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

Ulcerative Colitis Clinical Trial

— TIMAEUS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06306261
• Other study ID #: TIMAEUS
• Status: Not yet recruiting
• Start date: March 15, 2024
• Est. completion date: March 15, 2025

Study information

• Verified date: March 2024
• Source: IRCCS San Raffaele
• Contact: Silvio Danese
• Phone: 0226439494
• Email: ibd.trials[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: March 15, 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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

Locations

Country	Name	City	State
Italy	Irccs Ospedale San Raffaele	Milano

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to evaluate mental stress/health as an impacting factor on UC progression	The enrolled UC patients should compile a questionnaire which asks about feelings and thoughts.; The questionnaire will be the Italian version of the Perceived Stress Scale (PSS).; The scale goes from 0 to 4.Scoring is reversed for positive questions 0= 4 scores; 1= 3 scores, 2=2 scores; 3=1 score; 4=0. For negative questions are 0 minimum score and 4 maximum score Higher score is considered more stress, so worse outcome, conversely lower score is less stress so better outcome.; Patients will be remembered to answer to questions about their habits though a notification every 30 days in mobile app.	8 months