A Community Pharmacist-led Intervention to Improve Adherence to Lipid-lowering Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Community Pharmacist-led Intervention to Improve Adherence to Lipid-lowering Treatment

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Behavioral: advanced adherence counseling+reminder
* Device: Compliance Card


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br> | |
| Experimental: Advanced counseling<br> | Behavioral: advanced adherence counseling+reminder<br> <br> |
| Active Comparator: Compliance Card only<br> | Device: Compliance Card<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adherence, Compliance, Statins, Intervention, Hypercholesterolemia