FreeDom: Innovative Strategy for the Management of COPD Exacerbations
NCT ID: NCT03396172
Last Updated: 2024-06-18
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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RECRUITING
NA
100 participants
INTERVENTIONAL
2018-05-24
2025-12-31
Brief Summary
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The main hypothesis of this study is that the FreeDom strategy will reduce the number of hospitalization day by 50 percent at day 30.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Control
The hospitalization will take place in the usual setting and the hospital discharge will be decided by pulmonologists according to the usual criteria
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,
FreeDom
Early return home, patients using an innovative device that automatically adjusts and wean the oxygen flow (FreeO2 system) coupled to telemedicine and tele-rehabilitation
Interventions
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Control
The hospitalization will take place in the usual setting and the hospital discharge will be decided by pulmonologists according to the usual criteria
FreeDom
Early return home, patients using an innovative device that automatically adjusts and wean the oxygen flow (FreeO2 system) coupled to telemedicine and tele-rehabilitation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Laval University
OTHER
Responsible Party
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François Lellouche
Principal Investigator
Principal Investigators
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François Lellouche
Role: PRINCIPAL_INVESTIGATOR
Laval University
Locations
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Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, , Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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21419
Identifier Type: -
Identifier Source: org_study_id
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