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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
pharmaceutical care intervention
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Chronic Obstructive Pulmonary Disease, COPD

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ghent University
  • Centre Hospitalier Universitaire du Sart Tilman

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

pharmaceutical care intervention

Arm Description

Usual pharmacist care in patients with Chronic Obstructive Pulmonary Disease (COPD).

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 13, 2010
Last Updated
July 7, 2021
Sponsor
University Hospital, Ghent
Collaborators
University Ghent, GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01260389
Brief Title
Pharmaceutical Care for Chronic Obstructive Pulmonary Disease (COPD) Study.
Acronym
PHARMACOP
Official Title
Pharmaceutical Care for COPD Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
University Ghent, GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Chronic Obstructive Pulmonary Disease, COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
734 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
Usual pharmacist care in patients with Chronic Obstructive Pulmonary Disease (COPD).
Arm Title
pharmaceutical care intervention
Arm Type
Experimental
Arm Description
A pharmaceutical care intervention, focused at improving inhalation technique and drug adherence in patients with Chronic Obstructive Pulmonary Disease (COPD).
Intervention Type
Behavioral
Intervention Name(s)
pharmaceutical care intervention
Intervention Description
Pharmaceutical care intervention, focused at improving inhalation technique and drug adherence in patients with Chronic Obstructive Pulmonary Disease (COPD).
Primary Outcome Measure Information:
Title
inhalation technique baseline
Description
Inhalation technique with Chronic Obstructive Pulmonary Disease (COPD) controller medication at baseline.
Time Frame
baseline
Title
inhalation technique 1 month
Description
Inhalation technique with Chronic Obstructive Pulmonary Disease (COPD) controller medication after 1 month.
Time Frame
after 1 month
Title
inhalation technique 3 months
Description
Inhalation technique with Chronic Obstructive Pulmonary Disease (COPD) controller medication after 3 months.
Time Frame
after 3 months
Title
drug adherence
Description
Adherence to Chronic Obstructive Pulmonary Disease (COPD) controller medication after 3 months.
Time Frame
after 3 months
Secondary Outcome Measure Information:
Title
health status
Description
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.
Time Frame
baseline
Title
health status
Description
Health status, measured by: the COPD Assessment Test, MRC Dyspnoea Scale.
Time Frame
after 1 month
Title
health status
Description
Health status, measured by: the COPD Assessment Test, MRC Dyspnoea Scale and EQ-5D questionnaire.
Time Frame
after 3 months
Title
exacerbations
Description
Frequency of exacerbations measured over a 3 month period.
Time Frame
after 3 months
Title
Emergency Room visits and hospitalizations.
Description
Frequency of Emergency Room (ER) visits and hospitalizations measured over a 3 month period.
Time Frame
after 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy Brusselle, M.D., Ph.D.
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University
City
Ghent
Country
Belgium
Facility Name
Centre Hospitalier Universitaire du Sart Tilman
City
Liege
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
Related Info

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

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