Clinical trial NCT03396172: FreeDom: Innovative Strategy for the Management of COPD Exacerbations
Official title: FreeDom : Innovative Strategy for the Management of COPD Exacerbations Combining Early Hospitalisation Discharge, Automated Oxygen Weaning at Home, Telemedicine and Tele-rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oxygen Deficiency
COPD Exacerbation
Keywords: COPD
Homecare
Oxygen
Telemedicine
Automated oxygen adjustment
Rehabilitation program
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2018-01-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The number of hospital days during COPD exacerbation at day 30.
timeFrame: 30 days
Secondary outcomes:
measure: Rate of Emergency consultation and hospital readmission
timeFrame: 1 and 3 months
measure: Health Related Quality of Life
timeFrame: 1 and 3 months
measure: Cost of care at 3 months
timeFrame: 3 months
measure: Oxygenation data (% of time in the SpO2 target, % of time with hypoxemia, % of time with hyperoxia)
timeFrame: From inclusion to hospital discharge and from hospital discharge to the end of oxygen therapy (around one week after discharge)
measure: Number of consultations
timeFrame: 3 months
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec
Study officials:
affiliation: Laval University
name: François Lellouche
role: PRINCIPAL_INVESTIGATOR
References: