The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06031038
Recruitment Status : Active, not recruiting
First Posted : September 11, 2023
Last Update Posted : September 11, 2023
Sponsor:
Information provided by (Responsible Party):
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis Telemedicine Other: TECCU Software Not Applicable

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact of Telemonitoring in the Management of Complex Inflammatory Bowel Disease in Spain: TECCU Multicenter Study
Actual Study Start Date : July 1, 2020
Actual Primary Completion Date : April 30, 2023
Estimated Study Completion Date : April 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
No Intervention: control group
Active Comparator: TECCU group Other: TECCU Software
patient monitoring by software application


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. clinical remission [ Time Frame: 52 weeks ]
    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.


Secondary Outcome Measures :
  1. cost-effectiveness [ Time Frame: 52 weeks ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06031038


Locations
Layout table for location information
Spain
Hospital Universitario y Politécnico la Fe
Valencia, Spain, 46026
Sponsors and Collaborators
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Investigators
Layout table for investigator information
Principal Investigator: Castany Pla Spanish Working Group on Crohn's disease and ulcerative colitis (GETECCU)
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
ClinicalTrials.gov Identifier: NCT06031038    
Other Study ID Numbers: M-TECCU
First Posted: September 11, 2023    Key Record Dates
Last Update Posted: September 11, 2023
Last Verified: July 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Intestinal Diseases
Inflammatory Bowel Diseases
 Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases