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

Sponsor
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05815420
Collaborator
(none)
40
Enrollment
32
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: Non invasive ventilation

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Home Tele-Monitoring of Non-Invasive Ventilation in Chronic Obstructive Pulmonary Disease in France
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Dec 30, 2024
Anticipated Study Completion Date :
Dec 30, 2025

Outcome Measures

Primary Outcome Measures

  1. Incidence of unplanned all-cause hospitalisations in routine clinical care in patients treated with NIV therapy who are continuously monitored by telemetric data [1 year]

    Rate of unplanned all-cause hospitalisations in the study population normalised to one year of follow up

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
ClinicalTrials.gov Identifier:
NCT05815420
Other Study ID Numbers:
  • 2023-A00565-40
First Posted:
Apr 18, 2023
Last Update Posted:
Apr 18, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Non invasive ventilation
Telemonitoring
Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Apr 18, 2023