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

NCT ID: NCT00493337

Last Updated: 2010-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

373 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypercholesterolemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Advanced counseling

Group Type EXPERIMENTAL

advanced adherence counseling+reminder

Intervention Type BEHAVIORAL

Compliance Card only

Group Type ACTIVE_COMPARATOR

Compliance Card

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

advanced adherence counseling+reminder

Intervention Type BEHAVIORAL

Compliance Card

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Service Apotheek BV

UNKNOWN

Sponsor Role collaborator

Harvard University

OTHER

Sponsor Role collaborator

Department of Clinical Pharmacy, University Medical Centre St Radboud, The Netherlands.

OTHER

Sponsor Role collaborator

Scientific Institute for Dutch Pharmacists, The Netherlands

OTHER

Sponsor Role collaborator

Federation of Patients and Consumer Organisations in the Netherlands

UNKNOWN

Sponsor Role collaborator

Utrecht Institute for Pharmaceutical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Utrecht Institute for Pharmaceutical Sciences, Utrecht University

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Boris LG Van Wijk, PharmD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Pharmacoepidemiology & Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University

Anthonius De Boer, MD, PhD

Role: STUDY_DIRECTOR

Department of Pharmacoepidemiology & Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University

Olaf H Klungel, PharmD, PhD

Role: STUDY_CHAIR

Department of Pharmacoepidemiology & Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University

William H Shrank, MD, MSHS

Role: STUDY_CHAIR

Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston

Peter AG De Smet, PharmD, PhD

Role: STUDY_CHAIR

Scientific Institute of Dutch Pharmacists, The Hague

Eibert R Heerdink, PhD

Role: STUDY_CHAIR

Department of Pharmacoepidemiology & Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University

Emma Giesen, PharmD

Role: STUDY_CHAIR

Service Apotheek BV

Marnix Westein, PharmD

Role: STUDY_CHAIR

Federation of Patients and Consumer Organisations in the Netherlands, Utrecht, The Netherlands

Martina Teichert, PharmD

Role: STUDY_CHAIR

Scientific Institute of Dutch Pharmacists, The Hague, The Netherlands

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Service Apotheek BV

Enter, , Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NL18496.041.07

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Medicines Gaps Study
NCT05332158 UNKNOWN NA