Telemedicine Crohn's Disease and Ulcerative Colitis (TECCU)

NCT02943538 | Completed

• 1 other identifier: Study Teccu
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Crohn's Disease; Colitis, Ulcerative

Keywords

Crohn's Disease; Colitis, Ulcerative; Telemedicine

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (9)

• Health-Related Quality of Life

  6 months

• Health-Related Quality of Life

  6 months

• Patient Satisfaction

  6 months

• Therapeutic adherence

  6 months

• Urgent and scheduled visits and urgent hospital admissions

  6 months

Study Arms (3)

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.

Device: Telemedicine

Telephone support group

EXPERIMENTAL

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

Device: Telephone

Control group

ACTIVE COMPARATOR

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

Other: Conventional care

Interventions

Telemedicine DEVICE

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

Telemedicine group

Telephone DEVICE

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

Telephone support group

Conventional care OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥18 years.
• Inflammatory Bowel Disease at least 6 months duration, diagnosed according to the classical criteria of Lennard-Jones
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Instituto de Investigacion Sanitaria La Fe: lead

Related Publications (3)

• 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.

  PMID: 31538948 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.

  PMID: 30578197 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.

  PMID: 30482739 DERIVED

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Marian Aguas

  Instituto de Investigación Sanitaria La Fe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: October 24, 2016
• Study Start: May 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 18, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share