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

NCT05578768 | Unknown

• 1 other identifier: nWMODIV2_2022020
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

IBD; Inflammatory Bone Disease

Outcome Measures

Primary Outcomes (2)

• Develop a relapse prediction model for individual patients (agreement between risk score of the individual patient and actual flares) based on both clinical parameters and biochemical parameters in the individual care pathways.

  This model will be based on both clinical parameters and biochemical parameters in the individual care pathways.

  After 2 years

• Validate the above mentioned prediction model and make it available for daily (remote) care management.

  Based on the information form the validation cohort. The model will be validated retrospectively.

  After 2 years

Secondary Outcomes (5)

• evaluate risk-based care pathways for different prediction outcomes in clinical practice e.g. high intensity monitoring care pathway for patients with a high prediction score.

  After 2 years

• Correlate the prediction scores of the different care pathways to medication type.

  After 2 years

• Correlate prediction scores of the different pathways with biomarkers CRP/Calprotectin and/or endoscopy

  After 2 years

• Correlate prediction scores from the algorithm with known IBD clinical risk factors

  After 2 years

• Correlate dietary intake with the assigned IBD clinical risk profiles

  After 2 years

Study Arms (2)

training phase

The study procedures for both cohorts are the same.

Other: No intervention

validation phase

The study procedures for both cohorts are the same.

Other: No intervention

Interventions

No intervention OTHER

Patients will receive standard of care.

training phase; validation phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In clinical practice, consecutive IBD patients in the LUMC, AH, and MH are registered on the platform and will be asked to participate in the current project. At least 200 UC patients and at least 200 CD patients will be included. Following inclusion, each patient will spend at least 12, but preferably 24 months on the platform. Patients are already using the PROM-tool to allow remote monitoring; this has been implemented since 2021.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Alrijne Hospital: collaborator
• Maasstad Hospital: collaborator

Study Sites (1)

Leiden University Medical Centre

Leiden, South Holland, 2300 RC, Netherlands

RECRUITING

MeSH Terms

Conditions

Osteitis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Officials

• A.E. van der Meulen - de Jong, MD, PhD

  Leiden University Medical Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

L.J.M. Koppelman, Msc.

CONTACT

0031715297902; patientenibd@lumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: October 13, 2022
• Study Start: October 3, 2022
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 13, 2022

Record last verified: 2022-10

Locations

NL (1)