Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06306261
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-20
Brief Title:
Controlling the Mental Health for a Better Response to Treatment in Patients With Ulcerative Colitis
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Controlling the Mental Health for a Better Response to Treatment in Patients With Ulcerative Colitis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TIMAEUS
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
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 httpswwwherokucom which will make the project feasible and easy to manage
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 httpswwwherokucom which will make the project feasible and easy to manage
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None