ESCAPE’s Cohort Study & Randomised Controlled Trial (Work Package 4) is led by University Medical Center Göttingen (UMG). In collaboration with the WP4 team, UMG has been engaged with the preparation of the feasibility trial, which has been ongoing from October 2021 and will wrap up in March 2022. The main clinical trial is then set to start in Spring 2022.
When running a feasibility and clinical trial, projects must secure ethical approval to ensure the protection of the participants and their data. As such, the clinical trial protocol, the patient information and consent forms, and other trial documents have been submitted and approved by the UMG ethics committee for both the feasibility and main trials.
With this first milestone completed, WP4 is now focused on the following three related tasks to ensure a smooth start to the main clinical trial:
- Translating all materials needed for the international partner sites. The clinical trials will take place in Germany, Denmark, Ireland, Lithuania, Italy and Hungary. WP4 is making good progress due to the close cooperation between partners!
- Preparation of a database that will be used to enter and store all data from the clinical trial sites. With the German test version already launched, The next step will be to implement analogous versions in Danish, English, Italian, Lithuanian, and Hungarian.
- The feasibility trial to simulate the intervention arm of the main clinical trial. The goal is to gather experience with the processes involved, for example screening potential participants, obtaining informed consent, assessing and storing medical history, and performing a short version of ESCAPE’s blended-collaborative care (BCC) intervention. The imergo® e-health platform will also be tested in the upcoming weeks. WP4 will work in close cooperation with WP2 (Development of the Blended-Collaborative Care Intervention) to ensure potential problems are cleared before the main trial starts.
WP4 has recruited six participants so far, who are now receiving support from the designated care managers and being supervised by a team of renowned experts from different medical fields. The feasibility trial has already given ESCAPE invaluable opportunities for troubleshooting and optimisation of the complex processes involved in the coordination of BCC intervention.
Pictured in the top right is Care Manager, Conni Regner, supporting one of the participants in the feasibility trial.
Pictured below is clinical co-coordinators Jonas Nagel and Christine Zelenak discussing study procedures.
Follow ESCAPE for updates on the clinical trial as it begins in Spring 2022!