Ongoing preparation for the iPROLEPSIS-PDPID study

Patients with Psoriatic arthritis (PsA) experience difficulties in dealing with unpredictable disease activity, which can affect their quality of life. Developing a digital biomarker using a smartphone and smartwatch would allow for unobtrusive monitoring of the disease activity in these patients. Besides, understanding what factors trigger flare would allow for better disease control. 

The iPROLEPSIS-PDPID study is a multicentre observational cohort study that aims to develop an unobtrusive and affordable digital biomarker capable of detecting changes in disease activity, including flare, and to identify triggers of flare in patients with PsA.  

• The study will be conducted in four countries: the Netherlands, the UK, Portugal and Greece.  

• Ethical approval for initiating the iPROLEPSIS-PDPID study in the Netherlands and the UK has been granted.  

• The OpenClinica platform will be used in the collection and storage of data for the iPROLEPSIS-PDPID study. 

Future steps include obtaining ethical approvals for Portugal and Greece as well as local approvals from centres participating in each country, and inclusion of patients from each participating country.  

The miPROLEPSIS phone app, currently under development, will be used in this study. The app will be installed on the patient smartphone and utilised as a data collector, which will be then used for algorithms development and training. The app will measure physical activity, the length of sleep, self-registered flare, and register daily pain, fatigue, sleep and morning stiffness. 

The Garmin smartwatch Vivoactive 5 device will be used to collect data on physical activity, heart rate, heart rate variability and sleep quality.

The collected data from Garmin will be downloaded from the miPROLEPSIS app by Wellics software (developer in the project), which allows extracting, visualising and exporting collected both company-processed data, as well as raw data.