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

NCT ID: NCT06031038

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 290 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-15
• Study Completion Date: 2025-06-30

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.

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.

Conditions

Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis; Telemedicine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control group

Patients 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Web telemonitoring group (G_TECCU)

Monitoring 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.

Group Type: ACTIVE_COMPARATOR

TECCU Software

Intervention Type: OTHER

patient monitoring by software application

Interventions

TECCU Software

patient monitoring by software application

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mariam Aguas

Role: PRINCIPAL_INVESTIGATOR

Spanish Working Group on Crohn's disease and ulcerative colitis (GETECCU)

Locations

Hospital Universitario y Politécnico la Fe

Valencia, Valencia, 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

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 30482739 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30578197 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33339564 (View on PubMed)

Aguas 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.

Reference Type: DERIVED

PMID: 39189160 (View on PubMed)

Other Identifiers

M-TECCU

Identifier Type: -

Identifier Source: org_study_id