NCT06306261

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
OTHER	questionnaire	UC patients will be subjected to a questionnaire each month about their habits.

Timeline

• Start date: 2024-03-15
• Primary completion: 2024-08-01
• Completion: 2025-03-15
• First posted: 2024-03-12
• Last updated: 2024-03-12

Locations

1 site across 1 country: Italy