Oxygen Therapy Remote Monitoring in COPD Patients.

April 26, 2023 updated by: Vivisol

Observational Study: Oxygen Therapy Monitoring in COPD Patients Using Connected Devices.

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.

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • France
      • Aix-en-Provence, France
        • Recruiting
        • CHIAP
        • Contact:
          • Stéphanie Martinez, Dr
      • Antibes, France
        • Not yet recruiting
        • Cabinet privé
        • Contact:
          • Lionel Lerousseau, Dr
      • Avignon, France
        • Not yet recruiting
        • Cabinet libéral
        • Contact:
          • Florence Duperron, Dr
      • Avignon, France
        • Not yet recruiting
        • Ch Avignon
        • Contact:
          • Chérifa Gounane, Dr
      • Blois, France
        • Not yet recruiting
        • CH BLOIS
        • Contact:
          • Alexandre Bleinc, Dr
      • Briis-sous-Forges, France
        • Not yet recruiting
        • CH Bligny
        • Contact:
          • Darné Christian, Dr
      • Cannes, France
        • Not yet recruiting
        • Ch Cannes
        • Contact:
          • Fabien Rolland, Dr
      • Clamart, France, 92140
        • Not yet recruiting
        • Hôpital Percy
        • Contact:
          • Frédéric Rivière, Dr
      • Foix, France
        • Not yet recruiting
        • Cabinet libéral
        • Contact:
          • Isabelle Huet, Dr
      • Le Puy-en-Velay, France
        • Not yet recruiting
        • Cabinet libéral
        • Contact:
          • Ahmad Yousef, Dr
      • Libourne, France
        • Not yet recruiting
        • Ch Libourne
        • Contact:
          • Mathilde Monbrun, Dr
      • Lille, France, 59800
        • Not yet recruiting
        • Hôpital La Louvière
        • Contact:
          • François Jounieaux, Dr
      • Lyon, France
        • Not yet recruiting
        • Centre médical Parot
        • Contact:
          • Nelson Hanin, Dr
      • Marseille, France, 13384
        • Not yet recruiting
        • Hôpital d'Instruction des Armées Laveran
        • Contact:
          • Anaïs Briquet, Dr
      • Marseille, France, 13285
        • Not yet recruiting
        • Hôpital Saint Joseph
        • Contact:
          • Alain Palot, Dr
      • Marseille, France
        • Not yet recruiting
        • AP-HM Hôpital Nord
        • Contact:
          • Benjamin Coiffard, Dr
      • Montfermeil, France
        • Not yet recruiting
        • GHI Le Raincy
        • Contact:
          • Jamal Kabbani, Dr
      • Nancy, France, 54511
        • Not yet recruiting
        • CHRU Nancy-Université de Lorraine
        • Contact:
          • Ari Chaouat, Pr
      • Ollioules, France
        • Not yet recruiting
        • Polyclinique des Fleurs
        • Contact:
          • Thibaut Capron, Dr
      • Perpignan, France, 66000
        • Not yet recruiting
        • CH de Perpignan
        • Contact:
          • Emilienne Verkaeren, Dr
      • Perpignan, France, 66000
        • Not yet recruiting
        • Pneumology practice
        • Contact:
          • Serge Verdier, Dr
      • Pessac, France, 33600
        • Not yet recruiting
        • CHU de Bordeaux
        • Contact:
          • Léo Grassion, Dr
      • Poissy, France
        • Not yet recruiting
        • Cabinet libéral
        • Contact:
          • Antoine Achkar, Dr
      • Sainte-Feyre, France
        • Not yet recruiting
        • MGEN
        • Contact:
          • Marc Clavel, Dr

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Cohort of COPD patients who initiate long-term oxygen therapy.

Description

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 of their 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 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 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
Assessment of compliance of long term oxygen therapy
Time Frame: 3.5 months
For each patient, the average daily duration of oxygen use (expressed as numbers of hours of oxygen use per day) will be measured on period of 14 consecutive days at different times after the initiation of oxygen therapy (weeks 6 to 8, and then weeks 12 to 14). The duration of oxygen use is measured using the TeleOx medical device placed in each oxygen source (fixed and portable sources).
3.5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of long term oxygen therapy on heart rate
Time Frame: Month 2, Month 3.5
For each patient, the average and maximum daily heart rate (expressed as beats/minute) will be measured on period of 14 consecutive days at different times after the initiation of oxygen therapy (weeks 6 to 8, and then weeks 12 to 14). The heart rate is measured by the connected watch all along the day.
Month 2, Month 3.5
Impact of long term oxygen therapy on oxygen saturation in the blood (SpO2)
Time Frame: Month 2, Month 3.5
For each patient, the average nightime and daytime SpO2 (expressed in %) will be calculated by period of 14 consecutive days at different times after the initiation of oxygen therapy (weeks 6 to 8, and then weeks 12 to 14). The SpO2 is measured by the connected watch (automatically at night and manually in day).
Month 2, Month 3.5
Impact of long term oxygen therapy on the respiratory rate
Time Frame: Month 2, Month 3.5
For each patient, the median, maximum, and 95th percentile daily respiratory rate (expressed in cycles/minute) will be measured on period of 14 consecutive days at different times after the initiation of oxygen therapy (weeks 6 to 8, and then weeks 12 to 14). The respiratory rate is measured using the TeleOx medical device placed in each oxygen source (fixed and portable sources).
Month 2, Month 3.5
Impact of long term oxygen therapy on the physical activity in terms of duration of effort
Time Frame: Month 2, Month 3.5
For each patient, the total duration of effort per day (expressed in hours) will be measured on period of 14 consecutive days at different times after the initiation of oxygen therapy (weeks 6 to 8, and then weeks 12 to 14). The total duration of effort is measured by the connected watch.
Month 2, Month 3.5
Impact of long term oxygen therapy on the physical activity in terms of duration of number of steps
Time Frame: Month 2, Month 3.5
For each patient, the total number of steps per day will be measured on period of 14 consecutive days at different times after the initiation of oxygen therapy (weeks 6 to 8, and then weeks 12 to 14). The number of steps is measured by the connected watch.
Month 2, Month 3.5
Impact of long term oxygen therapy on the health related quality of life of COPD patients
Time Frame: At oxygen therapy initiation (baseline), Month 2, Month 3.5

The quality of life will be assessed using the COPD-specific health related quality of life questionnaire named VQ11.

The questionnaire VQ11 comprises 11 items distributed across three components (functional: 3 items, psychological: 4 items, social: 4 items). The global score ranges from 11 to 55 points; higher scores mean a better quality of life.
At oxygen therapy initiation (baseline), Month 2, Month 3.5
Impact of long term oxygen therapy on the respiratory function
Time Frame: At inclusion, Month 6
The pulmonologist will assess the evolution of respiratory function according to good medical practice with the pulmonary functional tests. Based on the VEMS/CV value (expressed in %), the pulmonologist judges if the prescribed long term oxygen therapy is sufficient to normalize the respiratory function or if the treatment must be modified.
At inclusion, Month 6
Assessment of exacerbation
Time Frame: Month 6
The pulmonologist will assess the number of exacerbation that occured during the first 6-months of long term oxygen therapy.
Month 6

Collaborators and Investigators

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

Sponsor

Vivisol

Collaborators

Slb Pharma

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 27, 2023

Primary Completion (Anticipated)

January 27, 2025

Study Completion (Anticipated)

January 27, 2025

Study Registration Dates

First Submitted

July 18, 2022

First Submitted That Met QC Criteria

July 21, 2022

First Posted (Actual)

July 26, 2022

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • O2 Connect
  • IDRCB 2022-A00825-38 (Other Identifier: French National Health Agency)

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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