Clinical trial NCT06347237: PsA Digital Phenotyping and Inflammation Drivers Study
Official title: PsA Digital Phenotyping and Inflammation Drivers Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Psoriatic Arthritis
Flare Up, Symptom
Psoriatic Arthritis Aggravated
Keywords: psoriatic arthritis
inflammation
digital biomarker
flare
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: University of Oxford - Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences
name: Aristotle University Of Thessaloniki
name: Portuguese Society of Rheumatology - The Rheumatic Diseases Portuguese Registry (Reuma.pt)
First posted: 2024-04-04
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with psoriatic arthritis

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


Eligibility criteria: 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

Primary outcomes:
measure: Absence of flare in patients
timeFrame: 12 months (follow-up every 3 months)
Secondary outcomes:
measure: Minimal disease Activity (MDA)
timeFrame: 12 months (follow-up every 3 months)
measure: Psoriatic Arthritis Disease Activity Score (PASDAS)
timeFrame: 12 months (follow-up every 3 months)
measure: Disease Activity Psoriatic Arthritis (DAPSA)
timeFrame: 12 months (follow-up every 3 months)
measure: Psoriatic Arthritis Impact of Disease (PsAID)
timeFrame: 12 months (follow-up every 3 months)
measure: Morning stiffness
timeFrame: 12 months (follow-up every 3 months)
Other outcomes:
measure: Keystroke dynamics
timeFrame: Continuous throughout 12 months
measure: Screen time
timeFrame: Continuous throughout 12 months
measure: Accelerometer data
timeFrame: Continuous throughout 12 months
measure: Gyroscope sensor data
timeFrame: Continuous throughout 12 months
measure: Steps count
timeFrame: Continuous throughout 12 months
measure: Physical activity intensity and categories
timeFrame: Continuous throughout 12 months
measure: Motion
timeFrame: Continuous throughout 12 months
measure: Distance
timeFrame: Continuous throughout 12 months
measure: Pulse Ox
timeFrame: Continuous throughout 12 months
measure: Respiration
timeFrame: Continuous throughout 12 months
measure: Body battery
timeFrame: Continuous throughout 12 months
measure: Stress (digital)
timeFrame: Continuous throughout 12 months
measure: Heart rate
timeFrame: Continuous throughout 12 months
measure: Beat-to-beat intervals
timeFrame: Continuous throughout 12 months
measure: Sleeping time
timeFrame: Continuous throughout 12 months
measure: Sleeping type
timeFrame: Continuous throughout 12 months
measure: Hand and feet photos
timeFrame: 12 months (follow-up every 6 weeks and in case of flare)
measure: Hand and body movements videos
timeFrame: 12 months (follow-up every 6 weeks and in case of flare)
measure: Medical history
timeFrame: 12 months (follow-up every 3 months)
measure: Joint count
timeFrame: 12 months (follow-up every 3 months)
measure: Enthesitis
timeFrame: 12 months (follow-up every 3 months)
measure: Body surface area
timeFrame: 12 months (follow-up every 3 months)
measure: Weight
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Abdominal circumference
timeFrame: Baseline
measure: ClASsification criteria for Psoriatic ARthritis (CASPAR) score
timeFrame: Baseline
measure: Demographics
timeFrame: 12 months (follow-up every 3 months)
measure: VAS Pain
timeFrame: 12 months (follow-up every 3 months)
measure: HAQ questionnaire
timeFrame: 12 months (follow-up every 3 months)
measure: VAS patient global
timeFrame: 12 months (follow-up every 3 months)
measure: PSAID questionnaire
timeFrame: 12 months (follow-up every 3 months)
measure: SF-36 questionnaire
timeFrame: 12 months (follow-up every 3 months)
measure: EQ5d questionnaire
timeFrame: 12 months (follow-up every 3 months)
measure: Work Productivity and Activity Impairment (WPAI) questionnaire
timeFrame: 12 months (follow-up every 3 months)
measure: Health care questionnaire
timeFrame: 12 months (follow-up every 3 months)
measure: Patient Health Questionnaire (PHQ9) questionnaire
timeFrame: 12 months (follow-up every 3 months)
measure: Perceived Stress Scale (PSS)
timeFrame: 12 months (follow-up every 3 months)
measure: Global Rating of Change (GRoC) Scale
timeFrame: 12 months (follow-up every 3 months)
measure: Life events questionnaire
timeFrame: 12 months (Baseline and month 12)
measure: Digital literacy questionnaire
timeFrame: Baseline
measure: Inflammatory blood marker
timeFrame: 12 months (follow-up every 3 months)
measure: Genetic variants
timeFrame: Baseline
measure: Gut microbiome
timeFrame: 12 months (Baseline, in case of flare, and months 6 and 12 in subgroup of patients)
measure: Stress (cortisol levels)
timeFrame: 12 months (follow-up every 3 months)
Locations:
Study officials:
References: