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Randomized Controlled Trial
. 2018 Nov 27;20(11):e11602.
doi: 10.2196/11602.

A Web-Based Telemanagement System for Improving Disease Activity and Quality of Life in Patients With Complex Inflammatory Bowel Disease: Pilot Randomized Controlled Trial

Javier Del Hoyo #  1 , Pilar Nos  1   2   3 , Raquel Faubel  4   5 , Diana Muñoz  1 , David Domínguez  6 , Guillermo Bastida  1   2   3 , Bernardo Valdivieso  5   7   8 , Marisa Correcher  9 , Mariam Aguas #  1   2   3
Affiliations
Randomized Controlled Trial

A Web-Based Telemanagement System for Improving Disease Activity and Quality of Life in Patients With Complex Inflammatory Bowel Disease: Pilot Randomized Controlled Trial

Javier Del Hoyo et al. J Med Internet Res. .

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-Telemonitorización 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).

Keywords: Crohn disease; e-health; inflammatory bowel disease; information and communication technology; telemedicine; ulcerative colitis.

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Conflict of interest statement

Conflicts of Interest: DD is the general manager of Connected Health Services.

Figures

Figure 1
Figure 1
Homepage of the NOMHADhome platform for access to questionnaires (patient version).
Figure 2
Figure 2
Home page of the NOMHADmobile platform for access to vital signs (patient version).
Figure 3
Figure 3
Flowchart of study participants. G_CONTROL: group receiving standard care with in-person visits; G_NT: group receiving nurse-assisted telephone care; G_TECCU: group receiving remote monitoring; IBD: inflammatory bowel disease.
Figure 4
Figure 4
Evolution of disease activity over the study period in the 3 groups. G_CONTROL: group receiving standard care with in-person visits; G_NT: group receiving nurse-assisted telephone care; G_TECCU: group receiving remote monitoring; HBI: Harvey-Bradshaw index.
Figure 5
Figure 5
Evolution of the median fecal calprotectin levels over the study period in the 3 groups. G_CONTROL: group receiving standard care with in-person visits; G_NT: group receiving nurse-assisted telephone care; G_TECCU: group receiving remote monitoring.
Figure 6
Figure 6
Evolution of the quality of life over the study period in the 3 groups. G_CONTROL: group receiving standard care with in-person visits; G_NT: group receiving nurse-assisted telephone care; G_TECCU: group receiving remote monitoring; IBDQ-9: Inflammatory Bowel Disease Questionnaire 9.
Figure 7
Figure 7
Evolution of the Morisky-Green score over the study period in the 3 groups. G_CONTROL: group receiving standard care with in-person visits; G_NT: group receiving nurse-assisted telephone care; G_TECCU: group receiving remote monitoring.
See this image and copyright information in PMC

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