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FreeDom: Innovative Strategy for the Management of COPD Exacerbations

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ClinicalTrials.gov Identifier: NCT03396172
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
François Lellouche, Laval University

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.


Condition or disease Intervention/treatment Phase
Oxygen Deficiency COPD Exacerbation Other: Control Device: FreeDom Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Control
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
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,

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
Other Name: Early Hospital discharge with home hospitalisation




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Rate of Emergency consultation and hospital readmission [ Time Frame: 1 and 3 months ]
    Rate of Emergency consultation and hospital readmission

  2. Health Related Quality of Life [ Time Frame: 1 and 3 months ]
    Survey of health related quality of life

  3. 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

  4. 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%)

  5. Number of consultations [ Time Frame: 3 months ]
    Number of consultation : phone call, video consultation, rehabilitation, home visit



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: François Lellouche 418-656-8711 ext 3572 francois.lellouche@criucpq.ulaval.ca
Contact: Pierre-alexandre Bouchard 418-656-8711 ext 2712 pierre-alexandre.bouchard@criucpq.ulaval.ca

Locations
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Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec Recruiting
Quebec, Canada, G1V4G5
Contact: Francois Lellouche       francois.lellouche@criucpq.ulaval.ca   
Sponsors and Collaborators
Laval University
Investigators
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Principal Investigator: François Lellouche Laval University

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Responsible Party: François Lellouche, Principal Investigator, Laval University
ClinicalTrials.gov Identifier: NCT03396172     History of Changes
Other Study ID Numbers: 21419
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by François Lellouche, Laval University:
COPD
Homecare
Oxygen
Telemedicine
Automated oxygen adjustment
Rehabilitation program

Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Hypoxia
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms