The COPD Patient Management European Trial (COMET)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Other: Disease Management
* Other: Usual site management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Disease management program<br> | Other: Disease Management<br>* Individual, group and phone education sessions Telephone supporter follow-up LTOT monitoring<br>* Other names: Living Well With COPD Disease Management Program;|
| Active Comparator: Usual site management<br> | Other: Usual site management<br>* Usual education as per site protocol Usual follow-up as per site protocol LTOT monitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of unscheduled hospital days |  | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hospital days due to severe COPD exacerbation |  | up to 12 months | 
| Safety parameters | Adverse Events (AEs) | up to 12 months | 
| Medico-economic data | Cost estimation, Cost-effectiveness, Cost-utility. | up to 12 months | 
| Health related quality of life |  | up to 12 months | 
| Use of health care services |  | up to 12 months | 
| Compliance to oxygen therapy |  | up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, COMET, Disease management