Home Tele-Monitoring of Non-Invasive Ventilation in COPD Patients in France

Study Overview
=================
Brief Summary
-----------------
Tele-monitoring emerged and unfolded differently among various healthcare organisations and countries. Evidence regarding its impact on the management of COPD patients is still insufficient to draw firm conclusions. Assumption has been made that remote monitoring of home NIV treatment could help to identify novel predictors of the early detection of NIV failure and deteriorations in patients with COPD. The incidence in routine clinical care of unplanned all-cause and COPD-caused hospitalisations in patients treated with NIV therapy who are continuously monitored by telemetric data in France needs evaluation. In addition, predictors of unplanned all-cause and COPD-caused hospitalisations as well as of compliance and persistence to NIV therapy should be assessed in this patient population with special respect to continuous tele-monitoring. The study will determine in France the incidence in routine clinical care of unplanned all-cause and COPD-caused hospitalisations in patients treated with NIV therapy who are continuously monitored by telemetric data. Clinical and telemetric predictors of unplanned all-cause and COPD-caused hospitalisations and of NIV therapy compliance and persistence will be assessed in those patients

Official Title
-----------------
Home Tele-Monitoring of Non-Invasive Ventilation in Chronic Obstructive Pulmonary Disease in France

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Device: Non invasive ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age ≥18 years COPD eligible for NIV treatment Prescription of an adequate ResMed NIV device with tele-monitoring option as part of routine clinical care Acceptance of tele-monitoring and corresponding data handling Naive to long-term NIV treatment with initiation of NIV either ≤7 days before or after enrolment into study Able to fully understand information on data protection and provide written informed consent for use of corresponding medical and telemetric data. Exclusion criteria: Invasive ventilation therapy Another life-threatening disease with estimated survival < 12 months (other than COPD, e.g. cancer) Further exclusion criteria according to manua of the device intended and prescribed

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Non invasive ventilation|Treatment by non invasive ventilation|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of unplanned all-cause hospitalisations in routine clinical care in patients treated with NIV therapy who are continuously monitored by telemetric data | Rate of unplanned all-cause hospitalisations in the study population normalised to one year of follow up | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non invasive ventilation, Telemonitoring