M-TECCU is a study: multicenter, randomized and open. It consists of two parallel groupsto compare the efficacy of the TECCU web-based telemonitoring system to achieve andmaintain activity remission in patients with moderate-high complexity inflammatory boweldisease compared to usual clinical practice.
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.
Other: TECCU Software
patient monitoring by software application
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
Hospital Universitario y Politécnico la Fe
Valencia 2509954, Valencia 2593113, Spain
Hospital Universitario de Alicante
Alicante 2521978, Spain
Hospital Germans Trias i Pujol
Badalona 3129028, Spain
Hospital Universitario de Burgos
Burgos 3127461, Spain
Hospital Universitario de Cabueñes
Cabueñes 3127138, Spain
Hospital Universitario Reina Sofía
Córdoba 2519240, Spain
Hospital de Cruces
Cruces 3124254, Spain
Hospital General Universitario de Elche
Elche 2518559, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada 3121960, Spain
Hospital Trueta de Girona
Girona 3121456, Spain
Hospital Universitario San Cecilio
Granada 2517117, Spain
Hospital de Huelva
Huelva 2516548, Spain
Hospital Gregorio Marañón
Madrid 3117735, Spain
Hospital La Paz
Madrid 3117735, Spain
Hospital La Princesa
Madrid 3117735, Spain
Hospital Puerta del Hierro
Madrid 3117735, Spain
Hospital Ramon y Cajal
Madrid 3117735, Spain
Hospital de Manresa
Manresa 3117533, Spain
Hospital Morales Meseguer
Murcia 2513416, Spain
Hospital Parc Taulí de Sabadell
Sabadell 3111199, Spain
Hospital Infanta Sofía
San Sebastián de los Reyes 3110040, Spain
Hospital Nuestra Señora de la Candelaria
Santa Cruz de Tenerife 2511174, Spain
Hospital Marqués de Valdecilla
Santander 3109718, Spain
Hospital Universitario de Santiago
Santiago de Compostela 3109642, Spain
Consorci Sanitari de Terrassa
Terrassa 3108286, Spain
Hospital Universitario Mutua Terrassa
Terrassa 3108286, Spain
Hospital Clínico Universitario Valencia
Valencia 2509954, Spain
Hospital de Vigo
Vigo 3105976, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza 3104324, Spain
Hospital Universitario Miquel Servet
Zaragoza 3104324, Spain
Mariam Aguas, Principal Investigator
Spanish Working Group on Crohn's disease and ulcerative colitis (GETECCU)