Observance of Long Term Oxygen Therapy in Chronic Inspiratory Disease Patients (ObsO2)

September 22, 2020 updated by: SOS Oxygene Mediterranee
Long-term oxygen therapy (LTOT) is the reference treatment for chronic respiratory failure. This treatment is based on the principle of oxygen supplementation via a source to correct hypoxemia in patients. At present, adherence to this treatment is difficult to evaluate (reporting by patients), but the results of the literature show poor LTOT compliance. It is therefore important to accurately measure the oxygen consumption by patients and to understand the factors explaining LTOT compliance. The ultimate aim is to improve our patient management to make them more observant in order to improve the therapeutic efficacy of the treatment.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • CHU Arnaud de Villeneuve

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients are recruited from pneumologia unit of hospital and from private pneumologists

Description

Inclusion Criteria:

  • chronic respiratory disease patients with chronic hypoxemia
  • First prescribed long term oxygenotherapy

Exclusion Criteria:

  • patients with NIV and CPAP
  • vital pronostic < 3 months

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
oxygen use
Time Frame: 6 month
time of oxygen use
6 month

Secondary Outcome Measures

Outcome Measure
Time Frame
respiratory disease severity based on GOLD standards
Time Frame: baseline
baseline
quality of life assessed by a questionnaire (VQ-11)
Time Frame: baseline, 3 month and 6 month
baseline, 3 month and 6 month
precarity score assessed by a questionnaire (EPICE)
Time Frame: baseline
baseline

Collaborators and Investigators

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

Sponsor

SOS Oxygene Mediterranee

Collaborators

CHU Arnaud de Villeneuve MONTPELLIER

Investigators

  • Principal Investigator: Arnaud Bourdin, Professor, CHU Montpellier, France

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 (Actual)

January 1, 2017

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

June 12, 2017

First Submitted That Met QC Criteria

June 13, 2017

First Posted (Actual)

June 15, 2017

Study Record Updates

Last Update Posted (Actual)

September 23, 2020

Last Update Submitted That Met QC Criteria

September 22, 2020

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-A01244-47

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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