Telemonitoring of Active Inflammatory Bowel Disease Using the App TECCU : Short-Term Results of a Multicenter Trial of GETECCU
Aguas, Mariam (Hospital Universitari i Politècnic La Fe (València))
Del Hoyo, Javier (Hospital Universitari i Politècnic La Fe (València))
Vicente, Raquel (Hospital Universitario Miguel Servet (Saragossa))
Barreiro de-Acosta, Manuel (Hospital Clínico Universitario (Santiago de Compostela, Galícia))
Melcarne, Luigi (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Hernández Camba, Alejandro (Hospital Universitario Nuestra Señora de Candelaria (Santa Cruz de Tenerife))
Madero, Lucía (Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas)
Arroyo, María Teresa (Hospital Clínico Universitario "Lozano Blesa" de Zaragoza)
Sicilia Aladrén, Beatriz (Hospital Universitario de Burgos)
Chaparro, María (Hospital Universitario de la Princesa (Madrid))
Martin-Arranz, María Dolores (Universidad Autónoma de Madrid)
Pajares, Ramón (Hospital Universitario Infanta Sofía (San Sebastián de los Reyes))
Mesonero, Francisco (Hospital Universitario Ramón y Cajal (Madrid))
Mañosa i Ciria, Míriam (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Martinez, Pilar (Hospital Universitario San Cecilio (Granada))
Chacón, Silvia (Hospital General Universitario Morales Meseguer (Múrcia))
Tosca, Joan (Hospital Clínic Universitari (València))
Marín, Sandra (Hospital Universitario Reina Sofía (Còrdova, Espanya))
Sanroman, Luciano (Hospital Álvaro Cunqueiro (Vigo))
Calvo, Marta (Hospital Universitario Puerta de Hierro Majadahonda (Madrid))
Monfort, David (Consorci Sanitari de Terrassa)
Saiz, Empar (Xarxa Assistencial University Hospital)
Zabana, Yamile (Hospital Universitari MútuaTerrassa)
Guerra, Iván (Hospital Universitario de Fuenlabrada ( Madrid))
Varela, Pilar (Hospital Universitario de Cabueñes (Gijón))
Baydal Bertomeu, Virginia (Hospital Universitari i Politècnic La Fe (València))
Faubel, Raquel (Hospital Universitari i Politècnic La Fe (València))
Corsino, Pilar (Hospital Universitario Miguel Servet (Saragossa))
Porto-Silva, Sol (Hospital Clínico Universitario (Santiago de Compostela, Galícia))
Brunet, Eduard (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
González, Melodi (Hospital Universitario Nuestra Señora de Candelaria (Santa Cruz de Tenerife))
Gutiérrez Casbas, Ana (Hospital Universitario Dr Balmis Alicante)
Nos, Pilar (Hospital Universitari i Politècnic La Fe (València))

Date:	2024
Abstract:	Background: Telemonitoring for inflammatory bowel disease (IBD) has not consistently demonstrated superiority over standard care; however, noninferiority may be an acceptable outcome if remote care proves to be more efficient. Objective: This study aims to compare the remission time and quality of life of patients with active IBD managed through standard care versus the TECCU (Telemonitoring of Crohn Disease and Ulcerative Colitis) app. Methods: A 2-arm, randomized, multicenter trial with a noninferiority design was conducted across 24 hospitals in Spain. The study included adult patients with IBD who were starting immunosuppressive or biological therapy. Participants were randomized into 2 groups: the telemonitoring group (G_TECCU) and the standard care group (G_Control). The follow-up schedule for the telemonitoring group (G_TECCU) was based on contacts via the TECCU app, while the control group (G_Control) adhered to standard clinical practice, which included in-person visits and telephone calls. In both groups, treatment adjustments were made based on the progression of disease activity and medication adherence, assessed using specific indices and biological markers at each check-up. The primary outcome was the duration of remission after 12 weeks, while secondary outcomes included quality of life, medication adherence, adverse events, and patient satisfaction. Results: Of the 169 patients enrolled, 158 were randomized and 150 were analyzed per protocol: telemonitoring (n=71) and control (n=79). After 12 weeks, the time in clinical remission was not inferior in the telemonitoring group (mean 4. 20, SD 3. 73 weeks) compared with the control group (mean 4. 32, SD 3. 28 weeks), with a mean difference between arms of -0. 12 weeks (95% CI -1. 25 to 1. 01; noninferiority P=. 02). The mean reduction in C-reactive protein values was -15. 40 mg/L (SD 90. 15 mg/L; P=. 19) in the G_TECCU group and -13. 16 mg/L (SD 54. 61 mg/L; P=. 05) in the G_Control group, with no significant differences between the 2 arms (P=. 73). Similarly, the mean improvement in fecal calprotectin levels was 832. 3 mg/L (SD 1825. 0 mg/L; P=. 003) in the G_TECCU group and 1073. 5 mg/L (SD 3105. 7 mg/L; P=. 03) in the G_Control group; however, the differences were not statistically significant (P=. 96). Quality of life improved in both groups, with a mean increase in the 9-item Inflammatory Bowel Disease Questionnaire score of 13. 44 points (SD 19. 1 points; P<. 001) in the G_TECCU group and 18. 23 points (SD 22. 9 points; P=. 001) in the G_Control group. Additionally, the proportion of patients who adhered to their medication significantly increased from 35% (25/71) to 68% (48/71) in the G_TECCU group (P=. 001) and from 46% (36/79) to 73% (58/79) in the G_Control group (P=. 001). The satisfaction rate remained stable at around 90%, although noninferiority was not demonstrated for the secondary outcomes. Conclusions: Telemonitoring patients with active IBD is not inferior to standard care for achieving and maintaining short-term remission. The TECCU app may serve as a viable alternative follow-up tool, pending confirmation of improved health outcomes and cost-effectiveness over the long-term.
Grants:	Instituto de Salud Carlos III PI18/00593
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Clinical trial ; Telemonitoring ; Inflammatory bowel disease ; Crohn disease ; Ulcerative colitis ; Quality of life ; Socioeconomical and psychological end points ; Health outcomes ; Remission time
Published in:	Journal of medical Internet research, Vol. 26 (November 2024) , ISSN 1438-8871

DOI: 10.2196/60966
PMID: 39189160

20 p, 803.1 KB

The record appears in these collections:
Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Parc Taulí Research and Innovation Institute (I3PT
Articles > Research articles
Articles > Published articles