TELE-monitoring in Chronic Obstructive Pulmonary Disease (TELECOPD)

July 19, 2018 updated by: Conde, Bebiana, M.D.

COPD is the fourth cause of death worldwide and it is expected to be the third in 2020.

Non-invasive ventilation (NIV) has a positive impact in reducing mortality related to chronic respiratory failure in stable patients with COPD. Moreover, the addition of home NIV to home oxygen therapy reduces hospital admissions and improves patients outcomes.

Patients monitoring is crucial. It is increasingly recognized the potential of telemedicine in reducing morbidity and mortality, as well as healthcare utilisation and its associated costs. In particular, home telemonitoring (TM)- a technology measuring patients'clinical parameters and symptoms at home and allowing communication between healthcare professionals and patients over distance- has gained much attention. However, despite a growing body of evidence for TM in the management of COPD and other chronic diseases, the benefit of telemonitoring for Home mechanical ventilation concerning clinical and economic outcomes remains to be clearly demonstrated.

The study aims to assess the impact that telemonitoring would have NIV efficacy, patient quality of life and satisfaction, through a prospective randomized study.The primary endpoint is the time for appropriate adaptation and therapy efficacy, defined as average SatO2 to 90% in 24h oximetry.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A prospective randomized study, with 2 branches.

The primary endpoint is the time for appropriate adaptation and therapy efficacy, defined as average SatO2 to 90% in 24h oximetry.

Patients with COPD (n=100) based in Gold 2017. Patients with stable COPD and Pa CO2 > 52 mmHg in blood gases. These patients might have a polygraph or polysomnographic sleep study AHI/RDI < 15/h

  1. 1st hospital visit - D0- Inclusion criteria Confirmation; Randomization to 2 groups (1 - telemonitoring group (TM group) with the equipment Lumis 150, Stellar 150 or ventilator Astral 150 with AirView system; 2 - conventional monitoring group (CM group); Mode and settings titration will be selected according to patients needs and tolerance; Education and adaptation of the patient to VNI and optimize ventilation.
  2. 2nd home healthcare professionals visit (D 1M)-
  3. 3th hospital visit- D 3M- Compliance and ventilation effectiveness assessment (24 oximetry and ventilator data analysis); Settings adjustment if required;
  4. 4th hospital visit - D 6M- Compliance and ventilation effectiveness assessment (24 oximetry and ventilator data analysis) ; Settings adjustment if required
  5. 5th hospital visit - D 12M- Compliance and ventilation effectiveness assessment (24 oximetry and ventilator data analysis); Settings adjustment if required

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Bebiana Conde, MD
  • Phone Number: 5291 00351259300500

Study Locations

  • Portugal
      • Vila Real, Portugal, 5000
        • Centro Hospitalar Tras-os-Montes e Alto Douro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with COPD (n=100) based in Gold 2017. Patients with Stable COPD and PaCO2 > 52 mmHg in blood gases. These patients might have a polygraph or polysomnographic sleep study AHI/RDI <15/h

Exclusion Criteria:

  • Patients with ventilatory treatment;
  • Without diagnosis of COPD
  • Polygraph or polysomnographic sleep study AHI/RDI >=15/h

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Telemonitoring in NonInvasiveVentilation

Tele-monitoring in noninvasive ventilation with Lumis 150 and others Resmed equipments with AirView monitoring system, in COPD patients.

• Education and adaptation of the patient to NIV.
Procedure: Telemonitoring in noninvasive ventilation
Compare telemonitoring to conventional monitoring to optimize Ventilation
No Intervention: 2- conventional monitoring group

Conventional monitoring group

• Education and adaptation of the patient to NIV.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time for appropriate adaptation and therapy efficacy
Time Frame: one year
Calculate the time required to achieve a 4-hour-day adherence on 70% of the days and a sato2 <90% in less than 10% of the time in 24-hour oximetry.
one year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of readmissions for COPD acute exacerbations and mortality
Time Frame: One year
Calculate the hospital readmission rate by COPD acute exacerbations and mortality for 1 year and compare these rates between the 2 intervention groups (conventional monitoring and telemonitoring)
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Conde, Bebiana, M.D.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ResMed

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bebiana Conde, MD, Centro Hospitalar Tras-os-Montes e Alto Douro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1 (Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Clinical data of the patients are required to adjust the ventilation parameters.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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