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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-15

Study Completion Date

2025-03-15

Brief Summary

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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.

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Detailed Description

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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

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Ulcerative Colitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients in remission of the disease

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

questionnaire

Intervention Type OTHER

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

patients in reactivation of the disease

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

questionnaire

Intervention Type OTHER

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

Interventions

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questionnaire

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

Intervention Type OTHER

Eligibility Criteria

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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.