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Crohn's DiseaseTECCUNCT02943538

Telemedicine Crohn's Disease and Ulcerative Colitis (TECCU)

A study testing Telemedicine, Telephone and Conventional care in people with Crohn's Disease and Colitis, Ulcerative, run by Instituto de Investigacion Sanitaria La Fe.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn's Disease, Colitis, Ulcerative
What is being tested?
Telemedicine, Telephone and Conventional care
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
May 2014to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
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  • 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

About this study

Official title: Clinical Impact of Telemedicine in Crohn's Disease and Ulcerative Colitis: Study Teccu

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).

Read the 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.

Being tested
Telemedicine, Telephone, Conventional care
Keywords
Crohn's Disease, Colitis, Ulcerative, Telemedicine
Medical subject headings
Crohn Disease, Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT02943538
Study groupRoleWhat they receive
Telemedicine groupExperimentalIn this group, monitoring and control is performed through telematics platform integrated management of chronic NOMHAD, configurated to respond the patients specific needs.
Receives: Device: Telemedicine
Telephone support groupExperimentalA telephone control of their state and evolution will be made through the nursing staff of the unit.
Receives: Device: Telephone
Control groupActive comparatorConventional care provided in the unit to patients with IBD -high moderate complexity.
Receives: Other: Conventional care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Remission

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

    Measured: 6 months

  2. Clinical Remission

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

    Measured: 6 months

Secondary outcomes (9)

  1. Health-Related Quality of Life

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

    Measured: 6 months

  2. 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).

    Measured: 6 months

  3. Patient Satisfaction

    Measured by a satisfaction questionaire designed for the study.

    Measured: 6 months

  4. Therapeutic adherence

    Measured by the validated Morisky-Green questionaire.

    Measured: 6 months

  5. 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).

    Measured: 6 months

  6. Number of surgical interventions related with the pathology

    Measured: 6 months

  7. 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).

    Measured: 6 months

  8. Mortality

    Measured: 6 months

  9. Directs health costs

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2016 (estimated)
  2. Study startMay 2014
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02943538
Sponsor's protocol ID
Study Teccu
Acronym
TECCU
Status last verified
Jan 2017
First submitted
20 Oct 2016
Last updated
18 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31538948

  • 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.

    PubMed 30578197

  • 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.

    PubMed 30482739

Questions about this trial

What is this clinical trial studying?

A study testing Telemedicine, Telephone and Conventional care in people with Crohn's Disease and Colitis, Ulcerative, run by Instituto de Investigacion Sanitaria La Fe.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Remission (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02943538, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2017.

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