This is an international, multicentre, feasibility mixed-methods, single-arm study evaluating the implementation of the iPROLEPSIS digital health promotion programme for adults with psoriatic arthritis (PsA) in real-world clinical practice.
The study will enrol 72 adults with PsA (18 participants per country) across Portugal, the Netherlands, Greece, and the United Kingdom. Participants will be followed for 12 months, including a 1-month baseline monitoring period without intervention, followed by an 11-month intervention period during which participants will use the iPROLEPSIS digital health ecosystem. The iPROLEPSIS ecosystem integrates multiple digital health tools designed to support lifestyle management, self-monitoring, and patient engagement in PsA care. Participants will use the miPROLEPSIS app for active and passive data collection and personalised lifestyle recommendations related to diet and physical activity; biAURA for sleep and stress management using binaural beats; iPROLEPSIS Games to promote physical and emotional well-beingthrough serious games; and the miPROLEPSIS Joint Landmarker app for video-based functional assessments. The ecosystem will also integrate data from a Garmin vívoactive 5 smartwatch and wireless earbuds. Healthcare professionals involved in participant follow-up will access a dedicated clinical dashboard to support monitoring and clinical management. The primary objective of this feasibility study is to evaluate the usability of the iPROLEPSIS digital health ecosystem among patients with PsA and healthcare professionals using the System Usability Scale (SUS) and the eHealth UsaBility Benchmarking Instrument (HUBBI). Secondary objectives include assessing participant retention, acceptability of study participation, engagement with the digital health tools, adherence to study procedures, and identifying barriers and facilitators influencing the implementation of the digital health programme in routine clinical practice.The study will also generate preliminary evidence regarding potential changes in clinical and patient-reported outcomes associated with the use of the iPROLEPSIS ecosystem and include a preliminary budget impact analysis to inform the design of a future larger-scale clinical trial.
Willing and able to provide informed consent
Female or male, aged 18 years or older at the time of enrolment
Diagnosed with psoriatic arthritis
Had a rheumatology appointment in the past 12 months
Illiteracy or inability to comply with the study protocol (e.g., due to hearing or visual impairments or significant cognitive impairment)
Lack of access to the necessary technology to participate in the study (e.g., smartphone or stable internet connection)
Single group
iPROLEPSIS Digital Health Ecossystem
BehavioralThe iPROLEPSIS Digital Health Programme is a multimodal digital health intervention designed to support self-management, healthy lifestyle behaviours, and remote clinical follow-up in adults with psoriatic arthritis. Participants will use the miPROLEPSIS mobile application for symptom monitoring, passive and active data collection, and personalised lifestyle recommendations; biAURA for sleep and stress management; iPROLEPSIS Games to promote physical and emotional well-being; and the miPROLEPSIS Joint Landmarker application for video-based functional assessment. The ecossystem also integrates a smartwatch and wireless earbuds. Healthcare professionals will use a dedicated clinical dashboard to monitor participant data and support clinical management throughout the intervention period.
System Usability Scale (SUS)
A validated 10-item questionnaire assessing ease of system use, scored on a 5-point Likert scale and converted to a 0-100 scale. A score ≥68 indicates above-average usability.
eHealth UsaBility Benchmarking instrument (HUBBI)
A structured heuristic tool assessing usability across seven domains (Basic System Performance, Task-Technology Fit, Interface Design, Navigation \& Structure, Information \& Terminology, Guidance \& Support, Satisfaction). Results are presented as categorical ratings (Good, Moderate, Insufficient, Poor).
Acceptability
Number of eligible participants who agree to participate in the study.
Perceptions of acceptability, barriers, facilitators, and experiences (patients)
Semi-structured focus group interviews
Step counts
Count of steps collected unobtrusively from the smartwatch of patient to measure physical activity. Patients will wear the smartwatch daily
Accelerometer data
Accelerometer data collected unobtrusively from smartphone of patient and smartwatch to measure physical activity. Patients will wear the smartwatch daily
Genetic variants
Salivary DNA analysis
Gut microbiome
Stool analysis to extract bacterial DNA using 16S sequencing
Inflammatory blood marker
Blood C-reactive protein levels (ml/L)
Waist Circumference
Waist circumference, measured in centimeters.
Click on the lead sponsor to view all of their trials.
Sociedade Portuguesa de Reumatologia
Lead sponsor
Erasmus Medical Center
Collaborator
University of Oxford
Collaborator
Aristotle University Of Thessaloniki
Collaborator
NOVA Medical School
Collaborator
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