A Community Pharmacist-led Intervention to Improve Adherence to Lipid-lowering Treatment
June 24, 2010 updated by: Utrecht Institute for Pharmaceutical Sciences
The objective of the study is to test the effectiveness of a community pharmacist-led intervention to increase adherence to lipid lowering treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Medication non-adherence represents an important threat to the health of the Western people.
A large number of pharmacy records based studies demonstrated that adherence to lipid lowering treatment in daily practice is substantially worse compared to adherence observed in the controlled setting of randomized controlled trials.
In addition, the relationship between non-adherence with statin-treatment assessed with pharmacy records and cardiovascular outcomes has been convincingly demonstrated.
This implies that pharmacy records can and should be used to identify non-adherent patients and thus patients at risk for major cardiovascular events.
Using this data, community pharmacists can play a more substantive role in developing the concept of pharmaceutical care.
The objective of the study is to test the effectiveness of a community pharmacist-led intervention to increase adherence to lipid lowering treatment.
Study Type
Interventional
Enrollment (Actual)
373
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Enter, Netherlands, 7468 ZG
- Service Apotheek BV
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 90 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Suboptimal adherent to statin treatment
- Older than 65 years
- Responsible for own medication intake
Exclusion Criteria:
- Life expectancy shorter than 6 months
- Institutionalized
- User of medication blisters
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control group
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Experimental: Advanced counseling
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Active Comparator: Compliance Card only
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The primary outcome will be mean differences in adherence over 365 days after randomization by comparing the two intervention groups with the control group.
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mean differences in adherence over 180 days after randomization by comparing the two intervention groups with the control group.
Time Frame: 180 days
|
180 days
|
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Mean differences in adherence over 270 days after randomization by comparing the two intervention groups with the control group.
Time Frame: 270 days
|
270 days
|
|
If the pre-specified effect on mean adherence is measured, change in LDL-C will also be assessed.
Time Frame: 365 days
|
365 days
|
|
Complete discontinuation defined as more than 182 consecutive days of the one year observation period uncovered (<50%).
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Boris LG Van Wijk, PharmD, PhD, Department of Pharmacoepidemiology & Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University
- Study Director: Anthonius De Boer, MD, PhD, Department of Pharmacoepidemiology & Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University
- Study Chair: Olaf H Klungel, PharmD, PhD, Department of Pharmacoepidemiology & Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University
- Study Chair: William H Shrank, MD, MSHS, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston
- Study Chair: Peter AG De Smet, PharmD, PhD, Scientific Institute of Dutch Pharmacists, The Hague
- Study Chair: Eibert R Heerdink, PhD, Department of Pharmacoepidemiology & Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University
- Study Chair: Emma Giesen, PharmD, Service Apotheek BV
- Study Chair: Marnix Westein, PharmD, Federation of Patients and Consumer Organisations in the Netherlands, Utrecht, The Netherlands
- Study Chair: Martina Teichert, PharmD, Scientific Institute of Dutch Pharmacists, The Hague, The Netherlands
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
June 27, 2007
First Submitted That Met QC Criteria
June 27, 2007
First Posted (Estimate)
June 28, 2007
Study Record Updates
Last Update Posted (Estimate)
June 28, 2010
Last Update Submitted That Met QC Criteria
June 24, 2010
Last Verified
June 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL18496.041.07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.