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

NCT07772544 | Not Yet Recruiting

• 2 other identifiers: 014/2026/CENMS101095697
• Study Type: interventional
• Target: 72
• Locations: 2 countries
• Sites: 4

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.

Conditions

Psoriatic Arthritis (PsA)

Keywords

Psoriatic Arthritis; Digital Health; Feasibility Study; Usability; Disease Self-Management; Digital Biomarkers; Remote Monitoring; eHealth

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (42)

• Acceptability

  Baseline

• Perceptions of acceptability, barriers, facilitators, and experiences (patients)

  T11 (Month 12)

• Step counts

  Continuous, throughout 12 months

• Accelerometer data

  Continuous, throughout 12 months

• Number of Flares Reported via the miPROLEPSIS Application

  Continuous throughout 12 months

Other Outcomes (17)

• Genetic variants

  T0 (1-Month)

• Gut microbiome

  T0 (1-Month) and T3 (4-Month)

• Inflammatory blood marker

  Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12)

Study Arms (1)

iPROLEPSIS Digital Health Ecossystem

EXPERIMENTAL

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

Interventions

iPROLEPSIS Digital Health Ecossystem BEHAVIORAL

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.

iPROLEPSIS Digital Health Ecossystem

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Willing and able to provide informed consent
• Involved in the clinical follow-up of PsA patients enrolled in the study

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sociedade Portuguesa de Reumatologia: lead
• Erasmus Medical Center: collaborator
• University of Oxford: collaborator
• NOVA Medical School: collaborator
• Aristotle University Of Thessaloniki: collaborator

Study Sites (4)

Hipokrateion Hospital Thessaloniki

Thessaloniki, Greece

Location

Unidade Local de Saúde de Aveiro, Serviço de Reumatologia, Hospital Infante Dom Pedro

Aveiro, Portugal

Location

Unidade Local de Saúde de São José, Serviço de Reumatologia, Hospital Santo António dos Capuchos

Lisbon, Portugal

Location

Unidade Local de Saúde de São João, Serviço de Reumatologia, Hospital São João

Porto, Portugal

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ana Maria Rodrigues, MD, PhD

  NOVA Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Maria Rodrigues, MD, PhD

CONTACT

+351 965555061; ana.m.rodrigues@nms.ul.pt

Cátia Gonçalves, PhD

CONTACT

catia.goncalves@nms.unl.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2026
• First Posted: August 19, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-09

Locations

PT (3); GR (1)