Clinical trial NCT05473780: Oxygen Therapy Remote Monitoring in COPD Patients.
Official title: Observational Study: Oxygen Therapy Monitoring in COPD Patients Using Connected Devices.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: long term oxygen therapy
compliance
quality of life
exacerbation
Lead sponsor: Vivisol
Sponsor class: OTHER
Collaborators: name: Slb Pharma
First posted: 2022-07-26
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort of COPD patients who initiate long-term oxygen therapy.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of compliance of long term oxygen therapy
timeFrame: 3.5 months
Secondary outcomes:
measure: Impact of long term oxygen therapy on heart rate
timeFrame: Month 2, Month 3.5
measure: Impact of long term oxygen therapy on oxygen saturation in the blood (SpO2)
timeFrame: Month 2, Month 3.5
measure: Impact of long term oxygen therapy on the respiratory rate
timeFrame: Month 2, Month 3.5
measure: Impact of long term oxygen therapy on the physical activity in terms of duration of effort
timeFrame: Month 2, Month 3.5
measure: Impact of long term oxygen therapy on the physical activity in terms of duration of number of steps
timeFrame: Month 2, Month 3.5
measure: Impact of long term oxygen therapy on the health related quality of life of COPD patients
timeFrame: At oxygen therapy initiation (baseline), Month 2, Month 3.5
measure: Impact of long term oxygen therapy on the respiratory function
timeFrame: At inclusion, Month 6
measure: Assessment of exacerbation
timeFrame: Month 6
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: CHIAP
city: Antibes
country: France
facility: Cabinet privé
city: Avignon
country: France
facility: Cabinet libéral
city: Avignon
country: France
facility: CH Avignon
city: Blois
country: France
facility: CH Blois
city: Briis-sous-Forges
country: France
facility: CH Bligny
city: Cannes
country: France
facility: CH Cannes
city: Clamart
country: France
facility: Hôpital Percy
city: Foix
country: France
facility: Cabinet libéral
city: Le Puy-en-Velay
country: France
facility: Cabinet libéral
city: Libourne
country: France
facility: CH Libourne
city: Lille
country: France
facility: Hôpital La Louvière
city: Lyon
country: France
facility: Centre médical Parot
city: Marseille
country: France
facility: Hôpital Saint Joseph
city: Marseille
country: France
facility: Hôpital d'Instruction des Armées Laveran
city: Marseille
country: France
facility: AP-HM Hopital nord
city: Montfermeil
country: France
facility: GHI Le Raincy
city: Nancy
country: France
facility: CHRU Nancy-Université de Lorraine
city: Ollioules
country: France
facility: Polyclinique des fleurs
city: Perpignan
country: France
facility: CH de Perpignan
city: Perpignan
country: France
facility: Pneumology practice
city: Pessac
country: France
facility: CHU de Bordeaux
city: Poissy
country: France
facility: Cabinet libéral
city: Sainte-Feyre
country: France
facility: MGEN
Study officials:
affiliation: CHRU Nancy-Université de Lorraine
name: Ari CHAOUAT, Pr
role: PRINCIPAL_INVESTIGATOR
References: