Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
161 participants
OBSERVATIONAL
2023-01-27
2026-01-15
Brief Summary
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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
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 with cognitive impairment.
* Simultaneous participation in a health intervention research,
* Vulnerable subjects.
18 Years
ALL
No
Sponsors
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Slb Pharma
OTHER
Vivisol
OTHER
Responsible Party
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Principal Investigators
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Ari CHAOUAT, Pr
Role: PRINCIPAL_INVESTIGATOR
CHRU Nancy-Université de Lorraine
Locations
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CHIAP
Aix-en-Provence, , France
CH Nord Ardèche
Annonay, , France
Cabinet privé
Antibes, , France
Hopital Privé de La Casamance
Aubagne, , France
Cabinet libéral
Avignon, , France
CH Avignon
Avignon, , France
CH Blois
Blois, , France
CH Bligny
Briis-sous-Forges, , France
CH Cannes
Cannes, , France
Hôpital Percy
Clamart, , France
CHU Gabriel Montpied
Clermont-Ferrand, , France
CH Draguignan
Draguignan, , France
Cabinet libéral
Foix, , France
CH Emile Roux
Le Puy-en-Velay, , France
Cabinet libéral
Le Puy-en-Velay, , France
CH Libourne
Libourne, , France
Hôpital La Louvière
Lille, , France
Centre médical Parot
Lyon, , France
Hôpital Saint Joseph
Marseille, , France
Hôpital d'Instruction des Armées Laveran
Marseille, , France
AP-HM Hopital nord
Marseille, , France
CH de Martigues
Martigues, , France
GHSIF / CH Melun
Melun, , France
GHI Le Raincy
Montfermeil, , France
CHRU Nancy-Université de Lorraine
Nancy, , France
Polyclinique des fleurs
Ollioules, , France
CH Louis Giorgi d'Orange
Orange, , France
CH de Perpignan
Perpignan, , France
Pneumology practice
Perpignan, , France
CHU de Bordeaux
Pessac, , France
Cabinet libéral
Poissy, , France
CH St Nazaire
Saint-Nazaire, , France
MGEN
Sainte-Feyre, , France
cabinet du dr Radu Horia Bumbea
Sallanches, , France
Cabinet de Pneumologie
Toulon, , France
Clinique Pasteur
Toulouse, , France
Countries
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Other Identifiers
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IDRCB 2022-A00825-38
Identifier Type: OTHER
Identifier Source: secondary_id
O2 Connect
Identifier Type: -
Identifier Source: org_study_id