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

Overview

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.

Full Title of Study: “Pharmaceutical Care for COPD Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2011

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.

Interventions

  • Behavioral: control
    • usual pharmacist care
  • Behavioral: pharmaceutical care intervention
    • Pharmaceutical care intervention, focused at improving inhalation technique and drug adherence in patients with Chronic Obstructive Pulmonary Disease (COPD).

Arms, Groups and Cohorts

  • No Intervention: control group
    • Usual pharmacist care in patients with Chronic Obstructive Pulmonary Disease (COPD).
  • Experimental: pharmaceutical care intervention
    • A pharmaceutical care intervention, focused at improving inhalation technique and drug adherence in patients with Chronic Obstructive Pulmonary Disease (COPD).

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • health status
    • Time Frame: baseline
    • 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.
  • health status
    • Time Frame: after 1 month
    • Health status, measured by: the COPD Assessment Test, MRC Dyspnoea Scale.
  • health status
    • Time Frame: after 3 months
    • Health status, measured by: the COPD Assessment Test, MRC Dyspnoea Scale and EQ-5D questionnaire.
  • exacerbations
    • Time Frame: after 3 months
    • Frequency of exacerbations measured over a 3 month period.
  • Emergency Room visits and hospitalizations.
    • Time Frame: after 3 months
    • Frequency of Emergency Room (ER) visits and hospitalizations measured over a 3 month period.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Ghent
  • Collaborator
    • University Ghent
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Guy Brusselle, M.D. , Ph.D., Principal Investigator, University Hospital, Ghent

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