Chronic Obstructive Pulmonary DiseaseNCT04333901
Compliance of Long-term Home Non-invasive Ventilation for Patients With Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease, run by Vivisol at 8 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 25 participants
- Where
- 8 sitesFrance
- Study dates
- 16 Dec 2019to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cohort of COPD patients who initiate long-term home-NIV.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Pays d'Aix hospital
Aix-en-Provence, 13616
Cannes hospital
Cannes, 06414
Henri-Mondor hospital (APHP)
Créteil, 94010
Institut Médical de Sologne Les Pins
Lamotte-Beuvron, 41600
Le Havre Jacques Monod hospital
Montivilliers, 76290
Pitié Salpétrière hospital (APHP)
Paris, 75013
Bichat hospital
Paris, 75877
Saint-Nazaire hospital
Saint-Nazaire, 44600
About this study
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
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- home non-invasive ventilation, compliance, quality of life, exacerbation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Patient Compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the global compliance of the home-NIV over 1 year
For each patient, the total number of hours of NIV use divided by the number of days over the period of observation will be calculated.
Measured: 1 year
Secondary outcomes (6)
Evolution of the mean duration of NIV use per day
The mean number of hours of NIV use per day will be calculated by period of 30 consecutive days at different times over the year of home NIV introduction.
At each time, the proportion of patients with NIV use ≥ 4 hours per day will be calculated.
Measured: month 1, month 6, month 12
Impact of the home-NIV on the medical condition of COPD patients
The number of hospitalizations, COPD exacerbations, deaths will be monitored over 1 year.
Measured: 1 year
Impact of the home-NIV on the dyspnea
The respiratory function will be evaluated with the score of dyspnea assessed using the Modified Medical Research Council (mMRC) scale.
The score ranges from 0 to 4 points; higher scores mean a high dyspnea.
Measured: At inclusion, month 6, month 12
Impact of the home-NIV on the respiratory function
The pulmonologist will assess the evolution of respiratory function according to good medical practice with the pulmonary functional tests and blood gas analysis, and judge if the prescribed home-NIV treatment is sufficient to normalize the respiratory function or if the treatment must be modified.
Measured: At inclusion, month 6, month 12
Impact of the home-NIV on the health related quality of life of COPD patients
the quality of life will be assessed using the COPD-specific health related quality of life questionnaire named VQ11. The questionnaire VQ11 comprises 11 items distributed across three components (functional: 3 items, psychological: 4 items, social: 4 items). The global score ranges from 11 to 55 points; higher scores mean a better quality of life.
Measured: At inclusion, month 6
Assessment of home-NIV by patients
The home-NIV treatment will be assessed by patients using the S3-NIV questionnaire (this short questionnaire comprises 11 items distributed across three NIV-related components : respiratory Symptoms, Sleep quality and NIV-related Side effects. The global score varies between 0 to 10 points; higher scores mean a better outcome.
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start16 Dec 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivisol
- Sponsor type
- University, hospital or other
- Collaborators
- Slb Pharma, France Oxygène, MBar
- Responsible party
- Sponsor
- Investigators
- Gilles Jébrak, MD, Principal investigator, Bichat Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333901
- Sponsor's protocol ID
- VENTIOBS
- Other IDs
- IDRCB 2019 A01902-55
- Status last verified
- Mar 2023
- First submitted
- 4 Mar 2020
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04333901
- Acronym / sponsor ID
- VENTIOBS
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- home non-invasive ventilation, compliance, quality of life, exacerbation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- VivisolUniversity, hospital or other
- Collaborators
- Slb Pharma, France Oxygène, MBar
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 3 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort of COPD patients who initiate long-term home-NIV.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of the global compliance of the home-NIV over 1 year
Time frame: 1 year
For each patient, the total number of hours of NIV use divided by the number of days over the period of observation will be calculated.
6 secondary outcomes
Evolution of the mean duration of NIV use per day
Time frame: month 1, month 6, month 12
Impact of the home-NIV on the medical condition of COPD patients
Time frame: 1 year
Impact of the home-NIV on the dyspnea
Time frame: At inclusion, month 6, month 12
Impact of the home-NIV on the respiratory function
Time frame: At inclusion, month 6, month 12
Impact of the home-NIV on the health related quality of life of COPD patients
Time frame: At inclusion, month 6
Assessment of home-NIV by patients
Time frame: month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles Jébrak, MD principal investigator
Bichat Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Vivisol at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the global compliance of the home-NIV over 1 year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.