Prediction of IBD Disease Activity in Individual Patients Based on PROMs and Clinical Data

Last updated: October 12, 2022
Sponsor: Leiden University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Inflammatory Bowel Disease

Bone Diseases

Osteomyelitis

Treatment

N/A

Clinical Study ID

NCT05578768
nWMODIV2_2022020
  • Ages > 18
  • All Genders

Study Summary

The proposed study will use a PROM (Patient report Outcome Measurement)-tool in combination with clinical and biochemical data to train and validate a Relapse Prediction Model for individual patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult IBD patients
  • Subjects willing and able to sign informed consent
  • Own and are able to use a smart phone (Android or iOS)

Exclusion

Exclusion Criteria:

  • Unwilling or unable to adhere to the protocol
  • Unwilling or unable to adhere to the informed consent
  • Age <18y

Study Design

Total Participants: 400
Study Start date:
October 03, 2022
Estimated Completion Date:
September 01, 2025

Study Description

The primary objective is to train and validate a relapse prediction model for individual patients available for daily (remote) care management. Besides that, risk-based care pathways for different prediction outcomes will be evaluated, prediction scores will be correlated to medication type, CRP/Calprotectin and/or endoscopy, and with known IBD clinical risk profiles. Moreover dietary intake will be correlated with the IBD risk profiles.

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.

Connect with a study center

  • Leiden University Medical Centre

    Leiden, Zuid-Holland 2300 RC
    Netherlands

    Active - Recruiting

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