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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.
- 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.
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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Telemedicine, Telephone, Conventional care
Active, not recruiting
Instituto de Investigacion Sanitaria La Fe
Published on BioPortfolio: 2016-10-26T05:53:22-0400
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Inflammatory Bowel Diseases (IBD) refers to a category of disorders, consisting of Crohn's Disease (CD) and Ulcerative Colitis (UC), where segments of the gastrointestinal tract become inf...
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A chronic transmural inflammation that may involve any part of the DIGESTIVE TRACT from MOUTH to ANUS, mostly found in the ILEUM, the CECUM, and the COLON. In Crohn disease, the inflammation, extending through the intestinal wall from the MUCOSA to the serosa, is characteristically asymmetric and segmental. Epithelioid GRANULOMAS may be seen in some patients.
A condition characterized by persistent or recurrent labial enlargement, ORAL ULCER, and other orofacial manifestations in the absence of identifiable CROHN DISEASE; or SARCOIDOSIS. There is no consensus on whether orofacial granulomatosis is a distinct clinical disorder or an initial presentation of Crohn disease.
Therapeutic practices which are not currently considered an integral part of conventional allopathic medical practice. They may lack biomedical explanations but as they become better researched some (PHYSICAL THERAPY MODALITIES; DIET; ACUPUNCTURE) become widely accepted whereas others (humors, radium therapy) quietly fade away, yet are important historical footnotes. Therapies are termed as Complementary when used in addition to conventional treatments and as Alternative when used instead of conventional treatment.
Organization of medical and nursing care according to the degree of illness and care requirements in the hospital. The elements are intensive care, intermediate care, self-care, long-term care, and organized home care.
Chronic, non-specific inflammation of the GASTROINTESTINAL TRACT. Etiology may be genetic or environmental. This term includes CROHN DISEASE and ULCERATIVE COLITIS.
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