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| Name | Class |
|---|---|
| University of Oxford - Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences | UNKNOWN |
| Aristotle University Of Thessaloniki | OTHER |
| Portuguese Society of Rheumatology - The Rheumatic Diseases Portuguese Registry (Reuma.pt) |
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The goal of this observational study is to develop and internally validate a machine learning model for detecting flare using a digital biomarker and a machine learning model for predicting flare, in patients with psoriatic arthritis. The main questions it aims to answer are:
Participants will be requested to:
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| Measure | Description | Time Frame |
|---|---|---|
| Absence of flare in patients | Flare in psoriatic arthritis evaluated as: Patients
Patient Acceptable Symptom State - 'If you were to remain for the next few months as you were during the last 48 hours, would this be acceptable or unacceptable for you?' yes/ no Doctors
| 12 months (follow-up every 3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Minimal disease Activity (MDA) | MDA as defined by patient meeting 5 out of 7 of the following criteria: (i) tender joint count ≤1; (ii) swollen joint count ≤1; (iii) Psoriasis Area and Severity Index ≤ 1 or body surface area ≤3%; (iv) tender entheseal points ≤ 1 (v) patient pain visual analogue scale VAS ≤15; (vi) patient global activity VAS ≤20; (vii) Health Assessment Questionnaire (HAQ) ≤0.5 | 12 months (follow-up every 3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Keystroke dynamics | Keypad time-related data and metadata collected unobtrusively from smartphone of patient | Continuous throughout 12 months |
| Screen time | Screen time (hours) metrics collected unobtrusively from smartphone of patient |
Inclusion Criteria:
Exclusion Criteria:
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Patients with psoriatic arthritis
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| Label | URL |
|---|---|
| iPROLEPSIS project website | View source |
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| D000067251 | Symptom Flare Up |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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| Psoriatic Arthritis Disease Activity Score (PASDAS) | PASDAS calculated as a composite score using the following criteria: physician global VAS, patient global VAS, SF36 physical (PCS), swollen joint count, tender joint count, Leeds Enthesitis Index, tender dactylitis count, and CRP. Higher scores indicate higher disease activity. | 12 months (follow-up every 3 months) |
| Disease Activity Psoriatic Arthritis (DAPSA) | DAPSA calculated as a summation score of the following: tender and swollen joints, patient global assessment VAS, patient pain VAS and C-reactive protein. Higher scores indicate higher disease activity. | 12 months (follow-up every 3 months) |
| Psoriatic Arthritis Impact of Disease (PsAID) | PsAID:10-point Likert scale questions on 12 items (pain, fatigue, skin, work/leisure activities, functional capacity, discomfort, sleep, coping, anxiety, embarrassment, social life, depression). Higher score indicates higher impact of disease. | 12 months (follow-up every 3 months) |
| Morning stiffness | Morning stiffness on a 10-point Likert scale. Higher scores indicate higher morning stiffness. | 12 months (follow-up every 3 months) |
| 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 |
| Gyroscope sensor data | Gyroscope sensor data for orientation collected unobtrusively from smartphone of patient | Continuous throughout 12 months |
| Steps count | Count of steps collected unobtrusively from the smartwatch of patient to measure physical activity. Patients will wear the smartwatch daily | 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 |
| Motion | Motion intensity collected unobtrusively smartwatch of patient to measure physical activity. This is a feature provided by the smartwatch. Patients will wear the smartwatch daily | Continuous throughout 12 months |
| Distance | Distance (km) collected unobtrusively from smartwatch of patient to measure physical activity. Patients will wear the smartwatch daily | Continuous throughout 12 months |
| Pulse Ox | Pulse Ox collected unobtrusively from smartwatch of patient to measure physical activity. Patients will wear the smartwatch daily | Continuous throughout 12 months |
| Respiration | Respiration rate collected unobtrusively from smartwatch of patient to measure physical activity. Patients will wear the smartwatch daily | Continuous throughout 12 months |
| Body battery | Body battery 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 |
| 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 |
| Heart rate | Heart rate collected unobtrusively from smartwatch of patient to measure stress | Continuous throughout 12 months |
| Beat-to-beat intervals | Beat-to-beat intervals collected unobtrusively from smartwatch of patient to measure stress | 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) |
| Medical history |
| 12 months (follow-up every 3 months) |
| Joint count | 66/68 joint count for swelling and tenderness. Higher count indicates higher swollen/tender joints. | 12 months (follow-up every 3 months) |
| Enthesitis | 6 tendon count for enthesitis using Leeds Enthesitis Index | 12 months (follow-up every 3 months) |
| Body surface area | Body Surface Area for skin | 12 months (follow-up every 3 months) |
| Weight | Weight (kg) to calculate body mass index (BMI) | Baseline |
| Height | Height (cm) to calculate BMI | Baseline |
| Abdominal circumference | Abdominal circumference (cm) | Baseline |
| ClASsification criteria for Psoriatic ARthritis (CASPAR) score | CASPAR score calculation for the classification of PsA using points from the following criteria: (i) evidence of current psoriasis, or personal or family history of psoriasis, (ii) dactylitis, (iii) juxtaarticular new bone formation, (iv) nail dystrophy, and (v) negative for rheumatoid factor. | Baseline |
| Demographics | Questionnaire to assess demographics | 12 months (follow-up every 3 months) |
| VAS Pain | VAS for pain assessment. Higher score indicate higher pain levels. | 12 months (follow-up every 3 months) |
| HAQ questionnaire | HAQ questionnaire to measure physical function | 12 months (follow-up every 3 months) |
| VAS patient global | VAS for patient global assessment | 12 months (follow-up every 3 months) |
| PSAID questionnaire | PSAID questionnaire to measure impact of disease. Higher score indicates higher impact of disease. | 12 months (follow-up every 3 months) |
| SF-36 questionnaire | SF-36 questionnaire for general health assessment | 12 months (follow-up every 3 months) |
| EQ5d questionnaire | EQ5d questionnaire for general health assessment | 12 months (follow-up every 3 months) |
| Work Productivity and Activity Impairment (WPAI) questionnaire | WPAI questionnaire for work impairment | 12 months (follow-up every 3 months) |
| Health care questionnaire | Health care questionnaire for health care usage | 12 months (follow-up every 3 months) |
| Patient Health Questionnaire (PHQ9) questionnaire | (PHQ9) questionnaire for depression assessment | 12 months (follow-up every 3 months) |
| Perceived Stress Scale (PSS) | PSS questionnaire for stress | 12 months (follow-up every 3 months) |
| Global Rating of Change (GRoC) Scale | GRoC scale to evaluate change in disease activity. | 12 months (follow-up every 3 months) |
| Life events questionnaire | Life events questionnaire for life events | 12 months (Baseline and month 12) |
| Digital literacy questionnaire | Digital literacy questionnaire for technology readiness | Baseline |
| Inflammatory blood marker | Blood C-reactive protein levels (ml/L) | 12 months (follow-up every 3 months) |
| Genetic variants | Salivary DNA analysis | Baseline |
| Gut microbiome | Stool analysis to extract bacterial DNA using 16S sequencing | 12 months (Baseline, in case of flare, and months 6 and 12 in subgroup of patients) |
| Stress (cortisol levels) | Hair cortisol analysis to measure stress | 12 months (follow-up every 3 months) |
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012008 | Recurrence |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |