FreeDom: Innovative Strategy for the Management of COPD Exacerbations
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaval University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Refusal to consent to participate in the study,
Indication for an imminent intubation according to the pulmonologist,
Sleep Apnea
NIV used at home
Trial design
Design model
Parallel
Treatments tested in this trial
Control
Other interventionThe hospitalization will take place in the usual setting and the hospital discharge will be decided by pulmonologists according to the usual criteria
FreeDom
DeviceEarly return home, patients using an innovative device that automatically adjusts and wean the oxygen flow (FreeO2 system) coupled to telemedicine and tele-rehabilitation
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: ControlOther 1 intervention
Group B: FreeDomActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The number of hospital days during COPD exacerbation at day 30.
The objective of the study is to reduced the hospitalisation days by 50 % at day 30 during COPD exacerbation
Time frame
30 daysSecondary outcomes
1
Rate of Emergency consultation and hospital readmission
Rate of Emergency consultation and hospital readmission
Time frame
1 and 3 months2
Health Related Quality of Life
Survey of health related quality of life
Time frame
1 and 3 months3
Cost of care at 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
Time frame
3 months4
Oxygenation data (% of time in the SpO2 target, % of time with hypoxemia, % of time with hyperoxia)
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%)
Time frame
From inclusion to hospital discharge and from hospital discharge to the end of oxygen therapy (around one week after discharge)Sponsors and contacts
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Source ClinicalTrials.gov