FreeDom: Innovative Strategy for the Management of COPD Exacerbations

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Oxygen Deficiency, COPD Exacerbation

Intervention / Treatment
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* Other: Control
* Device: FreeDom


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>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 | Other: Control<br>* The hospitalization will take place in the usual setting and the hospital discharge will be decided by pulmonologists according to the usual criteria<br>* Other names: Usual oxygen administration and usual hospitalization;|
| Active Comparator: FreeDom<br>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, | Device: FreeDom<br>* Early return home, patients using an innovative device that automatically adjusts and wean the oxygen flow (FreeO2 system) coupled to telemedicine and tele-rehabilitation<br>* Other names: Early Hospital discharge with home hospitalisation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Emergency consultation and hospital readmission | Rate of Emergency consultation and hospital readmission | 1 and 3 months | 
| Health Related Quality of Life | Survey of health related quality of life | 1 and 3 months | 
| 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 | 
| 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) | 
| Number of consultations | Number of consultation : phone call, video consultation, rehabilitation, home visit | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Homecare, Oxygen, Telemedicine, Automated oxygen adjustment, Rehabilitation program