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| Name | Class |
|---|---|
| Service Apotheek BV | UNKNOWN |
| Harvard University | OTHER |
| Department of Clinical Pharmacy, University Medical Centre St Radboud, The Netherlands. | OTHER |
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The objective of the study is to test the effectiveness of a community pharmacist-led intervention to increase adherence to lipid lowering treatment.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | ||
| Advanced counseling | Experimental |
| |
| Compliance Card only | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| advanced adherence counseling+reminder | Behavioral |
| ||
| Compliance Card |
| Measure | Description | 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. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Mean differences in adherence over 180 days after randomization by comparing the two intervention groups with the control group. | 180 days | |
| Mean differences in adherence over 270 days after randomization by comparing the two intervention groups with the control group. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boris LG Van Wijk, PharmD, PhD | Department of Pharmacoepidemiology & Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University | Principal Investigator |
| Anthonius De Boer, MD, PhD | Department of Pharmacoepidemiology & Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University | Study Director |
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service Apotheek BV | Enter | 7468 ZG | Netherlands |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| Scientific Institute for Dutch Pharmacists, The Netherlands |
| OTHER |
| Federation of Patients and Consumer Organisations in the Netherlands | UNKNOWN |
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| Device |
|
| 270 days |
| If the pre-specified effect on mean adherence is measured, change in LDL-C will also be assessed. | 365 days |
| Complete discontinuation defined as more than 182 consecutive days of the one year observation period uncovered (<50%). | one year |
| Study Chair |
| Martina Teichert, PharmD | Scientific Institute of Dutch Pharmacists, The Hague, The Netherlands | Study Chair |
| D009750 |
| Nutritional and Metabolic Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |