Ulcerative ColitisTIMAEUSNCT06306261
Controlling the Mental Health for a Better Response to Treatment in Patients With Ulcerative Colitis
An observational study of Ulcerative Colitis, run by IRCCS San Raffaele at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- questionnaire
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 15 Mar 2024to 15 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients in whom the ulcerative colitis has not been diagnosed. All those who have not signed previously informed consensus.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Ulcerative Colitis
- Being tested
- questionnaire
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
UC patients will be subjected to a questionnaire each month about their habits.
| Study group | Role | What they receive |
|---|---|---|
| patients in remission of the disease | UC patients will be subjected to a questionnaire every month about their habits. Receives: Other: questionnaire | |
| patients in reactivation of the disease | UC patients will be subjected to a questionnaire every month about their habits. Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start15 Mar 2024 (estimated)
- Primary completionAug 2024 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvio Danese, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306261
- Sponsor's protocol ID
- TIMAEUS
- Acronym
- TIMAEUS
- Status last verified
- Mar 2024
- First submitted
- 20 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlling the Mental Health for a Better Response to Treatment in Patients With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT06306261
- Acronym / sponsor ID
- TIMAEUS / TIMAEUS
- Conditions
- Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients in remission of the disease | – | Other: questionnaireUC patients will be subjected to a questionnaire every month about their habits. |
| patients in reactivation of the disease | – | Other: questionnaireUC patients will be subjected to a questionnaire every month about their habits. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients in whom the ulcerative colitis has not been diagnosed. All those who have not signed previously informed consensus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaireUC patients will be subjected to a questionnaire each month about their habits. | Other | patients in reactivation of the disease, patients in remission of the disease |
Primary outcome
to evaluate mental stress/health as an impacting factor on UC progression
Time frame: 8 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvio Danese (0226439494, ibd.trials@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to evaluate mental stress/health as an impacting factor on UC progression (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.