An interventional study of iPROLEPSIS Digital Health Ecossystem in Psoriatic Arthritis (PsA), sponsored by Sociedade Portuguesa de Reumatologia. Not yet recruiting at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Sociedade Portuguesa de Reumatologia · Not applicable, Interventional, and Other
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.
600 studies on the registry are indexed under Arthritis, Psoriatic; 129 are open to participants now.
This study's planned enrollment of 72 is below the median of 145 across 336 interventional studies indexed under Arthritis, Psoriatic.
Browse Arthritis, Psoriatic studies →This is the only study on the registry with Sociedade Portuguesa de Reumatologia as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria (Patients):
Inclusion Criteria (Healthcare Professionals):
Exclusion Criteria (Patients):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with psoriatic arthritis will undergo a 12-month study period consisting of a 1-month baseline monitoring phase followed by an 11-month intervention phase. During the intervention period, participants will receive the iPROLEPSIS digital health programme , integrated with a wearable smartwatch and wireless earbuds. Healthcare professionals involved in participant follow up will use a dedicated clinical dashboard.
Behavioral: iPROLEPSIS 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.
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.
Time frame: T0 (Month 1), T3 (Month 4), and T11 (Month 12); Healthcare professionals: T11 (Month 12)
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).
Time frame: T0 (Month 1), T3 (Month 4), and T11 (Month 12); Healthcare professionals: T11 (Month 12)
Acceptability
Number of eligible participants who agree to participate in the study.
Time frame: Baseline
Perceptions of acceptability, barriers, facilitators, and experiences (patients)
Semi-structured focus group interviews
Time frame: T11 (Month 12)
Step counts
Count of steps collected unobtrusively from the smartwatch of patient to measure physical activity. Patients will wear the smartwatch daily
Time frame: Continuous, throughout 12 months
Accelerometer data
Accelerometer data collected unobtrusively from smartphone of patient and smartwatch to measure physical activity. Patients will wear the smartwatch daily
Time frame: Continuous, throughout 12 months
Number of Flares Reported via the miPROLEPSIS Application
Number of disease flares self-reported by patients directly through the miPROLEPSIS application.
Time frame: Continuous throughout 12 months
Number of Flares Reported via Patient and Rheumatologist
Count of disease flares reported using the structured Patient and Rheumatologist flare questionnaires developed in the iPROLEPSIS-PDPID study, completed during clinical visits.
Time frame: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12);
Body Mass Index (BMI)
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).
Time frame: Baseline
Minimal Disease Activity (MDA) status
Minimal Disease Activity status based on predefined criteria, determined from joint counts, pain, global activity, and function.
Time frame: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Psoriatic Arthritis Disease Activity Score (PASDAS)
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.
Time frame: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Disease Activity in Psoriatic Arthritis (DAPSA) Score
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.
Time frame: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Psoriatic Arthritis Impact of Disease (PsAID)
Validated patient-reported measure assessing disease impact across domains such as pain, fatigue, work, and emotional well-being
Time frame: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Arthritis Self-Efficacy Scale (ASES)
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.
Time frame: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Patient Health Questionnaire-9 (PHQ-9)
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
Time frame: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Perceived Stress Scale (PSS)
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.
Time frame: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Short Form-36 Health Survey (SF-36)
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.
Time frame: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
International Physical Activity Questionnaire - Short Form (IPAQ-SF)
Self-reported physical activity levels across intensity domains (walking, moderate, vigorous), duration, and frequency over the past 7 days
Time frame: T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Health Assessment Questionnaire Disability Index (HAQ-DI)
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.
Time frame: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
14-item Mediterranean Diet Adherence Screener (14-MEDAS)
Questionnaire assessing adherence to Mediterranean dietary pattern. Score ranges from 0 to 14; higher scores reflect greater adherence.
Time frame: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
EuroQoL 5-Dimensions 5-Levels (EQ-5D-5L)
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).
Time frame: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Work Productivity and Activity Impairment (WPAI)
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.
Time frame: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12);
Healthcare utilisation
Self-reported use of healthcare services, including visits to GPs and specialists.
Time frame: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Safety assessment
Number of adverse events (AEs) and serious adverse events (SAEs).
Time frame: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Heart rate
Heart rate collected unobtrusively from smartwatch of patient. Patients will wear the smartwatch daily
Time frame: Continuous throughout 12 months
Heart rate variability
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.
Time frame: Continuous throughout 12 months
Stress (digital)
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
Time frame: Continuous throughout 12 months
Sleeping time
Sleeping time (hours) collected unobtrusively from smartwatch of patient
Time frame: Continuous throughout 12 months
Sleeping type
Sleeping type (%) collected unobtrusively from smartwatch of patient
Time frame: Continuous throughout 12 months
Hand and feet photos
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
Time frame: 12 months (follow-up every 6 weeks and in case of flare)
Hand and body movements videos
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
Time frame: 12 months (follow-up every 6 weeks and in case of flare)
Physical activity intensity and categories
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
Time frame: Continuous throughout 12 months
Gyroscope sensor data
Gyroscope sensor data for orientation collected unobtrusively from smartphone of patient
Time frame: Continuous throughout 12 months
Keystroke Dynamics
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.
Time frame: Continuous throughout 12 months
Session Frequency (iPROLEPSIS apps)
Number of discrete user sessions or app log-ins over the study period, indicating engagement consistency and sustained participation.
Time frame: Continuous, through 12 months of follow-up
Session Duration (iPROLEPSIS apps)
Dwell time within each application, i.e., duration of each user session, in minutes.
Time frame: Continuous, throughout 11 months
Feature Access Rate (iPROLEPSIS Apps)
Number of times users access specific app features or modules, reflecting breadth and depth of feature engagement.
Time frame: Continuous throughout 12 months
Task Completion Rate (iPROLEPSIS Apps)
Ratio of the number of completed tasks to the number of abandoned or incomplete tasks
Time frame: Continuous throughout 12 months
Notification Action Rate (iPROLEPSIS Apps)
Ratio of the number of opened notifications to the number of resulting task completions
Time frame: Continuous throughout 12 months
Time on Task (iPROLEPSIS Apps)
Time taken by users to complete a defined in-app task, in minutes.
Time frame: Continuous throughout 12 months
Error Rate (iPROLEPSIS Apps)
Application) Ratio of the number of successful task attempts to the number of failed attempts (e.g., failed photo submissions or failed video tests).
Time frame: Continuous throughout 12 months
User-Generated Data Entries (iPROLEPSIS Apps)
Frequency and quantity of user-initiated data input, indicating active engagement and perceived app utility
Time frame: Continuous throughout 12 months
Number of Dashboard Sessions Logged (HCP Dashboard)
Number of times healthcare professionals log into the iPROLEPSIS clinical dashboard
Time frame: Continuous throughout 12 months
Incremental Cost of Implementing the iPROLEPSIS Digital Health Programme Compared with Standard Care
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.
Time frame: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Genetic variants
Salivary DNA analysis
Time frame: T0 (1-Month)
Gut microbiome
Stool analysis to extract bacterial DNA using 16S sequencing
Time frame: T0 (1-Month) and T3 (4-Month)
Inflammatory blood marker
Blood C-reactive protein levels (ml/L)
Time frame: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Waist Circumference
Waist circumference, measured in centimeters.
Time frame: Baseline
Clinical and Disease History Characteristics
Descriptive clinical history collected at enrolment, including fulfilment of CASPAR classification criteria for psoriatic arthritis, psoriatic arthritis subtype, symptom onset date, diagnosis date, and comorbidities.
Time frame: Baseline
Demographics
Descriptive characteristics collected at enrolment, including age, sex, nationality, ethnicity/race, marital status, household composition, education level, digital literacy, professional occupation/shift work, handedness and typing fingers used, birth history (mode of delivery: caesarean vs. vaginal), presence of family care/dependent responsibilities, dietary habits, alcohol consumption, and smoking status.
Time frame: Baseline
Global Rating of Change (GRoC) Scale
GRoC scale to evaluate change in disease activity.
Time frame: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Life events questionnaire
Life events questionnaire for life events
Time frame: Baseline, and T11 (Month 12)
Digital literacy questionnaire
Digital literacy questionnaire for technology readiness
Time frame: Baseline
Morning stiffness
Morning stiffness on a 10-point Likert scale. Higher scores indicate higher morning stiffness.
Time frame: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Air travel events
Air travel during the study period, including the occurrence, number, dates and purpose (vacation or work), as reported by participants.
Time frame: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Supplement use
Use of dietary supplements, including supplement type, dose, frequency, and duration of use, as reported by participants.
Time frame: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Joint count
66/68 joint count for swelling and tenderness. Higher count indicates higher swollen/tender joints.
Time frame: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Enthesitis
6 tendon count for enthesitis using Leeds Enthesitis Index
Time frame: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Psoriasis Area and Severity Index (PASI)
Physician-assessed measure of psoriasis severity and extent across four body regions (head, trunk, upper limbs, lower limbs), combining erythema, induration, and desquamation with area affected. Score ranges from 0-72; higher scores indicate more severe/extensive disease.
Time frame: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Dactylitis Severity Score (DSS)
Physician-assessed measure of dactylitis severity, scored per digit (fingers and toes) on a scale from 0 (no dactylitis) to 3 (most severe). The total score is the sum across all assessed digits, yielding a possible total range of 0 to 60; higher scores indicate more severe dactylitis.
Time frame: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Life Satisfaction
Self-reported life satisfaction (0-10).
Time frame: Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Dec 2027, 15 months later.
Of 67 non-industry interventional studies with no phase under Arthritis, Psoriatic, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 43. This study's planned 15 months is below that.
Counting every sponsor, half of 72 studies reached it within 31 months; a quarter within 13 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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