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

    Journal of medical Internet research（2024）

    Gastroenterology Department La Fe University and Polytechnic Hospital Valencia Spain | Miguel Servet University Hospital Zaragoza Spain | University Clinical Hospital Santiago Spain | Nuestra Señora de la Candelaria University Hospital Tenerife Spain | Dr Balmis General University Hospital ISABIAL Alicante Spain | Lozano Blesa Clinic University Hospital Zaragoza Spain | Burgos University Hospital Burgos Spain | CIBERehd Instituto de Salud Carlos III Madrid Spain | La Paz University Hospital Faculty of Medicine Universidad Autónoma de Madrid Madrid Spain | Infanta Sofía University Hospital Madrid Spain | Ramón y Cajal University Hospital Madrid Spain | San Cecilio Clinic University Hospital Parque Tecnológico de la Salud Granada Spain | Morales Meseguer General University Hospital Murcia Spain | Clinic University Hospital Valencia Spain | Reina Sofía University Hospital Córdoba Spain | Hospital Alvaro Cunqueiro Vigo Spain | Puerta de Hierro University Hospital Madrid Spain

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    Abstract
    BackgroundTelemonitoring 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. ObjectiveThis 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. MethodsA 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. ResultsOf 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. ConclusionsTelemonitoring 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. Trial RegistrationClinicalTrials.gov NCT06031038; https://clinicaltrials.gov/ct2/show/NCT06031038 International Registered Report Identifier (IRRID)RR2-10.2196/resprot.9639
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    Key words
    clinical trial,telemonitoring,inflammatory bowel disease,Crohn disease,ulcerative colitis,quality of life,socioeconomical and psychological end points,health outcomes,remission time
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    【要点】：本研究通过多中心随机试验评估了使用TECCU应用程序进行炎症性肠病(IBD)远程监测的效果，表明其在维持短期缓解方面不劣于标准护理，同时可能提高患者的生活质量和药物依从性。
    

    【方法】：采用两臂随机、多中心、非劣性设计的临床试验，在西班牙24家医院进行，将患者随机分为使用TECCU应用程序的远程监测组(G_TECCU)和接受标准护理的对照组(G_Control)。
    

    【实验】：共169名患者参与，158名被随机分组，最终150名患者按协议分析。经过12周，远程监测组和对照组的临床缓解时间无显著差异，两组的生活质量均有所提高，药物依从性显著增加，患者满意度保持在90%左右。实验使用的数据集未具体提及。