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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Other: questionnaire

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Silvio Danese; Phone Number: 0226439494; Email: ibd.trials@hsr.it

Study Locations

• Italy
  • Milano, Italy, 20132
    • Irccs Ospedale San Raffaele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

150 patients affected by UC under the standard of care protocols at OSR, will be subjected to a questionnaire each 30 days about their habits.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients in remission of the disease; UC patients will be subjected to a questionnaire every month about their habits.	Other: questionnaire; 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.	Other: questionnaire; UC patients will be subjected to a questionnaire each month about their habits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): March 15, 2025

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: TIMAEUS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No