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

NCT ID: NCT05815420

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-12-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Non invasive ventilation

Treatment by non invasive ventilation

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2023-A00565-40

Identifier Type: -

Identifier Source: org_study_id