Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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