NCT00493337

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
373

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2007

Completed
10 months until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

June 28, 2010

Status Verified

June 1, 2007

Enrollment Period

1.8 years

First QC Date

June 27, 2007

Last Update Submit

June 24, 2010

Conditions

Hypercholesterolemia

Keywords

AdherenceComplianceStatinsInterventionHypercholesterolemia

Outcome Measures

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.

    one year

Secondary Outcomes (4)

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

    180 days

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

    270 days

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

    365 days

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

    one year

Study Arms (3)

Control group

NO INTERVENTION

Advanced counseling

EXPERIMENTAL
Behavioral: advanced adherence counseling+reminder

Compliance Card only

ACTIVE COMPARATOR
Device: Compliance Card

Interventions

advanced adherence counseling+reminderBEHAVIORAL
Advanced counseling
Compliance CardDEVICE
Compliance Card only

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Suboptimal adherent to statin treatment
  • Older than 65 years
  • Responsible for own medication intake

You may not qualify if:

  • Life expectancy shorter than 6 months
  • Institutionalized
  • User of medication blisters

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Apotheek BV

Enter, 7468 ZG, Netherlands

Location

MeSH Terms

Conditions

HypercholesterolemiaPatient Compliance

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Boris LG Van Wijk, PharmD, PhD

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

    PRINCIPAL INVESTIGATOR

  • Anthonius De Boer, MD, PhD

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

    STUDY DIRECTOR

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 27, 2007

First Posted

June 28, 2007

Study Start

May 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

June 28, 2010

Record last verified: 2007-06

Locations

NL(1)