Innovative management strategy for COPD exacerbations
FreeDom : Innovative Strategy for the Management of COPD Exacerbations Combining Early Hospitalisation Discharge, Automated Oxygen Weaning at Home, Telemedicine and Tele-rehabilitation
This study is testing a new way to help people with COPD recover faster from flare-ups by using early hospital discharge, smart oxygen adjustments, and remote check-ins to see if it can cut hospital stays in half.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Laval University Academic / other |
| Locations | 1 site (Québec) |
| Trial ID | NCT03396172 on ClinicalTrials.gov |
What this trial studies
This study evaluates the FreeDom strategy, which combines early hospital discharge, automated oxygen flow adjustment using the FreeO2 system, and telemedicine to manage patients with COPD exacerbations. The goal is to reduce the length of hospital stays by 50% within 30 days of treatment. Patients will be monitored remotely to ensure effective management of their oxygen needs and rehabilitation. The approach aims to enhance patient autonomy and improve recovery outcomes.
Who should consider this trial
Good fit: Ideal candidates are hospitalized patients with COPD exacerbations who are over 40 years old and require moderate oxygen therapy.
Not a fit: Patients who are non-autonomous at home, have imminent intubation needs, or live more than 50 km from the hospital may not benefit from this study.
Why it matters
Potential benefit: If successful, this strategy could significantly reduce hospitalization duration for COPD patients, leading to improved quality of life and reduced healthcare costs.
How similar studies have performed: Other studies have shown promising results with telemedicine and home-based management strategies for COPD, indicating potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Québec
- Institut Universitaire de Cardiologie et de Pneumologie de Québec — Québec, Canada (Recruiting)
Study contacts
- Principal investigator: François Lellouche — Laval University
- Study coordinator: François Lellouche
- Email: francois.lellouche@criucpq.ulaval.ca
- Phone: 418-656-8711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.