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

This study has been completed.
Sponsor:
Collaborators:
Service Apotheek BV
Harvard University
Department of Clinical Pharmacy, University Medical Centre St Radboud, The Netherlands.
Scientific Institute for 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
First received: June 27, 2007
Last updated: June 24, 2010
Last verified: June 2007
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Community Pharmacist-led Intervention to Improve Adherence to Lipid-lowering Treatment

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Mean differences in adherence over 270 days after randomization by comparing the two intervention groups with the control group. [ Time Frame: 270 days ] [ Designated as safety issue: No ]
  • If the pre-specified effect on mean adherence is measured, change in LDL-C will also be assessed. [ Time Frame: 365 days ] [ Designated as safety issue: No ]
  • Complete discontinuation defined as more than 182 consecutive days of the one year observation period uncovered (<50%). [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 373
Study Start Date: May 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
Experimental: Advanced counseling Behavioral: advanced adherence counseling+reminder
Active Comparator: Compliance Card only 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 for 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

No publications provided

Responsible Party: BLG van WIjk, Utrecht Institute for Pharmaceutical Sciences, Utrecht University
ClinicalTrials.gov Identifier: NCT00493337     History of Changes
Other Study ID Numbers: NL18496.041.07
Study First Received: June 27, 2007
Last Updated: June 24, 2010
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 20, 2014