An interventional study of Telemedicine and Telephone in Crohn's Disease and Colitis, Ulcerative, sponsored by Instituto de Investigacion Sanitaria La Fe. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-18.
Sponsored by Instituto de Investigacion Sanitaria La Fe · Not applicable and Interventional
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:
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.
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 771 interventional studies indexed under Colitis.
Browse Colitis studies →Instituto de Investigacion Sanitaria La Fe is the lead sponsor of 57 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In this group, monitoring and control is performed through telematics platform integrated management of chronic NOMHAD, configurated to respond the patients specific needs.
Device: Telemedicine
A telephone control of their state and evolution will be made through the nursing staff of the unit.
Device: Telephone
Conventional care provided in the unit to patients with IBD -high moderate complexity.
Other: Conventional care
Monitoring and control is performed through telematics platform integrated management of chronic NOMHAD, configurated to respond the patients specific needs.
A telephone control of their state and evolution will be made through the nursing staff of the unit.
Conventional care provided in the unit to patients with IBD -high moderate complexity.
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
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
Work activity and productivity (Cronh patients)
Worrk activity and productivity measured by a validate questionaire: Vergara M. et al. Value Health 2011;14(6):859-61).
Time frame: 6 months
Mortality
Time frame: 6 months
Directs health costs
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Instituto de Investigacion Sanitaria La Fe