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

Recruiting

• Conditions: IBD; Inflammatory Bone Disease
• Interventions: Other: No intervention

• Registration Number: NCT05578768
• Lead Sponsor: Leiden University Medical Center

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.

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 Timeline

• Study First Submitted: 2022-08-17
• Status Verified: 2022-10
• Study Start: 2022-10-03
• Study First Submitted QC: 2022-10-12
• Last Update Submitted: 2022-10-12
• Study First Posted: 2022-10-13
• Last Update Posted: 2022-10-13
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
training phase	No intervention	The study procedures for both cohorts are the same.
validation phase	No intervention	The study procedures for both cohorts are the same.

Primary Outcome Measures

Name	Time	Method
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.	After 2 years	This model will be based on both clinical parameters and biochemical parameters in the individual care pathways.
Validate the above mentioned prediction model and make it available for daily (remote) care management.	After 2 years	Based on the information form the validation cohort. The model will be validated retrospectively.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Leiden University Medical Centre; 🇳🇱 Leiden, Zuid-Holland, Netherlands