Clinical trial NCT05578768: Prediction of IBD Disease Activity in Individual Patients Based on PROMs and Clinical Data
Official title: Prediction of IBD Disease Activity in Individual Patients Based on PROMs and Clinical Data
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: IBD
Inflammatory Bone Disease
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Alrijne Hospital
name: Maasstad Hospital
First posted: 2022-10-13
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: After 2 years
measure: Validate the above mentioned prediction model and make it available for daily (remote) care management.
timeFrame: After 2 years
Secondary outcomes:
measure: 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.
timeFrame: After 2 years
measure: Correlate the prediction scores of the different care pathways to medication type.
timeFrame: After 2 years
measure: Correlate prediction scores of the different pathways with biomarkers CRP/Calprotectin and/or endoscopy
timeFrame: After 2 years
measure: Correlate prediction scores from the algorithm with known IBD clinical risk factors
timeFrame: After 2 years
measure: Correlate dietary intake with the assigned IBD clinical risk profiles
timeFrame: After 2 years
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Centre
state: Zuid-Holland
Study officials:
affiliation: Leiden University Medical Centre
name: A.E. van der Meulen - de Jong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: