Impact of Telemonitoring in the Management of Complex IBD in Spain: M-TECCU

Not Applicable

Active, not recruiting

• Conditions: Ulcerative Colitis; Inflammatory Bowel Disease; Telemedicine; Crohn's Disease
• Interventions: Other: TECCU Software

• Registration Number: NCT06031038
• Lead Sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

Brief Summary

M-TECCU is a study: multicenter, randomized and open. It consists of two parallel groups to compare the efficacy of the TECCU web-based telemonitoring system to achieve and maintain activity remission in patients with moderate-high complexity inflammatory bowel disease compared to 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.

Study Timeline

• Study Start: 2020-09-15
• Primary Completion: 2021-10-13
• Study First Submitted: 2023-07-24
• Study First Submitted QC: 2023-09-01
• Study First Posted: 2023-09-11
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

• Patients ≥18a
• IBD (CD or UC) diagnosed according to ECCO criteria
• Start treatment with immunosuppressants and/or biological therapies due to luminal activity
• signed informed consent

Exclusion Criteria

• Pregnant women
• Presence of active perianal disease, ileoanal reservoir, or definitive stoma
• Patients with mental illness or other poorly controlled illness
• Patients with active cancer diagnosis
• Terminal patients and/or palliative care (SECPAL)
• Family members of the research team
• Patients without a telephone line to connect with a mobile, tablet and/or computer / Inability to drive
• Cognitive or linguistic difficulties
• Patients included in another experimental study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TECCU group	TECCU Software	-

Primary Outcome Measures

Name	Time	Method
clinical remission	52 weeks	To compare the time in remission of patients with complex IBD (require immunosuppressants and/or biologics to control their luminal inflammatory activity) controlled with the TECCU intervention (G_TECCU) with respect to usual clinical practice (G_Control) after 52 weeks of follow-up.

Secondary Outcome Measures

Name	Time	Method
cost-effectiveness	52 weeks	Carry out a cost-effectiveness analysis based on the direct and indirect costs generated during the 12-month follow-up in G_TECCU and G_control.

Trial Locations

Locations (30)

Hospital Universitario San Cecilio; 🇪🇸 Granada, Spain

Hospital La Princesa; 🇪🇸 Madrid, Spain

Hospital Puerta del Hierro; 🇪🇸 Madrid, Spain

Hospital Morales Meseguer; 🇪🇸 Murcia, Spain

Hospital Nuestra Señora de la Candelaria; 🇪🇸 Santa cruz de Tenerife, Spain

Hospital Universitario de Santiago; 🇪🇸 Santiago de compostela, Spain

Hospital Universitario de Alicante; 🇪🇸 Alicante, Spain

Hospital Universitario de Burgos; 🇪🇸 Burgos, Spain

Hospital Universitario de Cabueñes; 🇪🇸 Cabueñes, Spain

Hospital Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospital La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario Mutua Terrassa; 🇪🇸 Terrassa, Spain

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Spain

Hospital de Huelva; 🇪🇸 Huelva, Spain

Hospital Ramon y Cajal; 🇪🇸 Madrid, Spain

Hospital Parc Taulí de Sabadell; 🇪🇸 Sabadell, Spain

Hospital de Cruces; 🇪🇸 Cruces, Spain

Hospital Trueta de Girona; 🇪🇸 Girona, Spain

Hospital de Manresa; 🇪🇸 Manresa, Spain

Hospital Marqués de Valdecilla; 🇪🇸 Santander, Spain

Hospital Universitario y Politécnico la Fe; 🇪🇸 Valencia, Spain

Hospital Universitario Reina Sofía; 🇪🇸 Córdoba, Spain

Hospital Universitario de Fuenlabrada; 🇪🇸 Fuenlabrada, Spain

Hospital General Universitario de Elche; 🇪🇸 Elche, Spain

Hospital Clínico Universitario Valencia; 🇪🇸 Valencia, Spain

Hospital Infanta Sofía; 🇪🇸 San Sebastián de los Reyes, Spain

Consorci Sanitari de Terrassa; 🇪🇸 Terrassa, Spain

Hospital Clínico Universitario Lozano Blesa; 🇪🇸 Zaragoza, Spain

Hospital Universitario Miquel Servet; 🇪🇸 Zaragoza, Spain

Hospital de Vigo; 🇪🇸 Vigo, Spain