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Chaparro, MariaAuthorMartin-Arranz, Maria DoloresAuthor

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Telemonitoring of Active Inflammatory Bowel Disease Using theApp TECCU:Short-Term Results of a Multicenter Trial of GETECCU

Publicated to:Journal Of Medical Internet Research. 26 e60966- - 2024-11-18 26(), DOI: 10.2196/60966

Authors: Aguas, Mariam; Del Hoyo, Javier; Vicente, Raquel; Barreiro-de Acosta, Manuel; Melcarne, Luigi; Hernandez-Camba, Alejandro; Madero, Lucia; Arroyo, Maria Teresa; Sicilia, Beatriz; Chaparro, Maria; Martin-Arranz, Maria Dolores; Pajares, Ramon; Mesonero, Francisco; Manosa, Miriam; Martinez, Pilar; Chacon, Silvia; Tosca, Joan; Marin, Sandra; Sanroman, Luciano; Calvo, Marta; Monfort, David; Saiz, Empar; Zabana, Yamile; Guerra, Ivan; Varela, Pilar; Baydal, Virginia; Faubel, Raquel; Corsino, Pilar; Porto-Silva, Sol; Brunet, Eduard; Gonzalez, Melodi; Gutierrez, Ana; Nos, Pilar

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Abstract

Background: Telemonitoring for inflammatory bowel disease (IBD) has not consistently demonstrated superiority over standardcare; 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 throughstandard 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. Thestudy included adult patients with IBD who were starting immunosuppressive or biological therapy. Participants were randomizedinto 2 groups: the telemonitoring group (G_TECCU) and the standard care group (G_Control). The follow-up schedule for thetelemonitoring group (G_TECCU) was based on contacts via the TECCU app, while the control group (G_Control) adhered tostandard clinical practice, which included in-person visits and telephone calls. In both groups, treatment adjustments were madebased on the progression of disease activity and medication adherence, assessed using specific indices and biological markers ateach check-up. The primary outcome was the duration of remission after 12 weeks, while secondary outcomes included qualityof 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) andcontrol (n=79). After 12 weeks, the time in clinical remission was not inferior in the telemonitoring group (mean 4.20, SD 3.73weeks) 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 differencesbetween 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 differenceswere not statistically significant (P=.96). Quality of life improved in both groups, with a mean increase in the 9-item InflammatoryBowel Disease Questionnaire score of 13.44 points (SD 19.1 points; P

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