ReMonit Gout feasibility study
Innovation in patient care is at the heart of the feasibility study in the ReMonit Gout project. The study will test the usability of the patient app, Urika, designed to support people starting uric acid-lowering treatment.
“The study has begun work on including 20–30 patients. It is part of the work to research digital health tools, as support tools,” says the study leader, Professor Nina Østerås.
The Urika app acts as a support tool for patients by providing personalized advice and information throughout their treatment journey. The approach aims to improve patient adherence to treatment regimens, a critical aspect of long-term management of chronic conditions, such as gout.
A carefully designed study
Participating patients will be closely followed over a period of three months, to collect data on the app's effectiveness and ease of use.
– This early phase of research will provide valuable insights, which will shape the further development of Urika, as well as lay the foundation for the planned main study – a randomized controlled trial (RCT) with 168 patients, explains Nina.
A milestone for research methodology
– As far as we know, this is the first study at the hospital to be conducted under the new EU regulation for medical devices, says Nina.
The regulation has required extensive efforts to meet all necessary documentation requirements and regulatory obligations. “ Despite the challenges, the initiation visit by the monitor from Research Support was successful ,” says Nina. She sees it as a promising sign that the preparations have been solid.
The way forward
The results of this feasibility study will be crucial for the future direction of the ReMonit Gout project. By demonstrating the effectiveness and ease of use of the Urika app, the project has the potential to transform the treatment landscape for gout patients and offer a new model for patient support in our digital age.
With a focus on innovation, patient engagement and an evidence-based approach, the ReMonit Gout project represents not only a step forward for gout treatment, but also a new way of thinking about the use of technology in patient care. As a pioneer project in the new EU regulation, it has contributed to valuable increased expertise, which can be useful in upcoming projects involving this type of medical device.
HSØ is funding PhD fellow Johan Stjärne, who is a study physician. The study team also consists of coordinator Silje Søhus and study nurses Heidi Lunøe and Gina Stenberg. The study has received three million from DAM for the further course.
