Oxygen Therapy Remote Monitoring in COPD Patients.

Last updated: May 2, 2024
Sponsor: Vivisol
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05473780
O2 Connect
IDRCB 2022-A00825-38
  • Ages > 18
  • All Genders

Study Summary

Background : Long-term oxygen therapy is prescribed for patients with severe COPD. The aim of oxygen therapy is to administer oxygen at a concentration level higher than that of ambient air, in order to treat or prevent the symptoms and manifestations of arterial hypoxemia; this therapy can be applied either in an acute situation or as a long-term treatment, in cases of stabilized severe chronic hypoxemia.

Currently, pneumologists do not have the possibility, between 2 consultations spaced several months apart, to measure the patient's compliance with the treatment (adherence to oxygen therapy) nor the respect of the prescribed dosage (O2 flow and duration). In addition to the patient's adherence to the treatment, the specialist does not have the possibility to assess the patient's physical activity (walking ...).

This observational study is a e-health, prospective, multicenter study conducted in France under the control of pneumologists.

The main objective of this study is to evaluate the adherence to oxygen therapy in real life, and its evolution, in COPD patients justifying a long term oxygen therapy in stable state.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • COPD patients who require the initiation of a long term oxygen therapy.
  • Patient agreeing to use a connected watch and a TeleOx for the remote monitoring oftheir parameters and physical activity.
  • Non-smoker, ex-smoker, or patient agreeing to stop smoking.
  • Life expectancy greater than 6 months.
  • Signed informed consent form,
  • Subject affiliated to a health insurance system, or is a beneficiary.

Exclusion

Exclusion Criteria:

  • Patient initiated on oxygen therapy prior to the inclusion visit.
  • Patient with cognitive impairment.
  • Simultaneous participation in a health intervention research,
  • Vulnerable subjects.

Study Design

Total Participants: 250
Study Start date:
January 27, 2023
Estimated Completion Date:
January 27, 2025

Study Description

The observational study consists in collecting physiological data (cardiorespiratory and physical activity) and use of the oxygen therapy device in real life during the first months after the initiation of treatment.

For this purpose, two connected medical devices will be provided to each patient during 2 periods of 2 weeks (weeks 6 to 8 then weeks 12 to 14 after the initiation of oxygen therapy). The devices are: 1/ a connected watch that continuously measures vital parameters (heart rate and blood oxygen saturation), and physical activity parameters (no. of steps, distance, duration of effort), and 2/ a Teleox device that remotely monitors patients equipped with an oxygen source (it measures the oxygen flow rate requested by the patient, the duration of use of the oxygen source, and the breathing rate).

Study design: a cohort of 250 patients with COPD newly initiated a long term oxygen therapy will be enrolled in the study and follow-up over 6 months. Data will be collected by lung specialists and home health care provider teams at 2 months, 3.5 months and 6 months post-initiation of oxygen therapy.

Connect with a study center

  • CHIAP

    Aix-en-Provence,
    France

    Active - Recruiting

  • Cabinet privé

    Antibes,
    France

    Site Not Available

  • CH Avignon

    Avignon,
    France

    Site Not Available

  • Cabinet libéral

    Avignon,
    France

    Site Not Available

  • CH Blois

    Blois,
    France

    Site Not Available

  • CH Bligny

    Briis-sous-Forges,
    France

    Site Not Available

  • CH Cannes

    Cannes,
    France

    Site Not Available

  • Hôpital Percy

    Clamart, 92140
    France

    Site Not Available

  • Cabinet libéral

    Foix,
    France

    Site Not Available

  • Cabinet libéral

    Le Puy-en-Velay,
    France

    Site Not Available

  • CH Libourne

    Libourne,
    France

    Site Not Available

  • Hôpital La Louvière

    Lille, 59800
    France

    Site Not Available

  • Centre médical Parot

    Lyon,
    France

    Site Not Available

  • AP-HM Hopital nord

    Marseille,
    France

    Site Not Available

  • Hôpital Saint Joseph

    Marseille, 13285
    France

    Site Not Available

  • Hôpital d'Instruction des Armées Laveran

    Marseille, 13384
    France

    Site Not Available

  • GHI Le Raincy

    Montfermeil,
    France

    Site Not Available

  • CHRU Nancy-Université de Lorraine

    Nancy, 54511
    France

    Site Not Available

  • Polyclinique des fleurs

    Ollioules,
    France

    Site Not Available

  • CH de Perpignan

    Perpignan, 66000
    France

    Site Not Available

  • Pneumology practice

    Perpignan, 66000
    France

    Site Not Available

  • CHU de Bordeaux

    Pessac, 33600
    France

    Site Not Available

  • Cabinet libéral

    Poissy,
    France

    Site Not Available

  • MGEN

    Sainte-Feyre,
    France

    Site Not Available

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