PsA Digital Phenotyping and Inflammation Drivers Study

NCT ID: NCT06347237

Last Updated: 2024-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-31

Study Completion Date

2025-12-31

Brief Summary

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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:

* 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

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Conditions

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Psoriatic Arthritis Flare Up, Symptom Psoriatic Arthritis Aggravated

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oxford - Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences

UNKNOWN

Sponsor Role collaborator

Aristotle University Of Thessaloniki

OTHER

Sponsor Role collaborator

Portuguese Society of Rheumatology - The Rheumatic Diseases Portuguese Registry (Reuma.pt)

UNKNOWN

Sponsor Role collaborator

Jolanda Luime

OTHER

Sponsor Role lead

Responsible Party

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Jolanda Luime

Principle investigator

Responsibility Role SPONSOR_INVESTIGATOR

Related Links

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https://www.iprolepsis.eu/

iPROLEPSIS project website

Other Identifiers

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NL84429.078.23

Identifier Type: -

Identifier Source: org_study_id

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