Colitis, Ulcerative, Crohn's Disease
Conditions
Keywords
Crohn's Disease, Colitis, Ulcerative, Telemedicine
Brief summary
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).
Detailed description
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.
Interventions
DEVICETelemedicine
Monitoring and control is performed through telematics platform integrated management of chronic NOMHAD, configurated to respond the patients specific needs.
DEVICETelephone
A telephone control of their state and evolution will be made through the nursing staff of the unit.
OTHERConventional care
Conventional care provided in the unit to patients with IBD -high moderate complexity.
Sponsors
Instituto de Investigacion Sanitaria La Fe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged ≥18 years. * Inflammatory Bowel Disease at least 6 months duration, diagnosed according to the classical criteria of Lennard-Jones * Patients with Crohn's Disease or Ulcerative Colitis with moderate or severe activity (as Harvey-Bradshaw index and May, respectively) attending IBD unit during the period of inclusion. * Patients who initiate medical treatment with immunosuppressive drugs or biological agents, or are undergoing surgical treatment (surgery is considered as a treatment for EC). * Patient consents to participate in the study and sign and date personally indicating that it has been informed of all pertinent aspects of the study. * Patient not incur the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Remission | 6 months | Clinical remission of patients at 6 months of follow-up using Harvey-Bradshaw index for Crohn's disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 6 months | Measured by a satisfaction questionaire designed for the study. |
| Therapeutic adherence | 6 months | Measured by the validated Morisky-Green questionaire. |
| Urgent and scheduled visits and urgent hospital admissions | 6 months | Urgent and scheduled visits and urgent hospital admissions in the follow-up period will be captured directly systems hospital information (HIS). |
| Health-Related Quality of Life | 6 months | Health-Related Quality of Life measured by the generic Euroqol (EQ-5D) questionaire |
| Work activity and productivity (Cronh patients) | 6 months | Worrk activity and productivity measured by a validate questionaire: Vergara M. et al. Value Health 2011;14(6):859-61). |
| Mortality | 6 months | — |
| Directs health costs | 6 months | — |
| Number of surgical interventions related with the pathology | 6 months | — |
Outcome results
None listed