PsA Digital Phenotyping and Inflammation Drivers Study
PDPID
1 other identifier
observational
600
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2024
CompletedFirst Posted
Study publicly available on registry
April 4, 2024
CompletedStudy Start
First participant enrolled
May 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedApril 4, 2024
April 1, 2024
1.6 years
February 14, 2024
April 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Absence of flare in patients
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)
12 months (follow-up every 3 months)
Secondary Outcomes (5)
Minimal disease Activity (MDA)
12 months (follow-up every 3 months)
Psoriatic Arthritis Disease Activity Score (PASDAS)
12 months (follow-up every 3 months)
Disease Activity Psoriatic Arthritis (DAPSA)
12 months (follow-up every 3 months)
Psoriatic Arthritis Impact of Disease (PsAID)
12 months (follow-up every 3 months)
Morning stiffness
12 months (follow-up every 3 months)
Other Outcomes (44)
Keystroke dynamics
Continuous throughout 12 months
Screen time
Continuous throughout 12 months
Accelerometer data
Continuous throughout 12 months
- +41 more other outcomes
Eligibility Criteria
Patients with psoriatic arthritis
You may qualify if:
- Diagnosed with PsA
- Age 18 years or older and competent
- Using a smartphone
- Agree to use smartwatch
- Good command of the local language
You may not qualify if:
- Less than 18 years of age
- Incapacitated
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
February 14, 2024
First Posted
April 4, 2024
Study Start
May 1, 2024
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
April 4, 2024
Record last verified: 2024-04