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FreeDom Strategy for COPD Exacerbations

N/A

Recruiting

Led By François Lellouche

Research Sponsored by Laval University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Age > or = 40 years

Must not have

Non-autonomous and alone at home

Patient alone at home

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 and 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests an innovative strategy to reduce hospital stay for people with COPD by 50%, using early discharge, automated O2, telemedicine and tele-rehabilitation.

Who is the study for?

This trial is for COPD patients needing moderate oxygen therapy (<6L/min) to maintain SpO2 > 90%, hospitalized for less than 48 hours, aged over 40 with a history of smoking. It's not for those non-autonomous and alone at home, refusing consent, needing imminent intubation, with sleep apnea or living far from the hospital (>50 km).

What is being tested?

The 'FreeDom' strategy is being tested to cut hospital stays by half in COPD exacerbation cases. It includes early discharge, automated O2 weaning using FreeO2 system, telemedicine and tele-rehabilitation.

What are the potential side effects?

Potential side effects are not explicitly listed but may include issues related to changes in oxygen levels due to automated weaning and complications from reduced medical supervision post-discharge.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need less than 6L/min of oxygen to keep my oxygen levels above 90%.

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I am 40 years old or older.

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I was hospitalized for a severe COPD flare-up but stayed less than 48 hours.

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I have been diagnosed with or suspected to have COPD.

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I have smoked 10 or more packs a year in the past.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need help with daily activities and live alone.

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I live alone.

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I have been diagnosed with sleep apnea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 and 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 and 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The number of hospital days during COPD exacerbation at day 30.

Secondary study objectives

Cost of care at 3 months

Health Related Quality of Life

Number of consultations

+2 more

Side effects data

From 2012 Phase 4 trial • 200 Patients • NCT01342510

30%

Pain with injection of propofol

100%

80%

60%

40%

20%

Study treatment Arm

Lidocaine/Magnesium

Control

Lidocaine

Magnesium

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ControlExperimental Treatment1 Intervention

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

Group II: FreeDomActive Control1 Intervention

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,

0 / 8Eligibility criteria met