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

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.

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