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

Not Applicable

Completed

• Conditions: Hypercholesterolemia
• Interventions: Behavioral: advanced adherence counseling+reminder; Device: Compliance Card

• Registration Number: NCT00493337
• Lead Sponsor: Utrecht Institute for Pharmaceutical Sciences

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.

Study Timeline

• Status Verified: 2007-06
• Study First Submitted: 2007-06-27
• Study First Submitted QC: 2007-06-27
• Study First Posted: 2007-06-28
• Study Start: 2008-05
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Last Update Submitted: 2010-06-24
• Last Update Posted: 2010-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 373

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Advanced counseling	advanced adherence counseling+reminder	-
Compliance Card only	Compliance Card	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Service Apotheek BV; 🇳🇱 Enter, Netherlands