Home Tele-Monitoring of Non-Invasive Ventilation in COPD Patients in France (HOV-C)

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

Status: Not yet enrolling

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Device: Non invasive ventilation

Study type: Observational

Funder types: Other

Identifiers

NCT05815420

2023-A00565-40

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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