Crohn's Disease Clinical Trial
Official title:
Clinical Impact of Telemedicine in Crohn's Disease and Ulcerative Colitis: Study Teccu
Pragmatic clinical trial, randomized, controlled parallel, 3 group (group technology platform, call group and control group), developed in the monograph Reference Unit of Inflammatory Bowel Disease Valencia (single-center).
Hypothesis: The interventions follow-up of patients with Crohn's Disease or Ulcerative
Colitis active moderate-high complexity based on the incorporation of information
technologies and communication, to improve monitoring of the presence of inflammatory
activity, adherence to treatment and drug toxicity, increase the proportion of inactive
patients (clinical remission) at 6 months follow-up and thus improve clinical outcomes and
health outcomes (HRQOL, satisfaction) and reduces the consumption of health resources.
Goals:
- Primary: To assess the effectiveness of intervention Teccu to achieve clinical
remission of IBD patients with moderate-high compared to usual care to these patients
(G_control) and assisted call with nurses (G_AT) complexity.
- Secondary: - To evaluate the effectiveness of interventions to improve HRQOL and
satisfaction with treatment in patients GTECCU intervention group compared to G_control
and G_AT in the 6 months follow up. - To assess the safety of the intervention Teccu
judging by adverse events that require a doctor's visit or unscheduled nursing. -
Describe the use of health resources (surgeries, hospitalizations, emergency room
visits and outpatient visits) by patients of G-Teccu, G_control and G_AT in the 6
months follow up. - Evaluate the effectiveness of intervention in the reduction of a
combined endpoint of hospital emergency room visits and unscheduled patients in the
intervention group compared to G-Teccu G_control and G_AT within 6 months of follow-up
consultations.
Description:
The proposed intervention is based on the extent of chronic GeCronic program that is
currently being developed at the Hospital La Fe de Valencia for comprehensive management of
chronic conditions of high complexity using the technology platform NOMHAD. NOMHADchronic is
a system designed to allow management services to deploy chronically ill supported by
technology. The product consists of different modules that seek to cover all aspects of that
management: clinical information on the status of patients according to their respective
conditions, support for the coordination of the actors during the care process, logistics
management and human resources, integration with accessories and monitoring devices. Of all
the modules of the platform, NOMHADcore out as the module which houses all the functionality
on clinical and care management of patients. There follows a detailed description of the
module, its structure and operation.
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