Predicting IBD flare-ups using patient-reported outcomes and clinical data
Prediction of IBD Disease Activity in Individual Patients Based on PROMs and Clinical Data
This study is trying to see if combining patient feedback with medical data can help predict flare-ups in people with Inflammatory Bowel Disease (IBD) to improve their daily care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 1 site (Leiden, Zuid-Holland) |
| Trial ID | NCT05578768 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop and validate a relapse prediction model for patients with Inflammatory Bowel Disease (IBD) by utilizing Patient Reported Outcome Measurements (PROMs) alongside clinical and biochemical data. The study will analyze data from two prospective cohorts of adult IBD patients to correlate prediction scores with medication types, inflammatory markers, and dietary intake. The goal is to enhance daily care management through personalized risk-based care pathways over a follow-up period of 24 months.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients diagnosed with Inflammatory Bowel Disease who can provide informed consent and use a smartphone.
Not a fit: Patients under 18 years old or those unable to adhere to the study protocol will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective management of IBD, reducing the frequency and severity of flare-ups.
How similar studies have performed: Other studies have shown promise in using predictive models for chronic conditions, suggesting potential success for this approach in IBD management.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Leiden, Zuid-Holland
- Leiden University Medical Centre — Leiden, Zuid-Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: A.E. van der Meulen - de Jong, MD, PhD — Leiden University Medical Centre
- Study coordinator: L.J.M. Koppelman, Msc.
- Email: patientenibd@lumc.nl
- Phone: 0031715297902
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.