Impact of Telemonitoring in the Management of Complex IBD in Spain: M-TECCU
M-TECCU
1 other identifier
interventional
290
1 country
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2020
Longer than P75 for not_applicable
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 13, 2021
CompletedFirst Submitted
Initial submission to the registry
July 24, 2023
CompletedFirst Posted
Study publicly available on registry
September 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 5, 2025
CompletedFebruary 6, 2026
February 1, 2026
1.1 years
July 24, 2023
February 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
clinical remission
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.
52 weeks
Secondary Outcomes (1)
cost-effectiveness
52 weeks
Study Arms (2)
Control group
NO INTERVENTIONPatients receive conventional care in the outpatient clinics of the participating specialized IBD units in Spain. This is complemented with telephone controls for those aspects that can be controlled by this means according to standard clinical practice. Likewise, an individual assessment will be made if, after the situation generated by SARS-COV2, any participating center should have to modify face-to-face consultations for telephone consultations, following the usual clinical practice at all times.
Web telemonitoring group (G_TECCU)
ACTIVE COMPARATORMonitoring and control will be done remotely through the TECCU comprehensive management platform, configured to respond to the specific needs of IBD patients. Patients will connect to the internet from a computer or an APP application on a tablet or mobile terminal, Android or iOS. They will have to complete questionnaires related to the variables under study at each control according to a pre-established follow-up plan. During the follow-up, the number of controls may be increased (intensive monitoring) according to the evolution of the patient, who in turn will be able to perform controls on demand. The healthcare personnel of each IBD unit will receive the information of each patient filtered through an intelligent alert generation system from which an integrated intervention protocol will be followed to adjust the treatment and follow-up plan in each case.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Hospital Universitario y Politécnico la Fe
Valencia, Valencia, 46026, Spain
Hospital Universitario de Alicante
Alicante, Spain
Hospital Germans Trias i Pujol
Badalona, Spain
Hospital Universitario de Burgos
Burgos, Spain
Hospital Universitario de Cabueñes
Cabueñes, Spain
Hospital Universitario Reina Sofía
Córdoba, Spain
Hospital de Cruces
Cruces, Spain
Hospital General Universitario de Elche
Elche, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Spain
Hospital Trueta de Girona
Girona, Spain
Hospital Universitario San Cecilio
Granada, Spain
Hospital de Huelva
Huelva, Spain
Hospital Gregorio Marañón
Madrid, Spain
Hospital La Paz
Madrid, Spain
Hospital La Princesa
Madrid, Spain
Hospital Puerta del Hierro
Madrid, Spain
Hospital Ramon y Cajal
Madrid, Spain
Hospital de Manresa
Manresa, Spain
Hospital Morales Meseguer
Murcia, Spain
Hospital Parc Taulí de Sabadell
Sabadell, Spain
Hospital Infanta Sofía
San Sebastián de los Reyes, Spain
Hospital Nuestra Señora de la Candelaria
Santa Cruz de Tenerife, Spain
Hospital Marqués de Valdecilla
Santander, Spain
Hospital Universitario de Santiago
Santiago de Compostela, Spain
Consorci Sanitari de Terrassa
Terrassa, Spain
Hospital Universitario Mutua Terrassa
Terrassa, Spain
Hospital Clínico Universitario Valencia
Valencia, Spain
Hospital de Vigo
Vigo, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain
Hospital Universitario Miquel Servet
Zaragoza, Spain
Related Publications (4)
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.
PMID: 30482739BACKGROUNDAguas 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.
PMID: 30578197BACKGROUNDDel 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.
PMID: 33339564BACKGROUNDAguas M, Del Hoyo J, Vicente R, Barreiro-de Acosta M, Melcarne L, Hernandez-Camba A, Madero L, Arroyo MT, Sicilia B, Chaparro M, Martin-Arranz MD, Pajares R, Mesonero F, Manosa M, Martinez P, Chacon S, Tosca J, Marin S, Sanroman L, Calvo M, Monfort D, Saiz E, Zabana Y, Guerra I, Varela P, Baydal V, Faubel R, Corsino P, Porto-Silva S, Brunet E, Gonzalez M, Gutierrez A, Nos P. Telemonitoring of Active Inflammatory Bowel Disease Using the App TECCU: Short-Term Results of a Multicenter Trial of GETECCU. J Med Internet Res. 2024 Nov 18;26:e60966. doi: 10.2196/60966.
PMID: 39189160DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mariam Aguas
Spanish Working Group on Crohn's disease and ulcerative colitis (GETECCU)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2023
First Posted
September 11, 2023
Study Start
September 15, 2020
Primary Completion
October 13, 2021
Study Completion
June 5, 2025
Last Updated
February 6, 2026
Record last verified: 2026-02