For the past eighteen months, the WP4 team has been extremely busy with several processes running in parallel.
The feasibility study, which tested the intervention arm of the main trial, was completed in June 2022 at the Göttingen site. The feasibility study included 10 patients who received the blended-collaborative care (BCC) intervention for three months. The feasibility study provided the team with invaluable lessons on the screening and consenting process for patients, the assessment of the patient data from questionnaires and phone conversations, and the use of the patient registry. These learnings were then applied to the main clinical study to optimise the imergo® e-health platform and develop standard operation procedures (SOPs) and care managers guidelines.
Alongside the feasibility study, was the preparation of the main clinical trial. This involved the creation and translation of all study documents, that were then submitted to eleven different ethical committees for approval. This laborious evaluation process took several months with back-and-forth communication to ensure compliance with all relevant authorities.
In additional to receiving ethical approval, there were several conditions that each site had to comply with to get the “green light” and begin recruitment. Notably, each site had to recruit and train a quality-control monitor, carry out a thorough training for the local staff and undergo a pre-study assessment. When all conditions were met, the sites received the “green light” and could finally begin screening patients.
The official start of the clinical trial on April 1st was a big milestone and we were glad to achieve it on time. Recruitment first began at Göttingen followed by eight additional sites, Cologne, Hamburg, Leipzig, Roskilde, Slagelse, Kaunas, Bologna and Odense. As of September 29th, Göttingen has included 13 patients in the RCT and began the intervention. The other “green light” sites are currently screening patients for the RCT and will conduct their first baseline visits and randomisations in Fall 2022.
ESCAPE utilises the online EDC system secuTrial® and SOPs to ensure trial implementation is standardised across the different countries while maintaining patient safety and data integrity. UMG, in collaboration with ESCAPE partners, drafted the clinical trial protocol, which will be submitted for publication in Fall 2022.