Prediction of IBD Disease Activity in Individual Patients Based on PROMs and Clinical Data
NCT ID: NCT05578768
Last Updated: 2022-10-13
Study Results
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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UNKNOWN
400 participants
OBSERVATIONAL
2022-10-03
2025-09-01
Brief Summary
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Detailed Description
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Study design: Multicentre, retrospective analysis of two prospective cohorts. Study population: Adult IBD patients. Main study parameters/endpoints: The endpoint will be a prediction regarding step-up or step-down in the care pathways. In other words, the percentage of patients in each individual care pathway with agreement between risk score of the individual patient and actual flares during a follow-up time of 24 months. Furthermore insight will be gained in dietary patterns amongst patients with different IBD risk profiles.
No benefits or risks are associated with participating in this study, because only standard of care is given.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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training phase
The study procedures for both cohorts are the same.
No intervention
Patients will receive standard of care.
validation phase
The study procedures for both cohorts are the same.
No intervention
Patients will receive standard of care.
Interventions
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No intervention
Patients will receive standard of care.
Eligibility Criteria
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Inclusion Criteria
* Subjects willing and able to sign informed consent
* Own and are able to use a smart phone (Android or iOS)
Exclusion Criteria
* Unwilling or unable to adhere to the informed consent
* Age \<18y
18 Years
ALL
No
Sponsors
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Alrijne Hospital
OTHER
Maasstad Hospital
OTHER
Leiden University Medical Center
OTHER
Responsible Party
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Andrea E. van der Meulen - de Jong, MD, PhD
Principal Investigator
Principal Investigators
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A.E. van der Meulen - de Jong, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Leiden University Medical Centre
Locations
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Leiden University Medical Centre
Leiden, South Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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nWMODIV2_2022020
Identifier Type: -
Identifier Source: org_study_id
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