Clinical trial NCT00493337: A Community Pharmacist-led Intervention to Improve Adherence to Lipid-lowering Treatment
Official title: A Community Pharmacist-led Intervention to Improve Adherence to Lipid-lowering Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: Adherence
Compliance
Statins
Intervention
Hypercholesterolemia
Lead sponsor: Utrecht Institute for Pharmaceutical Sciences
Sponsor class: OTHER
Collaborators: name: Service Apotheek BV
name: Harvard University
name: Department of Clinical Pharmacy, University Medical Centre St Radboud, The Netherlands.
name: Scientific Institute for Dutch Pharmacists, The Netherlands
name: Federation of Patients and Consumer Organisations in the Netherlands
First posted: 2007-06-28
Enrollment: 373
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility 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

Primary outcomes:
measure: The primary outcome will be mean differences in adherence over 365 days after randomization by comparing the two intervention groups with the control group.
timeFrame: one year
Secondary outcomes:
measure: Mean differences in adherence over 180 days after randomization by comparing the two intervention groups with the control group.
timeFrame: 180 days
measure: Mean differences in adherence over 270 days after randomization by comparing the two intervention groups with the control group.
timeFrame: 270 days
measure: If the pre-specified effect on mean adherence is measured, change in LDL-C will also be assessed.
timeFrame: 365 days
measure: Complete discontinuation defined as more than 182 consecutive days of the one year observation period uncovered (<50%).
timeFrame: one year
Other outcomes:
Locations:
city: Enter
country: Netherlands
facility: Service Apotheek BV
Study officials:
affiliation: Department of Pharmacoepidemiology & Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University
name: Boris LG Van Wijk, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pharmacoepidemiology & Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University
name: Anthonius De Boer, MD, PhD
role: STUDY_DIRECTOR
affiliation: Department of Pharmacoepidemiology & Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University
name: Olaf H Klungel, PharmD, PhD
role: STUDY_CHAIR
affiliation: Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston
name: William H Shrank, MD, MSHS
role: STUDY_CHAIR
affiliation: Scientific Institute of Dutch Pharmacists, The Hague
name: Peter AG De Smet, PharmD, PhD
role: STUDY_CHAIR
affiliation: Department of Pharmacoepidemiology & Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University
name: Eibert R Heerdink, PhD
role: STUDY_CHAIR
affiliation: Service Apotheek BV
name: Emma Giesen, PharmD
role: STUDY_CHAIR
affiliation: Federation of Patients and Consumer Organisations in the Netherlands, Utrecht, The Netherlands
name: Marnix Westein, PharmD
role: STUDY_CHAIR
affiliation: Scientific Institute of Dutch Pharmacists, The Hague, The Netherlands
name: Martina Teichert, PharmD
role: STUDY_CHAIR
References: