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

Chronic Obstructive Pulmonary Disease Clinical Trial

— HOV-C  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05815420
• Other study ID #: 2023-A00565-40
• Status: Not yet recruiting
• Start date: September 1, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: April 2023
• Source: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Non invasive ventilation
Treatment by non invasive ventilation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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