Compliance of Long-term Home Non-invasive Ventilation for Patients With Chronic Obstructive Pulmonary Disease

NCT04333901 | Completed

• 2 other identifiers: VENTIOBSIDRCB 2019 A01902-55
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 8

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

home non-invasive ventilation; compliance; quality of life; exacerbation

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (6)

• Evolution of the mean duration of NIV use per day

  month 1, month 6, month 12

• Impact of the home-NIV on the medical condition of COPD patients

  1 year

• Impact of the home-NIV on the dyspnea

  At inclusion, month 6, month 12

• Impact of the home-NIV on the respiratory function

  At inclusion, month 6, month 12

• Impact of the home-NIV on the health related quality of life of COPD patients

  At inclusion, month 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cohort of COPD patients who initiate long-term home-NIV.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vivisol: lead
• Slb Pharma: collaborator
• France Oxygène: collaborator
• MBar: collaborator

Study Sites (8)

Pays d'Aix hospital

Aix-en-Provence, 13616, France

Location

Cannes hospital

Cannes, 06414, France

Location

Henri-Mondor hospital (APHP)

Créteil, 94010, France

Location

Institut Médical de Sologne Les Pins

Lamotte-Beuvron, 41600, France

Location

Le Havre Jacques Monod hospital

Montivilliers, 76290, France

Location

Pitié Salpétrière hospital (APHP)

Paris, 75013, France

Location

Bichat hospital

Paris, 75877, France

Location

Saint-Nazaire hospital

Saint-Nazaire, 44600, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Patient Compliance

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Gilles Jébrak, MD

  Bichat Hospital, Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: April 3, 2020
• Study Start: December 16, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 15, 2023

Record last verified: 2023-03

Locations

FR (8)