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FreeDom: Innovative Strategy for the Management of COPD Exacerbations

Primary Purpose

Oxygen Deficiency, COPD Exacerbation

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Control
FreeDom
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oxygen Deficiency focused on measuring COPD, Homecare, Oxygen, Telemedicine, Automated oxygen adjustment, Rehabilitation program

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Universitaire de Cardiologie et de Pneumologie de QuébecRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Control

FreeDom

Arm Description

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

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,

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rate of Emergency consultation and hospital readmission
Rate of Emergency consultation and hospital readmission
Health Related Quality of Life
Survey of health related quality of life
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
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%)
Number of consultations
Number of consultation : phone call, video consultation, rehabilitation, home visit

Full Information

First Posted
December 18, 2017
Last Updated
April 3, 2023
Sponsor
Laval University
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1. Study Identification

Unique Protocol Identification Number
NCT03396172
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2018 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxygen Deficiency, COPD Exacerbation
Keywords
COPD, Homecare, Oxygen, Telemedicine, Automated oxygen adjustment, Rehabilitation program

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
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
Arm Title
FreeDom
Arm Type
Active Comparator
Arm Description
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,
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
Usual oxygen administration and usual hospitalization
Intervention Description
The hospitalization will take place in the usual setting and the hospital discharge will be decided by pulmonologists according to the usual criteria
Intervention Type
Device
Intervention Name(s)
FreeDom
Other Intervention Name(s)
Early Hospital discharge with home hospitalisation
Intervention Description
Early return home, patients using an innovative device that automatically adjusts and wean the oxygen flow (FreeO2 system) coupled to telemedicine and tele-rehabilitation
Primary Outcome Measure Information:
Title
The number of hospital days during COPD exacerbation at day 30.
Description
The objective of the study is to reduced the hospitalisation days by 50 % at day 30 during COPD exacerbation
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Rate of Emergency consultation and hospital readmission
Description
Rate of Emergency consultation and hospital readmission
Time Frame
1 and 3 months
Title
Health Related Quality of Life
Description
Survey of health related quality of life
Time Frame
1 and 3 months
Title
Cost of care at 3 months
Description
Economic evaluation about these 2 different strategy of COPD exacerbation management using micro-costing approach and including the cost of the FreeO2 technology
Time Frame
3 months
Title
Oxygenation data (% of time in the SpO2 target, % of time with hypoxemia, % of time with hyperoxia)
Description
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%)
Time Frame
From inclusion to hospital discharge and from hospital discharge to the end of oxygen therapy (around one week after discharge)
Title
Number of consultations
Description
Number of consultation : phone call, video consultation, rehabilitation, home visit
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
François Lellouche
Phone
418-656-8711
Ext
3572
Email
francois.lellouche@criucpq.ulaval.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre-alexandre Bouchard
Phone
418-656-8711
Ext
2712
Email
pierre-alexandre.bouchard@criucpq.ulaval.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Lellouche
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Québec
City
Quebec
ZIP/Postal Code
G1V4G5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francois Lellouche
Email
francois.lellouche@criucpq.ulaval.ca

12. IPD Sharing Statement

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FreeDom: Innovative Strategy for the Management of COPD Exacerbations

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