Clinical trial NCT04333901: Compliance of Long-term Home Non-invasive Ventilation for Patients With Chronic Obstructive Pulmonary Disease
Official title: Assessment of the Home Non-invasive Compliance in Patients With Chronic Obstructive Pulmonary Disease Following the Introduction of Long-term Ventilation. An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: home non-invasive ventilation
compliance
quality of life
exacerbation
Lead sponsor: Vivisol
Sponsor class: OTHER
Collaborators: name: Slb Pharma
name: France Oxygène
name: MBar
First posted: 2020-04-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort of COPD patients who initiate long-term home-NIV.

Brief summary: Background : Long-term home non-invasive ventilation (NIV) can be proposed as treatment for acute respiratory failure with severe alveolar hypoventilation. The aim of NIV is to correct both daytime and night-time hypoventilation and associated symptoms and to provide the patient with adequate night-time oxygen saturation. The benefits of long-term NIV in the management of chronic obstructive pulmonary disease (COPD) patients in a stable state remain controversial. This highlights the importance of identifying the predictive factors for good compliance to the NIV, defined as a use of more than 4 hours per day.

Aim of the study: The main objective is this observational study is to monitor the home NIV compliance over a period of 1 year under real conditions of treatment in patients with COPD newly initiated onto NIV (with telemonitoring or not) in order to specify the predictive criteria for good compliance. The secondary objectives are to assess the evolution of functional respiratory data, NIV parameters and changes in prescription, occurrence of acute exacerbations of COPD, hospitalizations and death, patient outcomes (quality of life and acceptability of NIV).

Study design: a cohort of 120 patients with COPD newly initiated onto home-NIV (with telemonitoring or not), either in a stable state or following an acute exacerbation will be enrolled in the study and follow-up over 1 year. Data will be collected by lung specialists and home health care provider teams at 1-month post-initiation of NIV, 6 months and 1 year. The study is conduct in France.


Eligibility criteria: Inclusion Criteria:

* COPD patients who require the initiation of a home-NIV (in case of previous equipment: NIV interrupted for more than 6 months).
* Life expectancy greater than 1 year.
* Patient who has agreed to participate in the observational study after receiving clear information from the investigator and signing the consent form.

Exclusion Criteria:

* NIV indicated for the treatment of chronic respiratory failure other than COPD.
* Patient with overlap syndrome (COPD associated to OSA).
* Patient with limitations who do not allow proper use of the NIV device.
* Simultaneous participation in a health intervention research.

Primary outcomes:
measure: Assessment of the global compliance of the home-NIV over 1 year
timeFrame: 1 year
Secondary outcomes:
measure: Evolution of the mean duration of NIV use per day
timeFrame: month 1, month 6, month 12
measure: Impact of the home-NIV on the medical condition of COPD patients
timeFrame: 1 year
measure: Impact of the home-NIV on the dyspnea
timeFrame: At inclusion, month 6, month 12
measure: Impact of the home-NIV on the respiratory function
timeFrame: At inclusion, month 6, month 12
measure: Impact of the home-NIV on the health related quality of life of COPD patients
timeFrame: At inclusion, month 6
measure: Assessment of home-NIV by patients
timeFrame: month 6
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Pays d'Aix hospital
city: Cannes
country: France
facility: Cannes hospital
city: Créteil
country: France
facility: Henri-Mondor hospital (APHP)
city: Lamotte-Beuvron
country: France
facility: Institut Médical de Sologne Les Pins
city: Montivilliers
country: France
facility: Le Havre Jacques Monod hospital
city: Paris
country: France
facility: Pitié Salpétrière hospital (APHP)
city: Paris
country: France
facility: Bichat hospital
city: Saint-Nazaire
country: France
facility: Saint-Nazaire hospital
Study officials:
affiliation: Bichat Hospital, Paris
name: Gilles Jébrak, MD
role: PRINCIPAL_INVESTIGATOR
References: