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Sponsors and Collaborators: |
Utrecht Institute for Pharmaceutical Sciences Service Apotheek BV Harvard University Department of Clinical Pharmacy, University Medical Centre St Radboud, The Netherlands. Scientific Institute of Dutch Pharmacists, The Netherlands Federation of Patients and Consumer Organisations in the Netherlands |
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Information provided by: | Utrecht Institute for Pharmaceutical Sciences |
ClinicalTrials.gov Identifier: | NCT00493337 |
The objective of the study is to test the effectiveness of a community pharmacist-led intervention to increase adherence to lipid lowering treatment.
Condition | Intervention |
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Hypercholesterolemia |
Behavioral: advanced adherence counseling+reminder Device: Compliance Card |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Community Pharmacist-Led Intervention to Improve Adherence to Lipid-Lowering Treatment |
Estimated Enrollment: | 300 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | July 2009 |
Arms | Assigned Interventions |
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Control group: No Intervention | |
Advanced counseling: Experimental | Behavioral: advanced adherence counseling+reminder |
Compliance Card only: Active Comparator | Device: Compliance Card |
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.
Ages Eligible for Study: | 65 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Boris LG Van WIjk, PharmD | +31 30 253 7324 | b.l.g.vanwijk@uu.nl |
Netherlands | |
Service Apotheek BV | |
Enter, Netherlands, 7468 ZG |
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 ID Numbers: | NL18496.041.07 |
Study First Received: | June 27, 2007 |
Last Updated: | November 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00493337 |
Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Adherence Compliance Statins Intervention Hypercholesterolemia |
Metabolic Diseases Hyperlipidemias Metabolic disorder |
Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |