Comprehensive Disease Management Program in Chronic Obstructive Pulmonary Disease (COPD) Patients in the Community

Study Overview
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Brief Summary
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The purpose of this study is to determine whether comprehensive disease management program combined with best care recommended in clinical guidelines, is more effective than best care alone in patients with advanced chronic obstructive pulmonary disease (COPD).

Detailed Description
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The study objective is to evaluate the effectiveness of a comprehensive program among patients with advanced COPD, implemented by a multi-disciplinary team. The program consists of best care recommended in clinical guidelines, combined with disease management, compared to best care only. The program will include designated COPD centers operated by multi-disciplinary teams (pulmonologists, nurse practitioners, physiotherapists, social workers and dietitians). Disease management will be provided in these centers by qualified designated nurses.

Official Title
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Comprehensive Disease Management Program in COPD Patients in the Community: Randomized Controlled Trial

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Other: Disease management
* Other: Best care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 40 years or older Advanced COPD Exclusion Criteria: Permanent tracheostomy Heart failure with significant left-ventricular dysfunction Severe other chronic disease Significant cognitive impairment, Drug or alcohol abuse, inability to cooperate No telephone or permanent address Bedridden Refusal to use telemonitoring equipment Participation in another clinical trial

Ages Eligible for Study
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Minimum Age: 40 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<br>Comprehensive disease management in addition to best care according to clinical guidelines for COPD patients | Other: Disease management<br>* Disease management by COPD nurses, including active follow-up and coordination of care in addition to best care according to clinical guidelines for COPD patients<br>|
| Active Comparator: Best care<br>Best care according to clinical guidelines for COPD patients | Other: Best care<br>* Comprehensive care for COPD patients recommended in clinical guidelines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital admission for acute exacerbation of COPD or all-cause mortality |  | Within 2 to 5 years after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total days of hospitalization for acute exacerbations of COPD |  | Within 2 to 5 years after randomization | 
| Quality of life |  | Within 2 to 5 years after randomization | 
| Total number of acute exacerbations of COPD |  | Within 2 to 5 years after randomization | 
| Depression |  | Within 2 to 5 years after randomization | 
| Functional capacity |  | Within 2 to 5 years after randomization | 
| Spirometry parameters |  | Within 2 to 5 years after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic obstructive pulmonary disease, Disease management, Pulmonary rehabilitation, Quality of life