PsA Digital Phenotyping and Inflammation Drivers Study
- Conditions
- Psoriatic Arthritis AggravatedFlare Up, SymptomPsoriatic Arthritis
- Registration Number
- NCT06347237
- Lead Sponsor
- Jolanda Luime
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 600
- Diagnosed with PsA
- Age 18 years or older and competent
- Using a smartphone
- Agree to use smartwatch
- Good command of the local language
- Less than 18 years of age
- Incapacitated
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Morning stiffness 12 months (follow-up every 3 months) Morning stiffness on a 10-point Likert scale. Higher scores indicate higher morning stiffness.
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
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.