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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 27, 2007

Last Updated Date

June 24, 2010

Start Date ^ICMJE

May 2008

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00493337 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Study Design ^ICMJE

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

Condition ^ICMJE

Hypercholesterolemia

Intervention ^ICMJE

Behavioral: advanced adherence counseling+reminder
Device: Compliance Card

Study Arm (s)

No Intervention: Control group
Experimental: Advanced counseling
Intervention: Behavioral: advanced adherence counseling+reminder
Active Comparator: Compliance Card only
Intervention: Device: Compliance Card

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

373

Completion Date

March 2010

Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

65 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT00493337

Other Study ID Numbers ^ICMJE

NL18496.041.07

Has Data Monitoring Committee

Responsible Party

BLG van WIjk, Utrecht Institute for Pharmaceutical Sciences, Utrecht University

Study Sponsor ^ICMJE

Utrecht Institute for Pharmaceutical Sciences

Collaborators ^ICMJE

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 ^ICMJE

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

Information Provided By

Utrecht Institute for Pharmaceutical Sciences

Verification Date

June 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top