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

Leiden University Medical Center (LUMC)

Status: Enrolling

Conditions: Inflammatory Bone Disease; IBD

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05578768

nWMODIV2_2022020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

400 participants in 2 patient groups

training phase

Description:

The study procedures for both cohorts are the same.

Treatment:

Other: No intervention

validation phase

Description:

The study procedures for both cohorts are the same.

Treatment:

Other: No intervention