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

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00493337
• Other study ID #: NL18496.041.07
• Status: Completed
• Phase: N/A
• First received: June 27, 2007
• Last updated: June 24, 2010
• Start date: May 2008
• Est. completion date: March 2010

Study information

• Verified date: June 2007
• Source: Utrecht Institute for Pharmaceutical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to test the effectiveness of a community pharmacist-led intervention to increase adherence to lipid lowering treatment.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 373
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Behavioral:
• advanced adherence counseling+reminder

Device:
• Compliance Card

Locations

Country	Name	City	State
Netherlands	Service Apotheek BV	Enter

Sponsors (6)

Lead Sponsor	Collaborator
Utrecht Institute for Pharmaceutical Sciences	Department of Clinical Pharmacy, University Medical Centre St Radboud, The Netherlands., Federation of Patients and Consumer Organisations in the Netherlands, Harvard University, Scientific Institute for Dutch Pharmacists, The Netherlands, Service Apotheek BV

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mean differences in adherence over 180 days after randomization by comparing the two intervention groups with the control group.		180 days	No
Secondary	Mean differences in adherence over 270 days after randomization by comparing the two intervention groups with the control group.		270 days	No
Secondary	If the pre-specified effect on mean adherence is measured, change in LDL-C will also be assessed.		365 days	No
Secondary	Complete discontinuation defined as more than 182 consecutive days of the one year observation period uncovered (<50%).		one year	No