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A Community Pharmacist-Led Intervention to Improve Adherence to Lipid-Lowering Treatment
This study is not yet open for participant recruitment.
Verified by Utrecht Institute for Pharmaceutical Sciences, June 2007
Sponsors and Collaborators: Utrecht Institute for Pharmaceutical Sciences
Service Apotheek BV
Harvard University
Department of Clinical Pharmacy, University Medical Centre St Radboud, The Netherlands.
Scientific Institute of Dutch Pharmacists, The Netherlands
Federation of Patients and Consumer Organisations in the Netherlands
Information provided by: Utrecht Institute for Pharmaceutical Sciences
ClinicalTrials.gov Identifier: NCT00493337
  Purpose

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


Condition Intervention
Hypercholesterolemia
Behavioral: advanced adherence counseling+reminder
Device: Compliance Card

Genetics Home Reference related topics: hypercholesterolemia
MedlinePlus related topics: Cholesterol
Drug Information available for: Lipids
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: A Community Pharmacist-Led Intervention to Improve Adherence to Lipid-Lowering Treatment

Further study details as provided by Utrecht Institute for Pharmaceutical Sciences:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Mean differences in adherence over 180 days after randomization by comparing the two intervention groups with the control group. [ Time Frame: 180 days ]
  • Mean differences in adherence over 270 days after randomization by comparing the two intervention groups with the control group. [ Time Frame: 270 days ]
  • If the pre-specified effect on mean adherence is measured, change in LDL-C will also be assessed. [ Time Frame: 365 days ]
  • Complete discontinuation defined as more than 182 consecutive days of the one year observation period uncovered (<50%). [ Time Frame: one year ]

Estimated Enrollment: 300
Study Start Date: April 2008
Estimated Study Completion Date: July 2009
Arms Assigned Interventions
Control group: No Intervention
Advanced counseling: Experimental Behavioral: advanced adherence counseling+reminder
Compliance Card only: Active Comparator Device: Compliance Card

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.

  Eligibility

Ages Eligible for Study:   65 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00493337

Contacts
Contact: Boris LG Van WIjk, PharmD +31 30 253 7324 b.l.g.vanwijk@uu.nl

Locations
Netherlands
Service Apotheek BV
Enter, Netherlands, 7468 ZG
Sponsors and Collaborators
Utrecht Institute for Pharmaceutical Sciences
Service Apotheek BV
Harvard University
Department of Clinical Pharmacy, University Medical Centre St Radboud, The Netherlands.
Scientific Institute of Dutch Pharmacists, The Netherlands
Federation of Patients and Consumer Organisations in the Netherlands
Investigators
Principal Investigator: Boris LG Van Wijk, PharmD, PhD Department of Pharmacoepidemiology & Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University
Study Director: Anthonius De Boer, MD, PhD Department of Pharmacoepidemiology & Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University
Study Chair: Olaf H Klungel, PharmD, PhD Department of Pharmacoepidemiology & Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University
Study Chair: William H Shrank, MD, MSHS Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston
Study Chair: Peter AG De Smet, PharmD, PhD Scientific Institute of Dutch Pharmacists, The Hague
Study Chair: Eibert R Heerdink, PhD Department of Pharmacoepidemiology & Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University
Study Chair: Emma Giesen, PharmD Service Apotheek BV
Study Chair: Marnix Westein, PharmD Federation of Patients and Consumer Organisations in the Netherlands, Utrecht, The Netherlands
Study Chair: Martina Teichert, PharmD Scientific Institute of Dutch Pharmacists, The Hague, The Netherlands
  More Information

Study ID Numbers: NL18496.041.07
Study First Received: June 27, 2007
Last Updated: November 19, 2008
ClinicalTrials.gov Identifier: NCT00493337  
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Utrecht Institute for Pharmaceutical Sciences:
Adherence
Compliance
Statins
Intervention
Hypercholesterolemia

Study placed in the following topic categories:
Metabolic Diseases
Hyperlipidemias
Metabolic disorder
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009