Prevention of Psoriatic Arthritis Inflammation Through Digital Care: A Feasibility Mixed-Methods Study (PPIDC)

iPROLEPSIS-PPIDC: Prevention of Psoriatic Arthritis Inflammation Through Digital Care: A Feasibility Mixed-Methods Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Psoriatic Arthritis (PsA)
• Intervention / Treatment: Behavioral: iPROLEPSIS Digital Health Ecossystem

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ana Maria Rodrigues, MD, PhD; Phone Number: +351 965555061; Email: ana.m.rodrigues@nms.ul.pt
• Study Contact Backup: Name: Cátia Gonçalves, PhD; Email: catia.goncalves@nms.unl.pt

Study Locations

• Greece
  • Thessaloniki, Greece
    • Hipokrateion Hospital Thessaloniki
    • Contact: Ioanna Katsigianni, MD; Phone Number: +30 231 089 2000; Email: katsigianniioan@gmail.com
• Portugal
  • Aveiro, Portugal
    • Unidade Local de Saúde de Aveiro, Serviço de Reumatologia, Hospital Infante Dom Pedro
    • Contact: Anabela Barcelos, MD, PhD; Phone Number: +351 966894176; Email: barcelos.anabela@gmail.com
  • Lisbon, Portugal
    • Unidade Local de Saúde de São José, Serviço de Reumatologia, Hospital Santo António dos Capuchos
    • Contact: Ana Teresa Melo, MD; Phone Number: +351 918613549; Email: anateresamelo1992@gmail.com
  • Porto, Portugal
    • Unidade Local de Saúde de São João, Serviço de Reumatologia, Hospital São João
    • Contact: Alexandra Bernardo, MD; Phone Number: +351 938507343; Email: alexbernardo@sapo.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: iPROLEPSIS Digital Health Ecossystem; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	T0 (Month 1), T3 (Month 4), and T11 (Month 12); Healthcare professionals: T11 (Month 12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gyroscope sensor data	Gyroscope sensor data for orientation collected unobtrusively from smartphone of patient	Continuous throughout 12 months
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	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	Continuous throughout 12 months
Sleeping time	Sleeping time (hours) collected unobtrusively from smartwatch of patient	Continuous throughout 12 months
Sleeping type	Sleeping type (%) collected unobtrusively from smartwatch of patient	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	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	12 months (follow-up every 6 weeks and in case of flare)
Acceptability	Number of eligible participants who agree to participate in the study.	Baseline
Perceptions of acceptability, barriers, facilitators, and experiences (patients)	Semi-structured focus group interviews	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	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	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.	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.	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).	Baseline
Minimal Disease Activity (MDA) status	Minimal Disease Activity status based on predefined criteria, determined from joint counts, pain, global activity, and function.	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.	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.	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	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.	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	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.	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.	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	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.	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.	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).	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.	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.	Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Safety assessment	Number of adverse events (AEs) and serious adverse events (SAEs).	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	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.	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.	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.	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.	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.	Continuous throughout 12 months
Task Completion Rate (iPROLEPSIS Apps)	Ratio of the number of completed tasks to the number of abandoned or incomplete tasks	Continuous throughout 12 months
Notification Action Rate (iPROLEPSIS Apps)	Ratio of the number of opened notifications to the number of resulting task completions	Continuous throughout 12 months
Time on Task (iPROLEPSIS Apps)	Time taken by users to complete a defined in-app task, in minutes.	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).	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	Continuous throughout 12 months
Number of Dashboard Sessions Logged (HCP Dashboard)	Number of times healthcare professionals log into the iPROLEPSIS clinical dashboard	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.	Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Digital literacy questionnaire	Digital literacy questionnaire for technology readiness	Baseline
Genetic variants	Salivary DNA analysis	T0 (1-Month)
Gut microbiome	Stool analysis to extract bacterial DNA using 16S sequencing	T0 (1-Month) and T3 (4-Month)
Inflammatory blood marker	Blood C-reactive protein levels (ml/L)	Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Waist Circumference	Waist circumference, measured in centimeters.	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.	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.	Baseline
Global Rating of Change (GRoC) Scale	GRoC scale to evaluate change in disease activity.	Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Life events questionnaire	Life events questionnaire for life events	Baseline, and T11 (Month 12)
Morning stiffness	Morning stiffness on a 10-point Likert scale. Higher scores indicate higher morning stiffness.	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.	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.	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.	Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Enthesitis	6 tendon count for enthesitis using Leeds Enthesitis Index	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.	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.	Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)
Life Satisfaction	Self-reported life satisfaction (0-10).	Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)

Collaborators and Investigators

• Sponsor: Sociedade Portuguesa de Reumatologia
• Collaborators: Erasmus Medical Center; University of Oxford; Aristotle University Of Thessaloniki; NOVA Medical School
• Investigators: Principal Investigator: Ana Maria Rodrigues, MD, PhD, NOVA Medical School

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: August 8, 2026
• First Submitted That Met QC Criteria: August 13, 2026
• First Posted (Actual): August 19, 2026

Study Record Updates

• Last Update Posted (Actual): August 19, 2026
• Last Update Submitted That Met QC Criteria: August 13, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Psoriatic Arthritis; eHealth; Digital Health; Remote Monitoring; Usability; Feasibility Study; Digital Biomarkers; Disease Self-Management
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Spinal Diseases; Spondylarthropathies; Skin Diseases, Papulosquamous; Skin Diseases; Spondylarthritis; Spondylitis; Psoriasis; Skin and Connective Tissue Diseases; Arthritis, Psoriatic
• Other Study ID Numbers: 014/2026/CENMS; 101095697 (Other Grant/Funding Number: European Union (HORIZON-HLTH-2022 STAYHLTH-02-01))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No