FreeDom: Innovative Strategy for the Management of COPD Exacerbations
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03396172|
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : February 26, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Oxygen Deficiency COPD Exacerbation||Other: Control Device: FreeDom||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||FreeDom : Innovative Strategy for the Management of COPD Exacerbations Combining Early Hospitalisation Discharge, Automated Oxygen Weaning at Home, Telemedicine and Tele-rehabilitation|
|Actual Study Start Date :||May 24, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
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
Other Name: Usual oxygen administration and usual hospitalization
Active Comparator: 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
Other Name: Early Hospital discharge with home hospitalisation
- The number of hospital days during COPD exacerbation at day 30. [ Time Frame: 30 days ]The objective of the study is to reduced the hospitalisation days by 50 % at day 30 during COPD exacerbation
- Rate of Emergency consultation and hospital readmission [ Time Frame: 1 and 3 months ]Rate of Emergency consultation and hospital readmission
- Health Related Quality of Life [ Time Frame: 1 and 3 months ]Survey of health related quality of life
- Cost of care at 3 months [ Time Frame: 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
- Oxygenation data (% of time in the SpO2 target, % of time with hypoxemia, % of time with hyperoxia) [ Time Frame: 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%)
- Number of consultations [ Time Frame: 3 months ]Number of consultation : phone call, video consultation, rehabilitation, home visit
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03396172
|Contact: François Lellouche||418-656-8711 ext email@example.com|
|Contact: Pierre-alexandre Bouchard||418-656-8711 ext firstname.lastname@example.org|
|Institut Universitaire de Cardiologie et de Pneumologie de Québec||Recruiting|
|Quebec, Canada, G1V4G5|
|Contact: Francois Lellouche email@example.com|
|Principal Investigator:||François Lellouche||Laval University|