NCT05578768

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• IBD
• Inflammatory Bone Disease

Interventions

Type	Name	Description
OTHER	No intervention	Patients will receive standard of care.

Timeline

• Start date: 2022-10-03
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2022-10-13
• Last updated: 2022-10-13

Locations

1 site across 1 country: Netherlands