Flare Up, Symptom, Psoriatic Arthritis, Psoriatic Arthritis Aggravated
Conditions
Keywords
psoriatic arthritis, inflammation, digital biomarker, flare
Brief summary
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: * In patients with psoriatic arthritis, is a digital biomarker capable of detecting a flare as compared to clinical defined flare by the rheumatologist? * In patients with psoriatic arthritis, what factors trigger a psoriatic arthritis flare ? Participants will be requested to: * Install app on their phone * Use a smartwatch * Complete questionnaires * Collect biological material
Interventions
None listed
Sponsors
University of Oxford - Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences
Aristotle University Of Thessaloniki
Portuguese Society of Rheumatology - The Rheumatic Diseases Portuguese Registry (Reuma.pt)
Jolanda Luime
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Diagnosed with PsA * Age 18 years or older and competent * Using a smartphone * Agree to use smartwatch * Good command of the local language
Exclusion criteria
* Less than 18 years of age * Incapacitated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absence of flare in patients | 12 months (follow-up every 3 months) | Flare in psoriatic arthritis evaluated as: Patients * 'At this time, is your psoriatic arthritis in remission, if this means: you feel your disease is as good as gone?' yes/ no (for remission) * 'At this time, are you in low disease activity, if this means: your disease is in low activity but it's not as good as gone?' yes/ no (for low disease activity) 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 * 'At this time, is the psoriatic arthritis in remission, if this means: the absence of clinical and laboratory evidence of significant inflammatory disease activity?' yes/ no (for remission) * 'At this time, is the psoriatic arthritis in low or minimal disease activity?' yes/ no (for low disease activity) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minimal disease Activity (MDA) | 12 months (follow-up every 3 months) | 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 |
| Psoriatic Arthritis Disease Activity Score (PASDAS) | 12 months (follow-up every 3 months) | 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. |
| Disease Activity Psoriatic Arthritis (DAPSA) | 12 months (follow-up every 3 months) | 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. |
| Psoriatic Arthritis Impact of Disease (PsAID) | 12 months (follow-up every 3 months) | 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. |
| Morning stiffness | 12 months (follow-up every 3 months) | Morning stiffness on a 10-point Likert scale. Higher scores indicate higher morning stiffness. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Keystroke dynamics | Continuous throughout 12 months | Keypad time-related data and metadata collected unobtrusively from smartphone of patient |
| Screen time | Continuous throughout 12 months | Screen time (hours) metrics collected unobtrusively from smartphone of patient |
| Accelerometer data | Continuous throughout 12 months | Accelerometer data collected unobtrusively from smartphone of patient and smartwatch to measure physical activity. Patients will wear the smartwatch daily |
| Gyroscope sensor data | Continuous throughout 12 months | Gyroscope sensor data for orientation collected unobtrusively from smartphone of patient |
| Steps count | Continuous throughout 12 months | Count of steps collected unobtrusively from the smartwatch of patient to measure physical activity. Patients will wear the smartwatch daily |
| Physical activity intensity and categories | Continuous throughout 12 months | 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 |
| Motion | Continuous throughout 12 months | 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 |
| Distance | Continuous throughout 12 months | Distance (km) collected unobtrusively from smartwatch of patient to measure physical activity. Patients will wear the smartwatch daily |
| Pulse Ox | Continuous throughout 12 months | Pulse Ox collected unobtrusively from smartwatch of patient to measure physical activity. Patients will wear the smartwatch daily |
| Respiration | Continuous throughout 12 months | Respiration rate collected unobtrusively from smartwatch of patient to measure physical activity. Patients will wear the smartwatch daily |
| Body battery | Continuous throughout 12 months | 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 |
| Stress (digital) | Continuous throughout 12 months | 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 |
| Heart rate | Continuous throughout 12 months | Heart rate collected unobtrusively from smartwatch of patient to measure stress |
| Beat-to-beat intervals | Continuous throughout 12 months | Beat-to-beat intervals collected unobtrusively from smartwatch of patient to measure stress |
| Sleeping time | Continuous throughout 12 months | Sleeping time (hours) collected unobtrusively from smartwatch of patient |
| Sleeping type | Continuous throughout 12 months | Sleeping type (%) collected unobtrusively from smartwatch of patient |
| HAQ questionnaire | 12 months (follow-up every 3 months) | HAQ questionnaire to measure physical function |
| VAS patient global | 12 months (follow-up every 3 months) | VAS for patient global assessment |
| Hand and body movements videos | 12 months (follow-up every 6 weeks and in case of flare) | 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 |
| Medical history | 12 months (follow-up every 3 months) | * Age (years) * Sex * Years of disease (years) * Medication over the year of the study * Comorbidity * Care activities * Job title, shift work * Frequent flying (days) |
| Joint count | 12 months (follow-up every 3 months) | 66/68 joint count for swelling and tenderness. Higher count indicates higher swollen/tender joints. |
| Enthesitis | 12 months (follow-up every 3 months) | 6 tendon count for enthesitis using Leeds Enthesitis Index |
| Body surface area | 12 months (follow-up every 3 months) | Body Surface Area for skin |
| Weight | Baseline | Weight (kg) to calculate body mass index (BMI) |
| Height | Baseline | Height (cm) to calculate BMI |
| Abdominal circumference | Baseline | Abdominal circumference (cm) |
| ClASsification criteria for Psoriatic ARthritis (CASPAR) score | Baseline | 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. |
| Demographics | 12 months (follow-up every 3 months) | Questionnaire to assess demographics |
| VAS Pain | 12 months (follow-up every 3 months) | VAS for pain assessment. Higher score indicate higher pain levels. |
| Patient Health Questionnaire (PHQ9) questionnaire | 12 months (follow-up every 3 months) | (PHQ9) questionnaire for depression assessment |
| Perceived Stress Scale (PSS) | 12 months (follow-up every 3 months) | PSS questionnaire for stress |
| Global Rating of Change (GRoC) Scale | 12 months (follow-up every 3 months) | GRoC scale to evaluate change in disease activity. |
| Life events questionnaire | 12 months (Baseline and month 12) | Life events questionnaire for life events |
| Digital literacy questionnaire | Baseline | Digital literacy questionnaire for technology readiness |
| Inflammatory blood marker | 12 months (follow-up every 3 months) | Blood C-reactive protein levels (ml/L) |
| Genetic variants | Baseline | Salivary DNA analysis |
| Gut microbiome | 12 months (Baseline, in case of flare, and months 6 and 12 in subgroup of patients) | Stool analysis to extract bacterial DNA using 16S sequencing |
| SF-36 questionnaire | 12 months (follow-up every 3 months) | SF-36 questionnaire for general health assessment |
| Stress (cortisol levels) | 12 months (follow-up every 3 months) | Hair cortisol analysis to measure stress |
| EQ5d questionnaire | 12 months (follow-up every 3 months) | EQ5d questionnaire for general health assessment |
| Work Productivity and Activity Impairment (WPAI) questionnaire | 12 months (follow-up every 3 months) | WPAI questionnaire for work impairment |
| Health care questionnaire | 12 months (follow-up every 3 months) | Health care questionnaire for health care usage |
| Hand and feet photos | 12 months (follow-up every 6 weeks and in case of flare) | 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 |
| PSAID questionnaire | 12 months (follow-up every 3 months) | PSAID questionnaire to measure impact of disease. Higher score indicates higher impact of disease. |
Outcome results
None listed