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

Ulcerative Colitis Clinical Trial

— M-TECCU  

Official title:

Impact of Telemonitoring in the Management of Complex Inflammatory Bowel Disease in Spain: TECCU Multicenter Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06031038
• Other study ID #: M-TECCU
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: April 30, 2024

Study information

• Verified date: July 2023
• Source: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 290
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Telemedicine
• Ulcerative Colitis

Intervention

Other:
• TECCU Software
patient monitoring by software application

Locations

Country	Name	City	State
Spain	Hospital Universitario y Politécnico la Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	cost-effectiveness	Carry out a cost-effectiveness analysis based on the direct and indirect costs generated during the 12-month follow-up in G_TECCU and G_control.	52 weeks