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TELE-monitoring in Chronic Obstructive Pulmonary Disease (TELECOPD)

Primary Purpose

COPD

Status
Unknown status
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Telemonitoring in noninvasive ventilation
Sponsored by
Conde, Bebiana, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring Non invasive ventilation in COPD, Noninvasive ventilation, Tele-monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro Hospitalar Tras-os-Montes e Alto Douro

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telemonitoring in NonInvasiveVentilation

2- conventional monitoring group

Arm Description

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.

Conventional monitoring group • Education and adaptation of the patient to NIV.

Outcomes

Primary Outcome Measures

Time for appropriate adaptation and therapy efficacy
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.

Secondary Outcome Measures

Rate of readmissions for COPD acute exacerbations and mortality
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)

Full Information

First Posted
March 26, 2016
Last Updated
July 19, 2018
Sponsor
Conde, Bebiana, M.D.
Collaborators
ResMed
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1. Study Identification

Unique Protocol Identification Number
NCT03129477
Brief Title
TELE-monitoring in Chronic Obstructive Pulmonary Disease
Acronym
TELECOPD
Official Title
TELE-monitoring in Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Anticipated)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Conde, Bebiana, M.D.
Collaborators
ResMed

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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 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. 2nd home healthcare professionals visit (D 1M)- 3th hospital visit- D 3M- Compliance and ventilation effectiveness assessment (24 oximetry and ventilator data analysis); Settings adjustment if required; 4th hospital visit - D 6M- Compliance and ventilation effectiveness assessment (24 oximetry and ventilator data analysis) ; Settings adjustment if required 5th hospital visit - D 12M- Compliance and ventilation effectiveness assessment (24 oximetry and ventilator data analysis); Settings adjustment if required

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
Non invasive ventilation in COPD, Noninvasive ventilation, Tele-monitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Masking Description
Computorizada randomizados selection
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telemonitoring in NonInvasiveVentilation
Arm Type
Experimental
Arm Description
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.
Arm Title
2- conventional monitoring group
Arm Type
No Intervention
Arm Description
Conventional monitoring group • Education and adaptation of the patient to NIV.
Intervention Type
Procedure
Intervention Name(s)
Telemonitoring in noninvasive ventilation
Intervention Description
Compare telemonitoring to conventional monitoring to optimize Ventilation
Primary Outcome Measure Information:
Title
Time for appropriate adaptation and therapy efficacy
Description
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Rate of readmissions for COPD acute exacerbations and mortality
Description
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)
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bebiana Conde, MD
Phone
00351936305294
Email
bebianaconde@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bebiana Conde, MD
Phone
00351259300500
Ext
5291
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bebiana Conde, MD
Organizational Affiliation
Centro Hospitalar Tras-os-Montes e Alto Douro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Hospitalar Tras-os-Montes e Alto Douro
City
Vila Real
ZIP/Postal Code
5000
Country
Portugal
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bebiana Conde, MD
Phone
00351936305294
Email
bebianaconde@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Clinical data of the patients are required to adjust the ventilation parameters.
Citations:
PubMed Identifier
25066329
Citation
Kohnlein T, Windisch W, Kohler D, Drabik A, Geiseler J, Hartl S, Karg O, Laier-Groeneveld G, Nava S, Schonhofer B, Schucher B, Wegscheider K, Criee CP, Welte T. Non-invasive positive pressure ventilation for the treatment of severe stable chronic obstructive pulmonary disease: a prospective, multicentre, randomised, controlled clinical trial. Lancet Respir Med. 2014 Sep;2(9):698-705. doi: 10.1016/S2213-2600(14)70153-5. Epub 2014 Jul 24.
Results Reference
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PubMed Identifier
24781217
Citation
Struik FM, Sprooten RT, Kerstjens HA, Bladder G, Zijnen M, Asin J, Cobben NA, Vonk JM, Wijkstra PJ. Nocturnal non-invasive ventilation in COPD patients with prolonged hypercapnia after ventilatory support for acute respiratory failure: a randomised, controlled, parallel-group study. Thorax. 2014 Sep;69(9):826-34. doi: 10.1136/thoraxjnl-2014-205126. Epub 2014 Apr 29.
Results Reference
background
PubMed Identifier
19213769
Citation
McEvoy RD, Pierce RJ, Hillman D, Esterman A, Ellis EE, Catcheside PG, O'Donoghue FJ, Barnes DJ, Grunstein RR; Australian trial of non-invasive Ventilation in Chronic Airflow Limitation (AVCAL) Study Group. Nocturnal non-invasive nasal ventilation in stable hypercapnic COPD: a randomised controlled trial. Thorax. 2009 Jul;64(7):561-6. doi: 10.1136/thx.2008.108274. Epub 2009 Feb 12.
Results Reference
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TELE-monitoring in Chronic Obstructive Pulmonary Disease

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