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

July 18, 2023 updated by: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

COPD Patient with a first prescription of NIV treatment

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of unplanned all-cause hospitalisations in routine clinical care in patients treated with NIV therapy who are continuously monitored by telemetric data
Time Frame: 1 year
Rate of unplanned all-cause hospitalisations in the study population normalised to one year of follow up
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

April 4, 2023

First Submitted That Met QC Criteria

April 4, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-A00565-40

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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