Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
COPD, COMET, Disease management
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.
Interventions
OTHERDisease Management
* Individual, group and phone education sessions * Telephone supporter follow-up * LTOT monitoring
OTHERUsual site management
* Usual education as per site protocol * Usual follow-up as per site protocol * LTOT monitoring
Sponsors
ITEC Services
Lincoln Medical and Mental Health Center
Air Liquide Santé International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* LTOT for another reason than COPD * Severe concomitant disorder associated with a limited probability of survival (\< 6 months) * Tracheostomy * Long term oral corticosteroids therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of unscheduled hospital days | up to 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety parameters | up to 12 months | Adverse Events (AEs) |
| Medico-economic data | up to 12 months | Cost estimation, Cost-effectiveness, Cost-utility. |
| Number of hospital days due to severe COPD exacerbation | up to 12 months | — |
| Use of health care services | up to 12 months | — |
| Compliance to oxygen therapy | up to 12 months | — |
| Health related quality of life | up to 12 months | — |
Countries
France, Germany, Italy, Spain
Outcome results
None listed