P205 A telemanagement system web in patients with complex inflammatory bowel disease: design and implementation of a randomized clinical trial
Aguas M.*1,2, Del Hoyo J.1, Muñoz D.1, Faubel R.3,4, Barrios A.1, Navarro B.1, Bastida G.1,2, Valdivieso B.5, Nos P.1,2
1La Fe University and Politechnic Hospital, Gastroenterology, Valencia, Spain 2CIBEREHD, Networked Biomedical Research Center for Hepatic and Digestive Diseases, Valencia, Spain 3Joint Research Unit in Biomedical Engineering - eRPSS (ICT applied to healthcare process re-engineering) IIS La Fe-UPV, Valencia, Spain 4Health Services Research on Chronic Patients Network (REDISSEC), Valencia, Spain 5La Fe University and Politechnic Hospital, Telemedicine Unit, Valencia, Spain
Inflammatory bowel disease (IBD) is a chronic and relapsing gastrointestinal disorder that requires continuous and personalized follow-up to achieve long remission and minimize short and long-term damage. Telemedicine has been successfully used to provide healthcare services remotely with the implementation of information and communication technologies in IBD patients. Aims: To develop a platform web, TECCU (Telemonitorizaciόn en Enfermedad de Crohn y Colitis Ulcerosa), for a remote control of complex IBD patients (moderate-severe activity) and compare disease activity over 24 weeks in a clinical trial of IBD patients who received standard care (Control_G) vs nursing care by telephone (NT_G) vs intervention based on distance monitoring TECCU_G). Secondarily, to assess health-related quality of life, adverse events, therapeutic adherence and the impact on direct health care costs.
We describe the development of a remote monitoring system and the difficulties encountered in the platform design. Moreover, a three-arm randomized controlled trial was designed to evaluate the effectiveness of this web platform in decreasing disease activity compared to NT_G and Control_G.
Inclusion criteria: IBD patients diagnosed according to internationally criteria; ≥be 18 years; CD or UC patients with moderate or severe activity attending in the IBD unit during the inclusion period; Patients starting medical treatment with corticosteroids, immunosuppressive or biological agents.
Patients from each group, according to schedules established in relation to the started treatment, answer periodic questionnaires regarding disease activity, quality of life, treatment adherence, side effects, satisfaction, work productivity and social activities. Blood and stool (fecal calprotectin) analysis is performed periodically. Based on the results of these tests in G_TECCU, alerts are generated in a platform web, with adapted action plans including changes in medication and following-up frequency. Similarly, in the telephone and usual care groups these interventions are developed by telephone and clinical visits, respectively.
The development of a remote management program of IBD patients via web (TECCU) can be a challenge for achieving adequate and safe control of the disease from a distance. The results of this clinical trial could show the efficacy of a web-based telemonitoring system to improve disease activity, quality of life and to decrease health care using in complex IBD patients.