Psoriatic Arthritis (PsA)
Conditions
Keywords
Psoriatic Arthritis, Digital Health, Feasibility Study, Usability, Disease Self-Management, Digital Biomarkers, Remote Monitoring, eHealth
Brief summary
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.
Interventions
BEHAVIORALiPROLEPSIS Digital Health Ecossystem
The 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.
Sponsors
Sociedade Portuguesa de Reumatologia
Erasmus Medical Center
University of Oxford
Aristotle University Of Thessaloniki
NOVA Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(Patients): * 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 * Owns a smartphone (Android) compatible with the study apps * Willing to use the study smartwatch (Garmin Vivoactive 5) for the 12-month follow-up period * Proficient in the local language Inclusion Criteria (Healthcare Professionals): * Willing and able to provide informed consent * Involved in the clinical follow-up of PsA patients enrolled in the study
Exclusion criteria
(Patients): * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| System Usability Scale (SUS) | T0 (Month 1), T3 (Month 4), and T11 (Month 12); Healthcare professionals: T11 (Month 12) | 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) | T0 (Month 1), T3 (Month 4), and T11 (Month 12); Healthcare professionals: T11 (Month 12) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | Baseline | Number of eligible participants who agree to participate in the study. |
| Perceptions of acceptability, barriers, facilitators, and experiences (patients) | T11 (Month 12) | Semi-structured focus group interviews |
| Step counts | Continuous, throughout 12 months | Count of steps collected unobtrusively from the smartwatch of patient to measure physical activity. Patients will wear the smartwatch daily |
| Accelerometer data | Continuous, throughout 12 months | Accelerometer data collected unobtrusively from smartphone of patient and smartwatch to measure physical activity. Patients will wear the smartwatch daily |
| Number of Flares Reported via the miPROLEPSIS Application | Continuous throughout 12 months | Number of disease flares self-reported by patients directly through the miPROLEPSIS application. |
| Number of Flares Reported via Patient and Rheumatologist | Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12); | Count of disease flares reported using the structured Patient and Rheumatologist flare questionnaires developed in the iPROLEPSIS-PDPID study, completed during clinical visits. |
| Body Mass Index (BMI) | Baseline | Calculated as weight in kilograms divided by the square of height in meters (kg/m²). Used to classify nutritional status (underweight, normal weight, overweight, obesity). |
| Minimal Disease Activity (MDA) status | Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12) | Minimal Disease Activity status based on predefined criteria, determined from joint counts, pain, global activity, and function. |
| Psoriatic Arthritis Disease Activity Score (PASDAS) | Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12) | Composite disease activity score combining clinical and patient-reported variables. Total score ranges from 0 to 10; higher scores indicate more active disease. Low disease activity is defined as a score \<3.2. |
| Disease Activity in Psoriatic Arthritis (DAPSA) Score | Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12) | Composite score derived from tender joint count (0-68), swollen joint count (0-66), C-reactive protein level (mg/dL), patient pain (0-10 cm VAS), and patient global assessment (0-10). Higher scores indicate more active disease. |
| Psoriatic Arthritis Impact of Disease (PsAID) | Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12) | Validated patient-reported measure assessing disease impact across domains such as pain, fatigue, work, and emotional well-being |
| Arthritis Self-Efficacy Scale (ASES) | Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12) | 8-item scale measuring perceived self-efficacy in managing pain and other arthritis-related symptoms. Scores range from 10 to 100, with higher scores indicating greater self-efficacy. |
| Patient Health Questionnaire-9 (PHQ-9) | Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12) | 9-item instrument for screening and measuring the severity of depressive symptoms in the previous two weeks. Score ranges from 0 to 27. Higher scores indicate more severe depressive symptoms |
| Perceived Stress Scale (PSS) | Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12) | Self-reported questionnaire measuring the degree to which individuals perceive their life situations as stressful, over the past month. Scores are calculated by summing item responses, with higher scores indicating greater perceived stress. |
| Short Form-36 Health Survey (SF-36) | Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12) | Standardised questionnaire assessing assessing health-related quality of live across eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores are transformed to a 0-100 scale. Higher scores indicate better health status. |
| International Physical Activity Questionnaire - Short Form (IPAQ-SF) | T0 (Month 1), T3 (Month 4), and T11 (Month 12) | Self-reported physical activity levels across intensity domains (walking, moderate, vigorous), duration, and frequency over the past 7 days |
| Health Assessment Questionnaire Disability Index (HAQ-DI) | Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12) | 20-item scale assessing difficulties in performing daily activities. Responses range from 0 (no difficulty) to 3 (unable to do). Higher scores indicate worse functional disability. |
| 14-item Mediterranean Diet Adherence Screener (14-MEDAS) | Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12) | Questionnaire assessing adherence to Mediterranean dietary pattern. Score ranges from 0 to 14; higher scores reflect greater adherence. |
| EuroQoL 5-Dimensions 5-Levels (EQ-5D-5L) | Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12) | Standardised instrument measuring quality of life across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Includes an index score and visual analogue scale (VAS). |
| Work Productivity and Activity Impairment (WPAI) | Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12); | Self-reported questionnaire measuring the degree to which health problems affect work productivity and regular activities. Includes absenteeism, presenteeism, and overall work and activity impairment. |
| Healthcare utilisation | Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12) | Self-reported use of healthcare services, including visits to GPs and specialists. |
| Safety assessment | Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12) | Number of adverse events (AEs) and serious adverse events (SAEs). |
| Heart rate | Continuous throughout 12 months | Heart rate collected unobtrusively from smartwatch of patient. Patients will wear the smartwatch daily |
| Heart rate variability | Continuous throughout 12 months | Heart rate variability (HRV) collected unobtrusively from the patient's smartwatch to assess variations in heart rate. This is a feature provided by the smartwatch. Patients will wear the smartwatch daily. |
| Stress (digital) | Continuous throughout 12 months | Stress levels collected unobtrusively from smartwatch of patient to measure stress on a scale. This is a feature provided by the smartwatch. Patients will wear the smartwatch daily |
| Sleeping time | Continuous throughout 12 months | Sleeping time (hours) collected unobtrusively from smartwatch of patient |
| Sleeping type | Continuous throughout 12 months | Sleeping type (%) collected unobtrusively from smartwatch of patient |
| Hand and feet photos | 12 months (follow-up every 6 weeks and in case of flare) | Images of hands and feet of the patient captured by the smartphone camera of the patient, to produce a feature vector relative to the condition of nails and joints of hands and toes resulting in an imaging digital biomarker |
| Hand and body movements videos | 12 months (follow-up every 6 weeks and in case of flare) | Videos of pre-specified movements of hand and body recorded by the smartphone camera of the patient, to produce a set of time series with landmark coordinates (obtained from the videos) resulting in an imaging digital biomarker |
| Physical activity intensity and categories | Continuous throughout 12 months | Physical activity intensity and physical activity categories collected unobtrusively from the smartwatch of patient to measure physical activity. Intensity and categories are features provided by the smartwatch. Patients will wear the smartwatch daily |
| Gyroscope sensor data | Continuous throughout 12 months | Gyroscope sensor data for orientation collected unobtrusively from smartphone of patient |
| Keystroke Dynamics | Continuous throughout 12 months | Keypad time-related data (e.g., inter-key press intervals) and associated metadata, collected unobtrusively from the patient's smartphone during app use, for fine motor function. |
| Session Frequency (iPROLEPSIS apps) | Continuous, through 12 months of follow-up | Number of discrete user sessions or app log-ins over the study period, indicating engagement consistency and sustained participation. |
| Session Duration (iPROLEPSIS apps) | Continuous, throughout 11 months | Dwell time within each application, i.e., duration of each user session, in minutes. |
| Feature Access Rate (iPROLEPSIS Apps) | Continuous throughout 12 months | Number of times users access specific app features or modules, reflecting breadth and depth of feature engagement. |
| Task Completion Rate (iPROLEPSIS Apps) | Continuous throughout 12 months | Ratio of the number of completed tasks to the number of abandoned or incomplete tasks |
| Notification Action Rate (iPROLEPSIS Apps) | Continuous throughout 12 months | Ratio of the number of opened notifications to the number of resulting task completions |
| Time on Task (iPROLEPSIS Apps) | Continuous throughout 12 months | Time taken by users to complete a defined in-app task, in minutes. |
| Error Rate (iPROLEPSIS Apps) | Continuous throughout 12 months | Application) Ratio of the number of successful task attempts to the number of failed attempts (e.g., failed photo submissions or failed video tests). |
| User-Generated Data Entries (iPROLEPSIS Apps) | Continuous throughout 12 months | Frequency and quantity of user-initiated data input, indicating active engagement and perceived app utility |
| Number of Dashboard Sessions Logged (HCP Dashboard) | Continuous throughout 12 months | Number of times healthcare professionals log into the iPROLEPSIS clinical dashboard |
| Incremental Cost of Implementing the iPROLEPSIS Digital Health Programme Compared with Standard Care | Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12) | Estimated incremental cost (local currency) of implementing the iPROLEPSIS digital health tools vs. standard care, from a healthcare system perspective, including key cost drivers and sensitivity analyses. |
Countries
Greece, Portugal
Contacts
CONTACTAna Maria Rodrigues, MD, PhD
CONTACTCátia Gonçalves, PhD
PRINCIPAL_INVESTIGATORAna Maria Rodrigues, MD, PhD
NOVA Medical School
Outcome results
None listed