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

NCT05815420 | Unknown

• 1 other identifier: 2023-A00565-40
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Non invasive ventilation; Telemonitoring

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Non invasive ventilation DEVICE

Treatment by non invasive ventilation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD Patient with a first prescription of NIV treatment

You may qualify if:

• 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.

You may not qualify if:

• Invasive ventilation therapy
• Another life-threatening disease with estimated survival \< 12 months (other than COPD, e.g. cancer)

Sponsors & Collaborators

• Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

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

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: April 18, 2023
• Study Start: September 1, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: July 20, 2023

Record last verified: 2023-04