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

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)