Telemedicine Crohn's Disease and Ulcerative Colitis (TECCU)

Instituto de Investigacion Sanitaria La Fe60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Crohn's Disease Colitis, Ulcerative

Interventions

TelemedicineDEVICE

Monitoring and control is performed through telematics platform integrated management of chronic NOMHAD, configurated to respond the patients specific needs.

TelephoneDEVICE

A telephone control of their state and evolution will be made through the nursing staff of the unit.

Conventional careOTHER

Conventional care provided in the unit to patients with IBD -high moderate complexity.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 exclusion criteria Exclusion Criteria: * Patients with cognitive or sensory impairments or with insufficient command of the two official languages of Valencia, in the opinion of the health professional conduct recruitment, hinder the understanding of the issues raised in the surveys, scales or instruments used in the study always who do not have a legal representative * Patients who are unable to handle a mobile phone to participate in the study. - Patients who do not have a phone line because, if they are assigned to G\_TECCU or G\_AT groups could not be implemented appropriate interventions. * They are participating at the time of recruitment in any other clinical trial or experimental study. Exclusion criteria will not be participating in observational studies * Terminals and / or palliative care according to the criteria of the SECPAL (Spanish Society of Palliative Care) Patients * Patients institutionalized * They are members of the research team, the staff of the research center or health centers involved in the study, or any other person directly involved in the study. * Relatives in the first degree of consanguinity or affinity of members of the research team, the staff of the research center or health centers involved in the study, or any other person directly involved in the study * Patients presenting as primary diagnosis mental illness * Patients with active cancer diagnosis * Patients in the assessment of professional performing recruitment not considered likely to be included for specific monitoring found in another unit such as hemodialysis, transplant unit, day hospital ... * Patients who do not agree to participate in the study or not to sign the corresponding informed consent

Outcomes

Primary Outcomes

Clinical Remission

Clinical remission of patients at 6 months of follow-up using Harvey-Bradshaw index for Crohn's disease.

Time frame: 6 months

Clinical Remission

Clinical remission of patients at 6 months of follow-up using May index for ulcerative colitis.

Time frame: 6 months

Secondary Outcomes

Health-Related Quality of Life

Health-Related Quality of Life measured by the generic Euroqol (EQ-5D) questionaire

Time frame: 6 months

Health-Related Quality of Life

Health-Related Quality of Life measured by the specific IBD in its reduced version (SIBDQ: Short Inflammatory Bowel Disease Questionnaire).

Time frame: 6 months

Patient Satisfaction

Measured by a satisfaction questionaire designed for the study.

Time frame: 6 months

Therapeutic adherence

Measured by the validated Morisky-Green questionaire.

Time frame: 6 months

Urgent and scheduled visits and urgent hospital admissions

Urgent and scheduled visits and urgent hospital admissions in the follow-up period will be captured directly systems hospital information (HIS).

Time frame: 6 months

Number of surgical interventions related with the pathology

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.