NCT03396172.
| Study name | FreeDom: innovative strategy for the management of COPD exacerbations combining early hospitalisation discharge, automated oxygen weaning at home, telemedicine, and telerehabilitation |
| Methods |
Study design: unknown centres, open‐blinding, parallel individual randomised controlled trial in Canada Duration: 12 weeks Setting: hospital |
| Participants |
Population: 100 patients recruited from hospitals in Canada Baseline characteristics: unknown Inclusion criteria: diagnosis of COPD, ex‐smoker (10 pack‐year history), acute exacerbation (< 15 days), oxygen therapy need (rate < 6 L/min for SpO₂ > 90%), ≥ 40 years of age Exclusion criteria: no consent, imminent intubation per pulmonologists, sleep apnoea, NIV used at home, non‐autonomous and alone at home, lives > 50 km from hospital, already in the study within 3 months, lack of free O₂ system at time of study |
| Interventions |
Run‐in: at hospital before discharge. Measurements taken at baseline and at 1 and 3 months Treatment arms
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| Outcomes |
Primary outcomes: number of hospital days during COPD exacerbation Secondary outcomes: emergency department visits, hospital re‐admissions, HRQL, costs of care, oxygenation, number of consultations (phone, video, rehab, home) |
| Starting date | 05.24.2018 |
| Contact information | Francois Lellouche, 418‐656‐8711 ext 3572, francois.lellouche@criucpq.ulaval.ca; Pierre‐alexandre Bouchard, 418‐656‐8711 ext 2712, pierre‐alexandre.bouchard@criucpq.ulaval.ca |
| Notes |
Funding: Laval University Other identifier:NCT03396172; 21419 |