FreeDom: Innovative Strategy for the Management of COPD Exacerbations

COPD Exacerbation Clinical Trial

Official title:

FreeDom : Innovative Strategy for the Management of COPD Exacerbations Combining Early Hospitalisation Discharge, Automated Oxygen Weaning at Home, Telemedicine and Tele-rehabilitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03396172
• Other study ID #: 21419
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2018
• Est. completion date: December 2025

Study information

• Verified date: April 2023
• Source: Laval University
• Contact: François Lellouche
• Phone: 418-656-8711
• Email: francois.lellouche[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD Exacerbation
• Hypoxia
• Oxygen Deficiency
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Control
The hospitalization will take place in the usual setting and the hospital discharge will be decided by pulmonologists according to the usual criteria

Device:
• 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

Locations

Country	Name	City	State
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days
Secondary	Rate of Emergency consultation and hospital readmission	Rate of Emergency consultation and hospital readmission	1 and 3 months
Secondary	Health Related Quality of Life	Survey of health related quality of life	1 and 3 months
Secondary	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	3 months
Secondary	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%)	From inclusion to hospital discharge and from hospital discharge to the end of oxygen therapy (around one week after discharge)
Secondary	Number of consultations	Number of consultation : phone call, video consultation, rehabilitation, home visit	3 months