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

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.

Study Overview

• Status: Recruiting
• Conditions: IBD; Inflammatory Bone Disease
• Intervention / Treatment: Other: No intervention

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: L.J.M. Koppelman, Msc.; Phone Number: 0031715297902; Email: patientenibd@lumc.nl

Study Locations

• Netherlands
  • Zuid-Holland
    • Leiden, Zuid-Holland, Netherlands, 2300 RC
      • Recruiting
      • Leiden University Medical Centre
      • Contact: L.J.M. Koppelman, MSc; Phone Number: 0031715297902; Email: patientenibd@lumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
training phase; The study procedures for both cohorts are the same.	Other: No intervention; Patients will receive standard of care.
validation phase; The study procedures for both cohorts are the same.	Other: No intervention; Patients will receive standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Evaluate whether predefined risk-based care pathways are in line with prediction outcomes of the relapse prediction model.	After 2 years
Correlate the prediction scores of the different care pathways to medication type.	See if there is a statistical correlation between medication type and prediction score	After 2 years
Correlate prediction scores of the different pathways with biomarkers CRP/Calprotectin and/or endoscopy	See if there is a statistical correlation between prediction score and biomarkers CRP/Calprotectin and/or endoscopy	After 2 years
Correlate prediction scores from the algorithm with known IBD clinical risk factors	See if there is a statistical correlation between prediction scores from the model to known clinical risk factors like e.g. operation history, presence of EIM.	After 2 years
Correlate dietary intake with the assigned IBD clinical risk profiles	See if there is a statistical correlation between dietary intake and assigned IBD clinical risk profile.	After 2 years

Collaborators and Investigators

• Sponsor: Leiden University Medical Center
• Collaborators: Maasstad Hospital; Alrijne Hospital
• Investigators: Principal Investigator: A.E. van der Meulen - de Jong, MD, PhD, Leiden University Medical Centre

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2022
• Primary Completion (Anticipated): September 1, 2025
• Study Completion (Anticipated): September 1, 2025

Study Registration Dates

• First Submitted: August 17, 2022
• First Submitted That Met QC Criteria: October 12, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 12, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Osteitis
• Other Study ID Numbers: nWMODIV2_2022020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No