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

San Donato Group (GSD)

Status: Not yet enrolling

Conditions: Ulcerative Colitis

Treatments: Other: questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT06306261

TIMAEUS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients in whom the ulcerative colitis has been diagnosed and eligible for advanced therapies Patients will be asked to sign an informed consensus before filling out the questionnaire.

Exclusion criteria

• Patients in whom the ulcerative colitis has not been diagnosed. All those who have not signed previously informed consensus.

Trial design

150 participants in 2 patient groups

patients in remission of the disease

Description:

UC patients will be subjected to a questionnaire every month about their habits.

Treatment:

Other: questionnaire

patients in reactivation of the disease

Description:

UC patients will be subjected to a questionnaire every month about their habits.

Treatment:

Other: questionnaire