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

NCT06306261 | Not Yet Recruiting

• 1 other identifier: TIMAEUS
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

patients in remission of the disease

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

Other: questionnaire

patients in reactivation of the disease

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

Other: questionnaire

Interventions

questionnaire OTHER

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

patients in reactivation of the disease; patients in remission of the disease

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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.

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

Irccs Ospedale San Raffaele

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Silvio Danese

CONTACT

0226439494; ibd.trials@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professore

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 12, 2024
• Study Start: March 15, 2024
• Primary Completion: August 1, 2024
• Study Completion: March 15, 2025
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

IT (1)