Vrijheid: innovatieve strategie voor het beheer van COPD-exacerbaties
FreeDom: innovatieve strategie voor de behandeling van COPD-exacerbaties, waarbij vroegtijdig ontslag uit het ziekenhuis, geautomatiseerde zuurstofontwenning thuis, telegeneeskunde en telerevalidatie worden gecombineerd
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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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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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Ander: 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
Andere namen:
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Actieve vergelijker: 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
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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The number of hospital days during COPD exacerbation at day 30.
Tijdsspanne: 30 days
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The objective of the study is to reduced the hospitalisation days by 50 % at day 30 during COPD exacerbation |
30 days
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Rate of Emergency consultation and hospital readmission
Tijdsspanne: 1 and 3 months
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Rate of Emergency consultation and hospital readmission |
1 and 3 months
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Health Related Quality of Life
Tijdsspanne: 1 and 3 months
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Survey of health related quality of life |
1 and 3 months
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Cost of care at 3 months
Tijdsspanne: 3 months
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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)
Tijdsspanne: From inclusion to hospital discharge and from hospital discharge to the end of oxygen therapy (around one week after discharge)
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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
Tijdsspanne: 3 months
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Number of consultation : phone call, video consultation, rehabilitation, home visit |
3 months
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: François Lellouche, Laval University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 21419
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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