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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05815420
Other study ID # 2023-A00565-40
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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