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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemedicine group | Experimental | In this group, monitoring and control is performed through telematics platform integrated management of chronic NOMHAD, configurated to respond the patients specific needs. |
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| Telephone support group | Experimental | A telephone control of their state and evolution will be made through the nursing staff of the unit. |
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| Control group | Active Comparator | Conventional care provided in the unit to patients with IBD -high moderate complexity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine | Device | Monitoring and control is performed through telematics platform integrated management of chronic NOMHAD, configurated to respond the patients specific needs. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Remission | Clinical remission of patients at 6 months of follow-up using Harvey-Bradshaw index for Crohn's disease. | 6 months |
| Clinical Remission | Clinical remission of patients at 6 months of follow-up using May index for ulcerative colitis. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Health-Related Quality of Life | Health-Related Quality of Life measured by the generic Euroqol (EQ-5D) questionaire | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marian Aguas | Instituto de Investigación Sanitaria La Fe | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31538948 | Derived | Del Hoyo J, Nos P, Bastida G, Faubel R, Munoz D, Garrido-Marin A, Valero-Perez E, Bejar-Serrano S, Aguas M. Telemonitoring of Crohn's Disease and Ulcerative Colitis (TECCU): Cost-Effectiveness Analysis. J Med Internet Res. 2019 Sep 13;21(9):e15505. doi: 10.2196/15505. | |
| 30578197 | Derived | Aguas M, Del Hoyo J, Faubel R, Munoz D, Dominguez D, Bastida G, Navarro B, Barrios A, Valdivieso B, Correcher M, Nos P. A Web-Based Telemanagement System for Patients With Complex Inflammatory Bowel Disease: Protocol for a Randomized Controlled Clinical Trial. JMIR Res Protoc. 2018 Dec 21;7(12):e190. doi: 10.2196/resprot.9639. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 6, 2018 | |
| Reset | Apr 2, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 6, 2018 | Apr 2, 2018 |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Telephone | Device | A telephone control of their state and evolution will be made through the nursing staff of the unit. |
|
| Conventional care | Other | Conventional care provided in the unit to patients with IBD -high moderate complexity. |
|
| 6 months |
| Patient Satisfaction | Measured by a satisfaction questionaire designed for the study. | 6 months |
| Therapeutic adherence | Measured by the validated Morisky-Green questionaire. | 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). | 6 months |
| Number of surgical interventions related with the pathology | 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). | 6 months |
| Mortality | 6 months |
| Directs health costs | 6 months |
| 30482739 | Derived | Del Hoyo J, Nos P, Faubel R, Munoz D, Dominguez D, Bastida G, Valdivieso B, Correcher M, Aguas M. A Web-Based Telemanagement System for Improving Disease Activity and Quality of Life in Patients With Complex Inflammatory Bowel Disease: Pilot Randomized Controlled Trial. J Med Internet Res. 2018 Nov 27;20(11):e11602. doi: 10.2196/11602. |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |