Hypercholesterolemia
Conditions
Keywords
Adherence, Compliance, Statins, Intervention, Hypercholesterolemia
Brief summary
The objective of the study is to test the effectiveness of a community pharmacist-led intervention to increase adherence to lipid lowering 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.
Interventions
BEHAVIORALadvanced adherence counseling+reminder
DEVICECompliance Card
Sponsors
Service Apotheek BV
Harvard University
Department of Clinical Pharmacy, University Medical Centre St Radboud, The Netherlands.
Scientific Institute for Dutch Pharmacists, The Netherlands
Federation of Patients and Consumer Organisations in the Netherlands
Utrecht Institute for Pharmaceutical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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. | one year |
Secondary
| Measure | 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. | 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 |
Countries
Netherlands
Outcome results
None listed