Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2025-12-17 @ 2:34 AM
Study NCT ID:
NCT06031038
Status:
None
Last Update Posted:
2025-04-17 00:00:00
First Post:
2023-07-24 00:00:00
Brief Title:
Impact of Telemonitoring in the Management of Complex IBD in Spain: M-TECCU
Sponsor:
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Organization:
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Study Overview
Official Title:
Impact of Telemonitoring in the Management of Complex Inflammatory Bowel Disease in Spain: TECCU Multicenter Study
Status:
None
Status Verified Date:
2025-04
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:
M-TECCU
Brief Summary:
Clinical trial with an open, randomized and controlled non-inferiority medical device, in which the impact of a follow-up method through a web telemonitoring platform on the time in clinical remission of patients with complex IBD is evaluated, in comparison with the usual follow-up in outpatient clinics.
Patients with complex IBD are considered to be those who receive treatment with immunosuppressants or biological therapies to control the luminal activity of their disease. Patients carry out periodic controls for the disease according to a pre-established schedule based on national and international clinical guidelines. The patients in the telemonitoring group (G\_TECCU) follow these controls through the TECCU platform, a web system that allows them to fill in questionnaires related to the clinical variables under study and communicate freely with healthcare personnel during pre-established controls and when the patient deems it necessary. On the other hand, the patients of the control group (G\_Control) carry out the controls according to the same schedule as G\_TECCU, but following the usual clinical practice.
Patients with complex IBD are considered to be those who receive treatment with immunosuppressants or biological therapies to control the luminal activity of their disease. Patients carry out periodic controls for the disease according to a pre-established schedule based on national and international clinical guidelines. The patients in the telemonitoring group (G\_TECCU) follow these controls through the TECCU platform, a web system that allows them to fill in questionnaires related to the clinical variables under study and communicate freely with healthcare personnel during pre-established controls and when the patient deems it necessary. On the other hand, the patients of the control group (G\_Control) carry out the controls according to the same schedule as G\_TECCU, but following the usual clinical practice.
Detailed Description:
Clinical trial with an open randomized and controlled non-inferiority medical device in which the impact of a follow-up method through a web telemonitoring platform on the time in clinical remission of patients with complex IBD is evaluated in comparison with the usual follow-up in outpatient clinics
Patients with complex IBD are considered to be those who receive treatment with immunosuppressants or biological therapies to control the luminal activity of their disease Patients carry out periodic controls for the disease according to a pre-established schedule based on national and international clinical guidelines The patients in the telemonitoring group G_TECCU follow these controls through the TECCU platform a web system that allows them to fill in questionnaires related to the clinical variables under study and communicate freely with healthcare personnel during pre-established controls and when the patient deems it necessary On the other hand the patients of the control group G_Control carry out the controls according to the same schedule as G_TECCU but following the usual clinical practice
Patients with complex IBD are considered to be those who receive treatment with immunosuppressants or biological therapies to control the luminal activity of their disease Patients carry out periodic controls for the disease according to a pre-established schedule based on national and international clinical guidelines The patients in the telemonitoring group G_TECCU follow these controls through the TECCU platform a web system that allows them to fill in questionnaires related to the clinical variables under study and communicate freely with healthcare personnel during pre-established controls and when the patient deems it necessary On the other hand the patients of the control group G_Control carry out the controls according to the same schedule as G_TECCU but following the usual clinical practice
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