The COPD Patient Management European Trial (COMET)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Other: Usual site managementOther: Disease Management
- Registration Number
- NCT01241526
- Lead Sponsor
- Air Liquide Santé International
- Brief Summary
The goal of the study is to evaluate a Home-Based Disease Management program specifically developed for patients with Gold III/IV COPD.
By improving disease knowledge, awareness of significant clinical deterioration and self-management skills for patients, this Home-Based COPD Management Program is expected to reduce the severity of exacerbations, the need for emergency hospitalisations, thus demonstrating the efficacy and the cost effectiveness of this intervention.
- Detailed Description
Primary objective: To evaluate a strategy of Chronic Obstructive Pulmonary Disease (COPD) management to reduce the number of hospital days in patients with severe Gold III/IV COPD: a Home-Based COPD Management Program versus usual patient education and follow-up.
Secondary objectives:
* To assess the clinical outcome and the health-related quality of life,
* To assess safety,
* To evaluate medico-economic impact.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 346
- Confirmed Gold III/IV COPD
- Current or ex-smoker with a smoking history ≥ 10 pack-years
- At least one COPD exacerbation leading to hospitalization in the year before selection.
- LTOT for another reason than COPD
- Severe concomitant disorder associated with a limited probability of survival (< 6 months)
- Tracheostomy
- Long term oral corticosteroids therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual site management Usual site management - Disease management program Disease Management -
- Primary Outcome Measures
Name Time Method Number of unscheduled hospital days up to 12 months
- Secondary Outcome Measures
Name Time Method Medico-economic data up to 12 months Cost estimation, Cost-effectiveness, Cost-utility.
Health related quality of life up to 12 months Safety parameters up to 12 months Adverse Events (AEs)
Use of health care services up to 12 months Compliance to oxygen therapy up to 12 months Number of hospital days due to severe COPD exacerbation up to 12 months
Trial Locations
- Locations (34)
Centre Hospitalier d Antibes Juans-les-pins
🇫🇷Antibes, France
Hôpitaux Civils de Colmar - Hôpital Pasteur
🇫🇷Colmar, France
Centre Hospitalier du Mans
🇫🇷Le Mans, France
CHU de Grenoble
🇫🇷Grenoble, France
Hôpital de la Croix Rousse
🇫🇷Lyon, France
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
🇫🇷Marseille, France
Groupe Hospitalier Saint Joseph
🇫🇷Paris Cedex 14, France
Groupe Hospitalier Pitié-Salpétrière
🇫🇷Paris, France
Hôpital Beauregard - CHR METZ
🇫🇷Thionville, France
Hôpital MERCY
🇫🇷Metz, France
Hôpital Civil de Strasbourg
🇫🇷Strasbourg, France
Lungenklinik Hemer
🇩🇪Hemer, Germany
Helios Hagen-Ambrock
🇩🇪Hagen, Germany
Universitatklinikum
🇩🇪Aachen, Germany
Marien Krankenhaus
🇩🇪Kassel, Hesse, Germany
Thoraxklinik Heidelberg gGmbh
🇩🇪Heidelberg, Germany
Fachkrankenhaus Kloster Grafschaft
🇩🇪Schmallenberg, Germany
Klinik für Pneumologie und Allergologie
🇩🇪Solingen, Germany
Universitätsklinikum Ulm, - Klinik Innere Medizin II
🇩🇪ULM, Germany
Azienda ospedialiera Di DESIO Vimercate
🇮🇹Seregno, Italy
Hospital Universitario de Burgos
🇪🇸Burgos, Spain
Hospital San Pedro de Alcantara
🇪🇸Caceres, Spain
Hospital Arnau de Vilanova
🇪🇸Valencia, Spain
Hospital Universitario de Asturia
🇪🇸Oviedo, Spain
Azienda ULSS 22 - Ospedale di Bussolengo
🇮🇹Bussolengo, Italy
"Azienda Ospedaliera Niguarda
🇮🇹Milano, Italy
Azienda Ospedaliera, "Ospedale San Carlo Borromeo"
🇮🇹Milan, Italy
Hôpital Sainte Musse
🇫🇷Toulon, France
ASL Viterbo
🇮🇹Civita Castellana, Italy
Ospedale di Macerata
🇮🇹Macerata, Italy
Hospital La Princessa
🇪🇸Madrid, Spain
Hospital Gregorio Maranon
🇪🇸Madrid, Spain
Hôpital Saint Louis
🇫🇷Paris, France
Hospital Ramon Y Cajal
🇪🇸Madrid, Spain