FreeDom: Innovative Strategy for the Management of COPD Exacerbations

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

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.

Study Overview

• Status: Recruiting
• Conditions: Oxygen Deficiency; COPD Exacerbation
• Intervention / Treatment: Other: Control; Device: FreeDom

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V4G5
    • Recruiting
    • Institut Universitaire De Cardiologie Et De Pneumologie De Québec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: 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 Names: Early Hospital discharge with home hospitalisation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Laval University

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2018
• Primary Completion (Anticipated): June 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: December 18, 2017
• First Submitted That Met QC Criteria: January 9, 2018
• First Posted (Actual): January 10, 2018

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Telemedicine; COPD; Rehabilitation program; Oxygen; Homecare; Automated oxygen adjustment
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Signs and Symptoms, Respiratory; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Hypoxia
• Other Study ID Numbers: 21419

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No