sofia Jacob introduced the project management and shared some organisational thoughts. Walter Mätzler (IDEA-FAST representative on Neuronet’s Scientific Coordination Board) and Virginia Parks shared clinical knowledge and insight and highlighted the main task for the following six months, which were the feasibility study and a secure electronic data capture system and patient-facing portal to support the study. Jan Smeddinck and Ioannis Pandis presented the digital devices and technology going to be used in the project. Mark van Gils and Andrew McCarthy described the device-specific data analysis and performance assessment. Kai Sun and Ioannis Pandis demonstrated the data management strategy for clinical data and sensor measurements. The general data analytics package distinct from the device specific work was presented by Jérôme Kalifa. Laura Vieweg presented the clinical validation study organisation and management. The objectives of data protection, ethics and legal challenges were presented by Evert-Ben van Veen, including guidance and support for patient involvement. Daniel Schmidtmann presented the dissemination channels Website, Twitter and LinkedIn and Veli Stroetmann described the planned work on sustainability and exploitation, including regulatory questions relevant to the project.
- Six wearables
- Two stationary at-home devices
- Two phone apps
This allowed them to get plenty of valuable digital measures including:
- movement data,
- digital social interaction data,
- and physiological data such as heart rate and brain waves (electroencephalogram)
In combination with fatigue and sleep disturbance reports from the participants, this study will allow the consortium to judge which of the tested digital parameters are the most reliable and relevant for their larger validation study that will start in 2022.
Kirsten from Kiel using the CANTAB test from Cambridge Cognition to ensure her cognitive function is up to speed to support the first participant during the feasibility study
Example of device combination that will be worn by the feasibility study participants
Affected by COVID-19
As all ongoing projects, also the feasibility study was and continues to be affected by the Covid-19 pandemic. Unfortunately, their device hub in Newcastle was one of the more affected sites, so the team in Newcastle had to work extra hard to make sure that, despite all the restrictions, devices and support material could be delivered in time. Due to a tremendous group effort, they managed to get the feasibility study devices shipped just in time for the study start in July. Thankfully, Kiel in Northern Germany was at that moment one of the less affected places, so they were able to start with the first participant in Kiel. Thanks to many emails and video conferences between the clinical team in Kiel and Newcastle, the device team, the device and app partners and the database team, the Kiel team was able to successfully test devices already.
On 17 August, the IDEA-FAST consortium announced that the data management platform’s first release went live. The platform has been deployed and is ready to receive data collected from the Feasibility Study. Data management is needed to help correlate statistics as well as aggregate data to check on its current status. Using software from companies such as Bamboo Solutions can help achieve this in a positive and professional way.
At the beginning of November the consortium was pleased to announce that, for the Feasibility Study, the four pilot centres – University of Newcastle upon Tyne (UK), Universitätsklinikum Schleswig-Holstein (GER), Erasmus Universitair Medisch Centrum Rotterdam (NL), and George-Huntington-Institut (GER) – have all received ethical approval for recruitment. Some of the sites have already been actively recruiting and training participants and now the remaining centres can start the process.
The IDEA-FAST Blog has published its first contribution from Kirsten Emmert on the feasibility study:
Thursday and Friday ( November 5 and 6) saw the running of the first IDEA-FAST Hackathon. It was a great success with 25+ participants from across Europe, spanning 8 partner organisations and 5 work packages. The consortium saw key advances in an App for Clinical Site Professionals, on Data Analytics from Different Types of Wearable Devices, as well as Data Flows and Integration in the larger IDEA-FAST Tech Ecosystem.
Check out the IDEA-FAST website for more information.