Randomized Controlled Trial Comparing Remote Patient Monitoring vs Standard Care in IBD Patients Initiating or Changing Advanced Therapy

Overview

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.

GutyCare is a digital medical device (dMD, CE marked, class IIa) that enables the remote monitoring of patients diagnosed with Inflammatory Bowel Disease (IBD). GutyCare is a software medical device prescribed by gastroenterologists to collect electronic patient-reported outcomes (ePRO). The workflow of GutyCare includes the following steps: * Collection of ePRO * Intelligent analysis and alerts * Adapted care

Conditions

Interventions