Pharmaceutical Care for Chronic Obstructive Pulmonary Disease (COPD) Study.

Study Overview
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Brief Summary
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This study would like to test the hypothesis that a pharmaceutical care intervention would result in an improved drug adherence and inhalation technique in Chronic Obstructive Pulmonary Disease (COPD) patients over a 3 month-period.

Detailed Description
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Effective pharmacologic management of Chronic Obstructive Pulmonary Disease (COPD) not only involves prescription of recommended medicines by the physician, but also implies correct use of the prescribed medication by the patient (ie, good drug adherence and correct inhalation technique). Community pharmacists could help to improve the latter aspect, by delivering pharmaceutical care. The present randomised controlled trial will study the hypothesis that a pharmaceutical care intervention would result in an improved drug adherence and inhalation technique in COPD patients over a 3 month-period.

Official Title
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Pharmaceutical Care for COPD Study

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Behavioral: pharmaceutical care intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: daily use of Chronic Obstructive Pulmonary Disease (COPD)-medication: (Global initiative for chronic Obstructive Lung Disease: GOLD stadia I-IV) 50 years of age or older smoking history of at least 10 pack-years Exclusion Criteria: having asthma analphabetism

Ages Eligible for Study
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Minimum Age: 50 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>Usual pharmacist care in patients with Chronic Obstructive Pulmonary Disease (COPD). | |
| Experimental: pharmaceutical care intervention<br>A pharmaceutical care intervention, focused at improving inhalation technique and drug adherence in patients with Chronic Obstructive Pulmonary Disease (COPD). | Behavioral: pharmaceutical care intervention<br>* Pharmaceutical care intervention, focused at improving inhalation technique and drug adherence in patients with Chronic Obstructive Pulmonary Disease (COPD).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inhalation technique baseline | Inhalation technique with Chronic Obstructive Pulmonary Disease (COPD) controller medication at baseline. | baseline | 
| inhalation technique 1 month | Inhalation technique with Chronic Obstructive Pulmonary Disease (COPD) controller medication after 1 month. | after 1 month | 
| inhalation technique 3 months | Inhalation technique with Chronic Obstructive Pulmonary Disease (COPD) controller medication after 3 months. | after 3 months | 
| drug adherence | Adherence to Chronic Obstructive Pulmonary Disease (COPD) controller medication after 3 months. | after 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| health status | Health status, measured by: the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test, Medical Research Council (MRC) Dyspnoea Scale and Euro Quality of Life (EQ-5D) questionnaire. | baseline | 
| health status | Health status, measured by: the COPD Assessment Test, MRC Dyspnoea Scale. | after 1 month | 
| health status | Health status, measured by: the COPD Assessment Test, MRC Dyspnoea Scale and EQ-5D questionnaire. | after 3 months | 
| exacerbations | Frequency of exacerbations measured over a 3 month period. | after 3 months | 
| Emergency Room visits and hospitalizations. | Frequency of Emergency Room (ER) visits and hospitalizations measured over a 3 month period. | after 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease, COPD