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An International Phase IV Randomised Trial for Medical and Medico-economic Evaluations of Home-based Disease Management Program in Patients With Gold III/IV Chronic Obstructive Pulmonary Disease.
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.
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.
Age
35 - No limit years
Sex
ALL
Healthy Volunteers
No
Centre Hospitalier d Antibes Juans-les-pins
Antibes, France
Hôpitaux Civils de Colmar - Hôpital Pasteur
Colmar, France
CHU de Grenoble
Grenoble, France
Centre Hospitalier du Mans
Le Mans, France
Hôpital de la Croix Rousse
Lyon, France
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
Marseille, France
Hôpital MERCY
Metz, France
Hôpital Saint Louis
Paris, France
Groupe Hospitalier Pitié-Salpétrière
Paris, France
Groupe Hospitalier Saint Joseph
Paris, France
Start Date
September 1, 2010
Primary Completion Date
February 1, 2015
Completion Date
October 1, 2015
Last Updated
January 14, 2016
346
ACTUAL participants
Disease Management
OTHER
Usual site management
OTHER
Lead Sponsor
Air Liquide Santé International
Collaborators
NCT07477600
NCT07382258
NCT07195838
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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