FreeDom : stratégie innovante pour la gestion des exacerbations de la MPOC
FreeDom : Stratégie innovante de prise en charge des exacerbations de BPCO associant sortie d'hospitalisation précoce, sevrage automatisé à l'oxygène à domicile, télémédecine et télérééducation
The main objective of the study is to assess the "FreeDom" innovative strategy (FreeO2 at Domicile) to reduce hospitalization duration in patients with COPD exacerbation. This strategy associates early hospital discharge, automated O2 flow weaning with FreeO2 system, telemedicine and tele-rehabilitation.
The main hypothesis of this study is that the FreeDom strategy will reduce the number of hospitalization day by 50 percent at day 30.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The main objective of the study is to assess the "FreeDom" innovative strategy (FreeO2 at Domicile) to reduce hospitalization duration in patients with COPD exacerbation. This strategy will enable an early return home, patients using an innovative device that automatically adjusts and wean the oxygen flow (FreeO2 system) coupled to telemedicine and tele-rehabilitation.
The main hypothesis of this study is that a strategy for an early return home with a home hospitalization managed by telemedicine will reduce the length of hospitalization by 50 percent from 30 days.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Quebec
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Québec, Quebec, Canada, G1V4G5
- Institut Universitaire de Cardiologie et de Pneumologie de Québec
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
All patients hospitalized for COPD exacerbation for less than 48 hours will be considered.
- known or suspected COPD to entry
- Age > or = 40 years
- Ex-smoker history (10 pack / year or more)
- Acute Exacerbation: dyspnea of recent onset (less than 15 days)
- The need for oxygen therapy with a moderate rate: <6L / min to maintain SpO2 > 90% (for oxygen dependent patient, the oxygen flow must be higher than flow at home)
Exclusion Criteria:
- Refusal to consent to participate in the study,
- Indication for an imminent intubation according to the pulmonologist,
- Sleep Apnea
- NIV used at home
- Lack of FreeO2 system available at the time of randomization
- Non-autonomous and alone at home
- Patient alone at home
- Patients who live more than 50 km from the hospital
- Patient already included in the study within 3 months
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: Control
The intervention is an hospitalization with usual care. The hospitalization will take place in the usual setting and the hospital discharge will be decided by pulmonologists according to the usual criteria |
The hospitalization will take place in the usual setting and the hospital discharge will be decided by pulmonologists according to the usual criteria
Autres noms:
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Comparateur actif: FreeDom
FreeDom strategy (early discharge, automated weaning at home, telemedicine, telereadaptation): -initial conventional hospitalization before discharge home, O2 flow rate automatically titrated by FreeO2 (based on a SpO2 target). The hospital discharge will be possible if the definite criteria are met. After hospital discharge, patient will have home hospitalisation. Automated oxygen flow titration, patient education will be conducted for using the telemedicine system, for questionnaires and for the tele-rehabilitation program will be initiated for home hospitalization, |
Early return home, patients using an innovative device that automatically adjusts and wean the oxygen flow (FreeO2 system) coupled to telemedicine and tele-rehabilitation
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The number of hospital days during COPD exacerbation at day 30.
Délai: 30 days
|
The objective of the study is to reduced the hospitalisation days by 50 % at day 30 during COPD exacerbation |
30 days
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Rate of Emergency consultation and hospital readmission
Délai: 1 and 3 months
|
Rate of Emergency consultation and hospital readmission |
1 and 3 months
|
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Health Related Quality of Life
Délai: 1 and 3 months
|
Survey of health related quality of life |
1 and 3 months
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Cost of care at 3 months
Délai: 3 months
|
Economic evaluation about these 2 different strategy of COPD exacerbation management using micro-costing approach and including the cost of the FreeO2 technology |
3 months
|
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Oxygenation data (% of time in the SpO2 target, % of time with hypoxemia, % of time with hyperoxia)
Délai: From inclusion to hospital discharge and from hospital discharge to the end of oxygen therapy (around one week after discharge)
|
The continuous measurement of SpO2 and O2 flow rate with the FreeO2 device (only in the FreeDom strategy) will allow the calculation of the % of time within the SpO2 target (recorded in the FreeO2) ± 2%, with hypoxemia (% of time with SpO2 < 85%) and with hyperoxia (% of time above SpO2 target +5%) |
From inclusion to hospital discharge and from hospital discharge to the end of oxygen therapy (around one week after discharge)
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Number of consultations
Délai: 3 months
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Number of consultation : phone call, video consultation, rehabilitation, home visit |
3 months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: François Lellouche, Laval University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Maladie chronique
- Attributs de la maladie
- Maladies des voies respiratoires
- Maladies pulmonaires
- Maladies pulmonaires obstructives
- Signes et symptômes respiratoires
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Maladie pulmonaire obstructive chronique
- Hypoxie
Autres numéros d'identification d'étude
- 21419
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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