This clinical trial aims to evaluate whether GutyCare, a digital remote patient monitoring (RPM) solution, can enhance organizational outcomes while maintaining non-inferior clinical results in patients with inflammatory bowel disease (IBD) who are initiating or undergoing significant modifications in advanced therapy.
The study compares standard care to an intervention involving the use of GutyCare, a mobile application that collects patient-reported outcomes related to symptoms.
When clinically significant symptoms are identified, alerts are transmitted to the care team, facilitating timely and personalized therapeutic adjustments.
Diagnosed with Inflammatory bowel disease, either Crohn's disease or ulcerative colitis, at least 3 months before enrolment
Initiating an advanced therapy (i.e., biologic therapy or small molecule) OR occurrence of a substantial change in the treatment of the disease.
Active disease.
Patients with altered intestinal continuity or function due to major abdominal surgery (e.g., stoma, extensive resection, anastomosis), uncontrolled intra-abdominal abscess, or active perianal disease.
Patients for whom digestive surgery is expected during the study period.
Patients unable or unwilling to use or already using GutyCare.
Vulnerable individuals as defined by French law.
Parallel
GutyCare
DeviceDevice : GutyCare The participants will use GutyCare remote patient monitoring.
Number of on-site IBD-related visits
Clinical remission without corticosteroids
Patients' disease activity
PRO-2
Improvement in quality of life
SIBDQ
Experience from patients
Dedicated questionnaire for patients.
Experience from HCP
Dedicated questionnaire for HCP.
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Resilience
Lead sponsor
Sanoia
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
