Status:
ACTIVE_NOT_RECRUITING
Impact of Telemonitoring in the Management of Complex IBD in Spain: M-TECCU
Lead Sponsor:
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Conditions:
Inflammatory Bowel Disease
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT06031038
Start Date
September 15 2020
End Date
June 30 2025
Last Update
April 17 2025
Active Locations (30)
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1
Hospital Universitario y Politécnico la Fe
Valencia, Valencia, Spain, 46026
2
Hospital Universitario de Alicante
Alicante, Spain
3
Hospital Germans Trias i Pujol
Badalona, Spain
4
Hospital Universitario de Burgos
Burgos, Spain