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Controlling the Mental Health for a Better Response to Treatment in Patients With Ulcerative Colitis — TIMAEUS  

Ulcerative Colitis Clinical Trial

Official title:
Controlling the Mental Health for a Better Response to Treatment in Patients With Ulcerative Colitis

Clinical Trial Summary

The project aims to implement the Internet Of Thing (IoT) platform of the San Raffaele Hospital (OSR) with data from stress conditions perceived by the patient through the synergistic collaboration between patients, gastroenterologists and psychologists.

Clinical Trial Description

This is a prospective, single-center observational study involving patients with an established diagnosis of UC who are currently receiving standard care and eligible for advanced therapies at the San Raffaele Hospital (OSR). The estimated sample size for the 1-year project is 150 UC patients eligible for advanced therapy. This study aims to understand the relationship between environmental factors, dietary composition, and altered intestinal permeability that contribute to flares in UC patients by leveraging Internet-Of-Things (IoT) technologies. These subjects will be asked to answer a series of questions about feelings and thoughts via the mobile app each month. The mobile app was developed and designed following the open source ResearchKit framework. The questionnaire based on the Perceived Stress Scale (PSS) will be created thanks to the collaboration between the gastroenterologist and psychologists of the San Raffaele Hospital (OSR). The PSS is a classic stress assessment tool. Finally, all this data will be integrated thanks to the bioinformatic tool based on machine learning. All analyzes will be performed and stored in a dedicated cloud service (https://www.heroku.com/), which will make the project feasible and easy to manage. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06306261
Study type Observational
Source IRCCS San Raffaele
Contact Silvio Danese
Phone 0226439494
Email ibd.trials@hsr.it
Status Not yet recruiting
Phase
Start date March 15, 2024
Completion date March 15, 2025
View Details
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