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

Fecha de publicación:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Vicente, R
  • Barreiro-de Acosta, M
  • Melcarne, L
  • Hernandez-Camba, A
  • Madero, L
  • Arroyo, MT
  • Sicilia, B
  • Chaparro, M
  • Martin-Arranz, MD
  • Pajares, R
  • Mesonero, F
  • Mañosa, M
  • Martinez, P
  • Chacón, S
  • Tosca, J
  • Marín, S
  • Sanroman, L
  • Calvo, M
  • Monfort, D
  • Saiz, E
  • Zabana, Y
  • Guerra, I
  • Varela, P
  • Baydal, V
  • Corsino, P
  • Porto-Silva, S
  • Brunet, E
  • González, M
  • Gutiérrez, A
  • GETECCU

Grupos

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<.001) in the G_TECCU group and 18.23 points (SD 22.9points; P=.001) in the G_Control group. Additionally, the proportion of patients who adhered to their medication significantlyincreased 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 theG_Control group (P=.001). The satisfaction rate remained stable at around 90%, although noninferiority was not demonstratedfor the secondary outcomes. Conclusions: Telemonitoring patients with active IBD is not inferior to standard care for achieving and maintaining short-termremission. The TECCU app may serve as a viable alternative follow-up tool, pending confirmation of improved health outcomesand cost-effectiveness over the long-term.Trial Registration: ClinicalTrials.gov NCT06031038; https://clinicaltrials.gov/ct2/show/NCT06031038 International Registered Report Identifier (IRRID): RR2-10.2196/resprot.9639(J Med Internet Res 2024;26:e60966) doi: 10.2196/60966

Datos de la publicación

ISSN/ISSNe:
1439-4456, 1438-8871

JOURNAL OF MEDICAL INTERNET RESEARCH  JMIR PUBLICATIONS, INC

Tipo:
Article
Páginas:
-
PubMed:
39189160
Factor de Impacto:
1,736 SCImago ℠
Cuartil:
Q1 SCImago ℠

Citas Recibidas en Web of Science: 5

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Keywords

  • clinical trial; telemonitoring; inflammatory bowel disease; Crohn disease; ulcerative colitis; quality of life; socioeconomical and psychological end points; health outcomes; remission tim

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