FreeDom: Innovative Strategy for the Management of COPD Exacerbations

NCT03396172 | Recruiting

• 1 other identifier: 21419
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxygen Deficiency; COPD Exacerbation

Keywords

COPD; Homecare; Oxygen; Telemedicine; Automated oxygen adjustment; Rehabilitation program

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Rate of Emergency consultation and hospital readmission

  1 and 3 months

• Health Related Quality of Life

  1 and 3 months

• Cost of care at 3 months

  3 months

• Oxygenation data (% of time in the SpO2 target, % of time with hypoxemia, % of time with hyperoxia)

  From inclusion to hospital discharge and from hospital discharge to the end of oxygen therapy (around one week after discharge)

• Number of consultations

  3 months

Study Arms (2)

Control

OTHER

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

FreeDom

ACTIVE COMPARATOR

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

Interventions

Control OTHER

The hospitalization will take place in the usual setting and the hospital discharge will be decided by pulmonologists according to the usual criteria

Also known as: Usual oxygen administration and usual hospitalization

Control

FreeDom DEVICE

Early return home, patients using an innovative device that automatically adjusts and wean the oxygen flow (FreeO2 system) coupled to telemedicine and tele-rehabilitation

Also known as: Early Hospital discharge with home hospitalisation

FreeDom

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, G1V4G5, Canada

RECRUITING

MeSH Terms

Conditions

Hypoxia; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• François Lellouche

  Laval University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

François Lellouche

CONTACT

418-656-8711; francois.lellouche@criucpq.ulaval.ca

Pierre-alexandre Bouchard

CONTACT

418-656-8711; pierre-alexandre.bouchard@criucpq.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: January 10, 2018
• Study Start: May 24, 2018
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

CA (1)