Multiple Digital Biomarkers for Optimization of IBD Care (LEGEND-IBD)

Imelda GI Clinical Research Center

Status: Not yet enrolling

Conditions: Inflammatory Bowel Disease (IBD); Ulcerative Colitis (UC); Crohn Disease (CD)

Treatments: Device: monitoring of wearable data, shopping data, biomarkers and patient reported outcomes

Study type: Observational

Funder types: Other

Identifiers

NCT07159776

imelda 202501

Details and patient eligibility

About

To develop digital biomarkers associated with disease activity of inflammatory bowel disease

Full description

The trial aims to develop digital biomarkers based on a large dataset of imput data. These data come from diffent sources including wearable data, grocery shopping data, patient reported outcome data, laboratory data and technical exam data. A model will be build that predict disease activity in IBD.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females aged > 18 years
• Diagnosis of CD, UC or IBD-unspecified for at least 1 month
• Treatment with conventional or advanced therapy for IBD at initiation of the study
• The patient must have access to an email address
• The patient must be willing to perform all the groceries shopping at any of the Colruyt Group stores during this study, using an Xtra card created by the study team.
• Capacity to independently answer regular digital questionnaires
• Capacity and willingness to use a smartphone and activity tracker

Exclusion criteria

• Planned extended (> 1 month) overseas travel during the study period of 12 months, if internet access would be impossible, inconvenient or unaffordable during this time
• Previous colectomy
• Inability to communicate well with investigators or unable to comply with the study requirements
• Significant medical condition interfering with physiological measurements trough a wearable device (heart failure, pacemaker or defibrillator)
• Inclusion or planned inclusion in an interventional IBD-related clinical trial

Trial design

80 participants in 1 patient group

Patients with IBD

Description:

1. Patients with IBD in longstanding remission (\>2 years) (maximum of 20 patients) 2. Patients with IBD recent event (diagnosis or flare of IBD) (\<1year) (minimum 20 patients) 3. Additional patients with IBD in standard follow up.

Treatment:

Device: monitoring of wearable data, shopping data, biomarkers and patient reported outcomes