@Article{info:doi/10.2196/11602,
author="Del Hoyo, Javier
and Nos, Pilar
and Faubel, Raquel
and Mu{\~{n}}oz, Diana
and Dom{\'i}nguez, David
and Bastida, Guillermo
and Valdivieso, Bernardo
and Correcher, Marisa
and Aguas, Mariam",
title="A Web-Based Telemanagement System for Improving Disease Activity and Quality of Life in Patients With Complex Inflammatory Bowel Disease: Pilot Randomized Controlled Trial",
journal="J Med Internet Res",
year="2018",
month="Nov",
day="27",
volume="20",
number="11",
pages="e11602",
keywords="Crohn disease; e-health; inflammatory bowel disease; information and communication technology; telemedicine; ulcerative colitis",
abstract="Background: The reported efficacy of telemedicine in patients with inflammatory bowel disease (IBD) is inconsistent among studies, and data for complex IBD are lacking. Objective: We aimed to evaluate the impact of remote monitoring using a Web system---Telemonitorizaci{\'o}n de la Enfermedad de Crohn y Colitis Ulcerosa or Telemonitoring of Crohn's Disease and Ulcerative Colitis (TECCU)---as compared to standard care and telephone care on health outcomes and health care in patients with complex IBD. Methods: We performed a 3-arm randomized controlled trial. Adult patients with IBD who received immunosuppressants and biological agents were recruited from the IBD Unit of a tertiary university hospital. The patients were randomized into groups to receive remote monitoring (G{\_}TECCU), nurse-assisted telephone care (G{\_}NT), or standard care with in-person visits (G{\_}control). All patients completed the study visits at baseline and at 12 and 24 weeks in addition to each type of intervention. The primary outcome was the percentage of patients in remission at 24 weeks. Secondary health outcomes were quality of life, medication adherence, adverse effects, satisfaction, and social activities. Data on the number of outpatient visits and telephone calls, emergency visits, hospitalizations, IBD-related surgeries, and corticosteroid courses were also collected. Results: A total of 63 patients were selected (21 patients in each group). During the study, 90.5{\%} (19/21) of patients in G{\_}control, 95.2{\%} (20/21) in G{\_}NT, and 85.7{\%} (18/21) in G{\_}TECCU were compliant to the intervention. After 24 weeks, the percentage of patients in remission was higher in G{\_}TECCU (17/21, 81{\%}) than in G{\_}NT (14/21, 66.7{\%}) and G{\_}control (15/21, 71.4{\%}). A higher improvement in disease activity was observed in G{\_}TECCU than in G{\_}control in terms of the Harvey-Bradshaw/Mayo (odds ratio=0.12, 95{\%} CI=0.003-2.162, P=.19) and Harvey-Bradshaw/Walmsley (odds ratio=0.11, 95{\%} CI=0.004-1.55, P=.13) indexes. Improvement in disease activity was associated with a larger reduction in fecal calprotectin values in G{\_}TECCU compared to G{\_}control (estimated intervention effect: odds ratio=--0.90; 95{\%} CI=--1.96 to 0.16, P=.11). All completers adhered to treatment in G{\_}TECCU. In addition, the quality of life, social activities, and satisfaction improved in all 3 groups. Although the number of outpatient visits and telephone calls was lower in G{\_}TECCU than in G{\_}NT and G{\_}control, the safety profile was similar in all 3 groups. Conclusions: This pilot clinical trial suggests that the TECCU Web-based system is a safe strategy for improving health outcomes in patients with complex IBD and reducing the use of health care resources. Trial Registration: ClinicalTrials.gov NCT02943538; https://clinicaltrials.gov/ct2/show/NCT02943538 (Archived by WebCite at http://www.webcitation.org/746CRRtDN). ",
issn="1438-8871",
doi="10.2196/11602",
url="http://www.jmir.org/2018/11/e11602/",
url="https://doi.org/10.2196/11602",
url="http://www.ncbi.nlm.nih.gov/pubmed/30482739"
}