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

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Behavioral: pharmaceutical care intervention

• Registration Number: NCT01260389
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-13
• Study First Submitted QC: 2010-12-13
• Study First Posted: 2010-12-15
• Primary Completion: 2011-05
• Study Completion: 2011-07
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-07
• Last Update Posted: 2021-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 734

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pharmaceutical care intervention	pharmaceutical care intervention	A pharmaceutical care intervention, focused at improving inhalation technique and drug adherence in patients with Chronic Obstructive Pulmonary Disease (COPD).

Primary Outcome Measures

Name	Time	Method
inhalation technique baseline	baseline	Inhalation technique with Chronic Obstructive Pulmonary Disease (COPD) controller medication at baseline.
inhalation technique 3 months	after 3 months	Inhalation technique with Chronic Obstructive Pulmonary Disease (COPD) controller medication after 3 months.
drug adherence	after 3 months	Adherence to Chronic Obstructive Pulmonary Disease (COPD) controller medication after 3 months.
inhalation technique 1 month	after 1 month	Inhalation technique with Chronic Obstructive Pulmonary Disease (COPD) controller medication after 1 month.

Secondary Outcome Measures

Name	Time	Method
exacerbations	after 3 months	Frequency of exacerbations measured over a 3 month period.
Emergency Room visits and hospitalizations.	after 3 months	Frequency of Emergency Room (ER) visits and hospitalizations measured over a 3 month period.
health status	after 3 months	Health status, measured by: the COPD Assessment Test, MRC Dyspnoea Scale and EQ-5D questionnaire.

Trial Locations

Locations (2)

Centre Hospitalier Universitaire du Sart Tilman; 🇧🇪 Liege, Belgium

Ghent University; 🇧🇪 Ghent, Belgium