iPROLEPSIS-PPIDC: Prevention of Psoriatic Arthritis Inflammation Through Digital Care: A Feasibility Mixed-Methods Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 4
- 主要终点
- System Usability Scale (SUS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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
排除标准
- •(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)
研究组 & 干预措施
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.
干预措施: iPROLEPSIS Digital Health Ecossystem (Behavioral)
结局指标
主要结局
System Usability Scale (SUS)
时间窗: 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)
时间窗: 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).
次要结局
- Accelerometer data(Continuous, throughout 12 months)
- Acceptability(Baseline)
- Perceptions of acceptability, barriers, facilitators, and experiences (patients)(T11 (Month 12))
- Step counts(Continuous, throughout 12 months)
- Number of Flares Reported via the miPROLEPSIS Application(Continuous throughout 12 months)
- Number of Flares Reported via Patient and Rheumatologist(Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12);)
- Body Mass Index (BMI)(Baseline)
- Minimal Disease Activity (MDA) status(Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12))
- Psoriatic Arthritis Disease Activity Score (PASDAS)(Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12))
- Disease Activity in Psoriatic Arthritis (DAPSA) Score(Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12))
- Psoriatic Arthritis Impact of Disease (PsAID)(Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12))
- Arthritis Self-Efficacy Scale (ASES)(Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12))
- Patient Health Questionnaire-9 (PHQ-9)(Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12))
- Perceived Stress Scale (PSS)(Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12))
- Short Form-36 Health Survey (SF-36)(Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12))
- International Physical Activity Questionnaire - Short Form (IPAQ-SF)(T0 (Month 1), T3 (Month 4), and T11 (Month 12))
- Health Assessment Questionnaire Disability Index (HAQ-DI)(Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12))
- 14-item Mediterranean Diet Adherence Screener (14-MEDAS)(Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12))
- EuroQoL 5-Dimensions 5-Levels (EQ-5D-5L)(Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12))
- Work Productivity and Activity Impairment (WPAI)(Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12);)
- Healthcare utilisation(Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12))
- Safety assessment(Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12))
- Heart rate(Continuous throughout 12 months)
- Heart rate variability(Continuous throughout 12 months)
- Stress (digital)(Continuous throughout 12 months)
- Sleeping time(Continuous throughout 12 months)
- Sleeping type(Continuous throughout 12 months)
- Hand and feet photos(12 months (follow-up every 6 weeks and in case of flare))
- Hand and body movements videos(12 months (follow-up every 6 weeks and in case of flare))
- Physical activity intensity and categories(Continuous throughout 12 months)
- Gyroscope sensor data(Continuous throughout 12 months)
- Keystroke Dynamics(Continuous throughout 12 months)
- Session Frequency (iPROLEPSIS apps)(Continuous, through 12 months of follow-up)
- Session Duration (iPROLEPSIS apps)(Continuous, throughout 11 months)
- Feature Access Rate (iPROLEPSIS Apps)(Continuous throughout 12 months)
- Task Completion Rate (iPROLEPSIS Apps)(Continuous throughout 12 months)
- Notification Action Rate (iPROLEPSIS Apps)(Continuous throughout 12 months)
- Time on Task (iPROLEPSIS Apps)(Continuous throughout 12 months)
- Error Rate (iPROLEPSIS Apps)(Continuous throughout 12 months)
- User-Generated Data Entries (iPROLEPSIS Apps)(Continuous throughout 12 months)
- Number of Dashboard Sessions Logged (HCP Dashboard)(Continuous throughout 12 months)
- Incremental Cost of Implementing the iPROLEPSIS Digital Health Programme Compared with Standard Care(Baseline, T0 (Month 1), T3 (Month 4), and T11 (Month 12))