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Aguas M, Del Hoyo J, Faubel R, et al. A Web-Based Telemanagement System for Patients With Complex Inflammatory Bowel Disease: Protocol for a Randomized Controlled Clinical Trial. JMIR Res Protoc. 2018;7(12):e190doi: 10.2196/resprot.9639.
Aguas, M., Del Hoyo, J., Faubel, R., Muñoz, D., Domínguez, D., Bastida, G., Navarro, B., Barrios, A., Valdivieso, B., Correcher, M., & Nos, P. (2018). A Web-Based Telemanagement System for Patients With Complex Inflammatory Bowel Disease: Protocol for a Randomized Controlled Clinical Trial. JMIR research protocols, 7(12), e190. https://doi.org/10.2196/resprot.9639
Aguas, Mariam, et al. "A Web-Based Telemanagement System for Patients With Complex Inflammatory Bowel Disease: Protocol for a Randomized Controlled Clinical Trial." JMIR research protocols vol. 7,12 (2018): e190. doi: https://doi.org/10.2196/resprot.9639
Aguas M, Del Hoyo J, Faubel R, Muñoz D, Domínguez D, Bastida G, Navarro B, Barrios A, Valdivieso B, Correcher M, Nos P. A Web-Based Telemanagement System for Patients With Complex Inflammatory Bowel Disease: Protocol for a Randomized Controlled Clinical Trial. JMIR Res Protoc. 2018 Dec 21;7(12):e190. doi: 10.2196/resprot.9639. PMID: 30578197; PMCID: PMC6320427.
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JMIR Res Protoc. 2018 Dec 21;7(12):e190. doi: 10.2196/resprot.9639.

A Web-Based Telemanagement System for Patients With Complex Inflammatory Bowel Disease: Protocol for a Randomized Controlled Clinical Trial.

JMIR research protocols

Mariam Aguas, Javier Del Hoyo, Raquel Faubel, Diana Muñoz, David Domínguez, Guillermo Bastida, Belén Navarro, Alejandra Barrios, Bernardo Valdivieso, Marisa Correcher, Pilar Nos

Affiliations

  1. Gastroenterology Department, La Fe University and Polytechnic Hospital, Valencia, Spain.
  2. CIBEREHD (Networked Biomedical Research Center for Hepatic and Digestive Diseases), Valencia, Spain.
  3. Health Research Institute La Fe, Valencia, Spain.
  4. Physiotherapy Department, University of Valencia, Valencia, Spain.
  5. Joint Research Unit in Biomedical Engineering (eRPSS: IIS La Fe-UPV), Valencia, Spain.
  6. Connected Health Services, Valencia, Spain.
  7. Home Care and Telemedicine Department, La Fe University and Polytechnic Hospital, Valencia, Spain.
  8. Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Madrid, Spain.
  9. Systems Department, La Fe University and Polytechnic Hospital, Valencia, Spain.

PMID: 30578197 PMCID: PMC6320427 DOI: 10.2196/resprot.9639

Abstract

BACKGROUND: Telemedicine has been successfully used to provide inflammatory bowel disease (IBD) patients with health care services remotely via the implementation of information and communications technology, which uses safe and feasible apps that have been well accepted by patients in remission. However, the design of telemedicine apps in this setting involves difficulties that hinder the adherence of patients to the follow-up plans and the efficacy of these systems to improve disease activity and quality of life.

OBJECTIVE: This study aimed to evaluate the development of a Web platform, Telemonitoring of Crohn Disease and Ulcerative Colitis (TECCU), for remote monitoring of patients with complex IBD and the design of a clinical trial involving IBD patients who received standard care (G_Control), nurse-assisted telephone care (G_NT), or care based on distance monitoring (G_TECCU).

METHODS: We describe the development of a remote monitoring system and the difficulties encountered in designing the platform. A 3-arm randomized controlled trial was designed to evaluate the effectiveness of this Web platform in disease management compared with G_NT and G_Control.

RESULTS: According to the schedules established for the medical treatment initiated (corticosteroids, immunosuppressants, or biological agents), a total of 63 patients (21 patients from each group) answered periodic questionnaires regarding disease activity, quality of life, therapeutic adherence, adverse effects, satisfaction, work productivity, and social activities. Blood and stool analyses (fecal calprotectin) were performed periodically. On the basis of the results of these tests in G_TECCU, alerts were generated in a Web platform with adapted action plans, including changes in medication and frequency of follow-up. The main issues found were the development of an easy-to-use Web platform, the selection of validated clinical scores and objective biomarkers for remote monitoring, and the design of a clinical trial to compare the 3 main follow-up methods evaluated to date in IBD.

CONCLUSIONS: The development of a Web-based remote management program for safe and adequate control of IBD proved challenging. The results of this clinical trial will advance knowledge regarding the effectiveness of TECCU Web platform for improvement of disease activity, quality of life, and use of health care resources in complex IBD patients.

TRIAL REGISTRATION: ClinicalTrials.gov NCT02943538; https://clinicaltrials.gov/ct2/show/NCT02943538 (Archived by WebCite at http://www.webcitation.org/6y4DQdmt8).

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/9639.

©Mariam Aguas, Javier del Hoyo, Raquel Faubel, Diana Muñoz, David Domínguez, Guillermo Bastida, Belén Navarro, Alejandra Barrios, Bernardo Valdivieso, Marisa Correcher, Pilar Nos. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 21.12.2018.

Keywords: Crohn disease; eHealth; inflammatory bowel disease; information technology; telemedicine; ulcerative colitis

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