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

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

50

Phase

  • 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 Backup

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

Study Locations

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

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

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
Intervention / Treatment
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

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

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

Conde, Bebiana, M.D.

Collaborators

ResMed

Investigators

  • 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)

January 1, 2019

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

March 26, 2016

First Submitted That Met QC Criteria

April 25, 2017

First Posted (Actual)

April 26, 2017

Study Record Updates

Last Update Posted (Actual)

July 23, 2018

Last Update Submitted That Met QC Criteria

July 19, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1

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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