NCT03188588

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 15, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

September 23, 2020

Status Verified

June 1, 2017

Enrollment Period

2 years

First QC Date

June 12, 2017

Last Update Submit

September 22, 2020

Conditions

Chronic Respiratory DiseaseHypoxemia

Outcome Measures

Primary Outcomes (1)

  • oxygen use

    time of oxygen use

    6 month

Secondary Outcomes (3)

  • respiratory disease severity based on GOLD standards

    baseline

  • quality of life assessed by a questionnaire (VQ-11)

    baseline, 3 month and 6 month

  • precarity score assessed by a questionnaire (EPICE)

    baseline

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Arnaud de Villeneuve

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Arnaud Bourdin, Professor

    CHU Montpellier, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2017

First Posted

June 15, 2017

Study Start

January 1, 2017

Primary Completion

January 1, 2019

Study Completion

January 1, 2020

Last Updated

September 23, 2020

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)