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Completed

NCT Number: NCT00493337

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

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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Key information

Conditions

Hypercholesterolemia Behavior Dyslipidemias Health Behavior Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service Apotheek BV

Enter, 7468 ZG, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

advanced adherence counseling+reminder

Behavioral

Compliance Card

Device

Primary outcomes

  1. The primary outcome will be mean differences in adherence over 365 days after randomization by comparing the two intervention groups with the control group.

    Time frame: one year

Secondary outcomes

  1. Mean differences in adherence over 180 days after randomization by comparing the two intervention groups with the control group.

    Time frame: 180 days

  2. Mean differences in adherence over 270 days after randomization by comparing the two intervention groups with the control group.

    Time frame: 270 days

  3. If the pre-specified effect on mean adherence is measured, change in LDL-C will also be assessed.

    Time frame: 365 days

  4. Complete discontinuation defined as more than 182 consecutive days of the one year observation period uncovered (<50%).

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Utrecht Institute for Pharmaceutical Sciences

Other

Collaborators

  • 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

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 28, 2007
Registry last updated
Jun 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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