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Randomized Controlled Trial
. 2024 Nov 18:26:e60966.
doi: 10.2196/60966.

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

Mariam Aguas #  1   2 , Javier Del Hoyo #  1   2 , Raquel Vicente  3 , Manuel Barreiro-de Acosta  4 , Luigi Melcarne  5 , Alejandro Hernandez-Camba  6 , Lucía Madero  7   8 , María Teresa Arroyo  9 , Beatriz Sicilia  10 , María Chaparro  8   11 , María Dolores Martin-Arranz  12   13 , Ramón Pajares  14 , Francisco Mesonero  15 , Miriam Mañosa  8   16 , Pilar Martinez  17 , Silvia Chacón  18 , Joan Tosca  19 , Sandra Marín  20 , Luciano Sanroman  21 , Marta Calvo  22 , David Monfort  23 , Empar Saiz  24 , Yamile Zabana  8   25 , Ivan Guerra  26 , Pilar Varela  27 , Virginia Baydal  1 , Raquel Faubel  28   29 , Pilar Corsino  3 , Sol Porto-Silva  4 , Eduard Brunet  5 , Melodi González  6 , Ana Gutiérrez  7 , Pilar Nos  1   2
Affiliations
Randomized Controlled Trial

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

Mariam Aguas et al. J Med Internet Res. .

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.

Trial registration: ClinicalTrials.gov NCT06031038; https://clinicaltrials.gov/ct2/show/NCT06031038.

International registered report identifier (irrid): RR2-10.2196/resprot.9639.

Keywords: Crohn disease; clinical trial; health outcomes; inflammatory bowel disease; quality of life; remission time; socioeconomical and psychological end points; telemonitoring; ulcerative colitis.

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Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
Geographical locations of the participating centers. TECCU: Telemonitorización de la Enfermedad de Crohn y Colitis Ulcerosa or Telemonitoring of Crohn’s Disease and Ulcerative Colitis.
Figure 2
Figure 2
Study flowchart. G_CONTROL is the group receiving standard care with in-person visits and telephone calls as usual practice; G_TECCU is the group receiving remote monitoring. IBD: inflammatory bowel disease; TECCU: Telemonitorización de la Enfermedad de Crohn y Colitis Ulcerosa or Telemonitoring of Crohn’s Disease and Ulcerative Colitis.
Figure 3
Figure 3
(A) Differences in the time in clinical remission between the 2 arms by the PP population. (B) Differences in the time in clinical remission between the 2 arms by the ITT population. (C) Differences in the time in clinical remission between the 2 arms by the PP population in multiplicity adjustments. (D) Differences in the time in clinical remission between the 2 arms by the ITT population in multiplicity adjustments. The data are shown for the whole cohort of patient analyzed and for specific subgroup (patients with UC or CD) analysis. Control: group of IBD patients receiving standard care with in-person visits; TECCU: group of IBD patients receiving remote monitoring. The dashed vertical line represents the non-inferiority margin of -1.5 weeks. CD: Crohn disease; ITT: intention to treat; PP: per-protocol; TECCU: Telemonitorización de la Enfermedad de Crohn y Colitis Ulcerosa or Telemonitoring of Crohn’s Disease and Ulcerative Colitis; UC: ulcerative colitis.
Figure 4
Figure 4
Evolution of the mean of (A) C-reactive protein and (B) fecal calprotectin levels over the study period in the 2 arms. Control: group receiving standard care with in-person visits; TECCU: group receiving remote monitoring. TECCU: Telemonitorización de la Enfermedad de Crohn y Colitis Ulcerosa or Telemonitoring of Crohn’s Disease and Ulcerative Colitis.
Figure 5
Figure 5
Evolution of the IBDQ-9 score over the study period in the 2 arms. Control: group receiving standard care with in-person visits; TECCU: group receiving remote monitoring. IBDQ-9: 9-item Inflammatory Bowel Disease Questionnaire; TECCU: Telemonitorización de la Enfermedad de Crohn y Colitis Ulcerosa or Telemonitoring of Crohn’s Disease and Ulcerative Colitis.
Figure 6
Figure 6
Evolution of the MMAS-8 score over the study period in the 2 arms. Control, group receiving standard care with in-person visits; TECCU, group receiving remote monitoring. MMAS-8: 8-item Morisky Medication Adherence Scale; TECCU: Telemonitorización de la Enfermedad de Crohn y Colitis Ulcerosa or Telemonitoring of Crohn’s Disease and Ulcerative Colitis.
Figure 7
Figure 7
Evolution of the patient satisfaction score over the study period in the 2 arms. Control: group receiving standard care with in-person visits; TECCU: group receiving remote monitoring. CSQ: Client Satisfaction Questionnaire; TECCU: Telemonitorización de la Enfermedad de Crohn y Colitis Ulcerosa or Telemonitoring of Crohn’s Disease and Ulcerative Colitis.
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