HypercholesterolemiaNCT00493337
A Community Pharmacist-led Intervention to Improve Adherence to Lipid-lowering Treatment
A study testing advanced adherence counseling+reminder and Compliance Card in people with Hypercholesterolemia, run by Utrecht Institute for Pharmaceutical Sciences at 1 site in Netherlands.
Trial summary
The objective of the study is to test the effectiveness of a community pharmacist-led intervention to increase adherence to lipid lowering treatment. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- advanced adherence counseling+reminder and Compliance Card
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 373 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2008to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Suboptimal adherent to statin treatment
- Older than 65 years
- Responsible for own medication intake
Who cannot join
- Life expectancy shorter than 6 months
- Institutionalized
- User of medication blisters
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the study is to test the effectiveness of a community pharmacist-led intervention to increase adherence to lipid lowering treatment.
Read the 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.
- Conditions
- Hypercholesterolemia
- Being tested
- advanced adherence counseling+reminder, Compliance Card
- Keywords
- Adherence, Compliance, Statins, Intervention, Hypercholesterolemia
- Medical subject headings
- Hypercholesterolemia, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
advanced adherence counseling+reminderBehavioural
Compliance CardDevice
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Not described |
| Advanced counseling | Experimental | Not described Receives: Behavioral: advanced adherence counseling+reminder |
| Compliance Card only | Active comparator | Not described Receives: Device: Compliance Card |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be mean differences in adherence over 365 days after randomization by comparing the two intervention groups with the control group.
Measured: one year
Secondary outcomes (4)
Mean differences in adherence over 180 days after randomization by comparing the two intervention groups with the control group.
Measured: 180 days
Mean differences in adherence over 270 days after randomization by comparing the two intervention groups with the control group.
Measured: 270 days
If the pre-specified effect on mean adherence is measured, change in LDL-C will also be assessed.
Measured: 365 days
Complete discontinuation defined as more than 182 consecutive days of the one year observation period uncovered (<50%).
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2007 (estimated)
- Study startMay 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- Utrecht Institute for Pharmaceutical Sciences
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Boris LG Van Wijk, PharmD, PhD, Principal investigator, Department of Pharmacoepidemiology & Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht UniversityAnthonius De Boer, MD, PhD, Study director, Department of Pharmacoepidemiology & Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht UniversityOlaf H Klungel, PharmD, PhD, Study chair, Department of Pharmacoepidemiology & Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht UniversityWilliam H Shrank, MD, MSHS, Study chair, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, BostonPeter AG De Smet, PharmD, PhD, Study chair, Scientific Institute of Dutch Pharmacists, The HagueEibert R Heerdink, PhD, Study chair, Department of Pharmacoepidemiology & Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht UniversityEmma Giesen, PharmD, Study chair, Service Apotheek BVMarnix Westein, PharmD, Study chair, Federation of Patients and Consumer Organisations in the Netherlands, Utrecht, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00493337
- Sponsor's protocol ID
- NL18496.041.07
- Status last verified
- Jun 2007
- First submitted
- 27 Jun 2007
- Last updated
- 28 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community Pharmacist-led Intervention to Improve Adherence to Lipid-lowering Treatment
- ClinicalTrials.gov ID
- NCT00493337
- Acronym / sponsor ID
- NL18496.041.07
- Conditions
- Hypercholesterolemia
- Keywords
- Adherence, Compliance, Statins, Intervention, Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- Utrecht Institute for Pharmaceutical SciencesUniversity, hospital or other
- 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
- Study start
- May 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 28 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | – |
| Advanced counseling | Experimental | Behavioral: advanced adherence counseling+reminder |
| Compliance Card only | Active comparator | Device: Compliance Card |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Suboptimal adherent to statin treatment
- Older than 65 years
- Responsible for own medication intake
Key exclusion criteria (3 listed)
- Life expectancy shorter than 6 months
- Institutionalized
- User of medication blisters
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| advanced adherence counseling+reminder | Behavioural | Advanced counseling |
| Compliance Card | Device | Compliance Card only |
Primary outcome
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
4 secondary outcomes
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
Complete discontinuation defined as more than 182 consecutive days of the one year observation period uncovered (<50%).
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boris LG Van Wijk, PharmD, PhD principal investigator
Department of Pharmacoepidemiology & Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University
Anthonius De Boer, MD, PhD study director
Department of Pharmacoepidemiology & Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University
Olaf H Klungel, PharmD, PhD study chair
Department of Pharmacoepidemiology & Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing advanced adherence counseling+reminder and Compliance Card in people with Hypercholesterolemia, run by Utrecht Institute for Pharmaceutical Sciences at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2010.