Clinical trial NCT06031038: Impact of Telemonitoring in the Management of Complex IBD in Spain: M-TECCU
Official title: Impact of Telemonitoring in the Management of Complex Inflammatory Bowel Disease in Spain: TECCU Multicenter Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Telemedicine
Lead sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: clinical remission
timeFrame: 52 weeks
Secondary outcomes:
measure: cost-effectiveness
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Hospital Universitario de Alicante
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Cabueñes
country: Spain
facility: Hospital Universitario de Cabueñes
city: Cruces
country: Spain
facility: Hospital de Cruces
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
city: Girona
country: Spain
facility: Hospital Trueta de Girona
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio
city: Huelva
country: Spain
facility: Hospital de Huelva
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital La Paz
city: Madrid
country: Spain
facility: Hospital La Princesa
city: Madrid
country: Spain
facility: Hospital Puerta del Hierro
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Manresa
country: Spain
facility: Hospital de Manresa
city: Murcia
country: Spain
facility: Hospital Morales Meseguer
city: Sabadell
country: Spain
facility: Hospital Parc Taulí de Sabadell
city: San Sebastián de los Reyes
country: Spain
facility: Hospital Infanta Sofía
city: Santa cruz de Tenerife
country: Spain
facility: Hospital Nuestra Señora de la Candelaria
city: Santander
country: Spain
facility: Hospital Marqués de Valdecilla
city: Santiago de compostela
country: Spain
facility: Hospital Universitario de Santiago
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
city: Terrassa
country: Spain
facility: Hospital Universitario Mutua Terrassa
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico la Fe
city: Valencia
country: Spain
facility: Hospital Clínico Universitario Valencia
city: Vigo
country: Spain
facility: Hospital de Vigo
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Universitario Miquel Servet
Study officials:
affiliation: Spanish Working Group on Crohn's disease and ulcerative colitis (GETECCU)
name: Mariam Aguas
role: PRINCIPAL_INVESTIGATOR
References:
citation: Del Hoyo J, Nos P, Faubel R, Munoz D, Dominguez D, Bastida G, Valdivieso B, Correcher M, Aguas M. A Web-Based Telemanagement System for Improving Disease Activity and Quality of Life in Patients With Complex Inflammatory Bowel Disease: Pilot Randomized Controlled Trial. J Med Internet Res. 2018 Nov 27;20(11):e11602. doi: 10.2196/11602.
citation: Aguas M, Del Hoyo J, Faubel R, Munoz D, Dominguez D, Bastida G, Navarro B, Barrios A, Valdivieso B, Correcher M, Nos P. A Web-Based Telemanagement System for Patients With Complex Inflammatory Bowel Disease: Protocol for a Randomized Controlled Clinical Trial. JMIR Res Protoc. 2018 Dec 21;7(12):e190. doi: 10.2196/resprot.9639.
citation: Del Hoyo J, Aguas M. Cost-effectiveness of Telemedicine-directed Specialized vs Standard Care for Patients With Inflammatory Bowel Diseases in a Randomized Trial. Clin Gastroenterol Hepatol. 2021 Jan;19(1):206-207. doi: 10.1016/j.cgh.2020.06.016. No abstract available.