Statin TherapyCPATCHNCT01509014
Community Pharmacy Assisting in Total Cardiovascular Health
A study testing CPATCH intervention to support statin adherence in people with Statin Therapy and Adherence, run by University of Saskatchewan at 1 site in Canada.
Trial summary
Despite proven benefits in reducing morbidity and mortality, many patients become nonadherent to statin therapy within the first year of starting. Due to their accessibility and frequent patient contact, pharmacists are well-positioned to improve medication adherence. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Statin Therapy, Adherence
- What is being tested?
- CPATCH intervention to support statin adherence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,250 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2010to Jan 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pharmacies must fill at least 85 statin prescriptions in a six-week period
- CPATCH intervention was given priority over other study initiatives offered by the pharmacy
- All members of pharmacy staff provided informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site
College of Pharmacy and Nutrition, University of Saskatchewan
Saskatoon, Saskatchewan, S7n 5C9
About this study
Despite proven benefits in reducing morbidity and mortality, many patients become nonadherent to statin therapy within the first year of starting. Due to their accessibility and frequent patient contact, pharmacists are well-positioned to improve medication adherence.
The purpose of this study is to determine whether a simple intervention by community pharmacists can improve statin adherence in new statin users.
- Conditions
- Statin Therapy, Adherence
- Being tested
- CPATCH intervention to support statin adherence
- Keywords
- Statins, Adherence, Pharmacists
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPATCH intervention to support statin adherenceBehavioural
Routine identification of new statin users (first year of therapy), consistent assessment of barriers to adherence at every dispensation for these patients, reassurance about efficacy and safety, and proactive response to identified adherence barriers.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacy Intervention Arm | Experimental | All patients receiving statins from pharmacies allocated to the pharmacist intervention arm of the study Receives: Behavioral: CPATCH intervention to support statin adherence |
| Usual Care | No intervention | Pharmacies not allocated to the intervention arm will serve as the control. They received no training on the CPATCH intervention and provide usual care to patients at their pharmacy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean statin adherence among all eligible new users of statin medications with at least 6 months of follow-up from index prescription
All statin dispensations are captured by the prescription drug plan database. Mean adherence will be measured using the proportion of days covered (sum of days supply for statin prescriptions during study period divided by the number of days of observation). PDC will be adjusted for any days subject was hospitalized during study period.,
Measured: 6 months
Secondary outcomes (2)
Proportion of new statin users with adherence greater than or equal to 80%
Measured: 6 months
Persistence with statin use among patients with a minimum of 12 months of follow-up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startMar 2010
- Primary completionNov 2011
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Statin TherapyStudies 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Saskatchewan, Merck Frosst Canada Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509014
- Sponsor's protocol ID
- NCT00971412
- Acronym
- CPATCH
- Status last verified
- Jan 2012
- First submitted
- 9 Jan 2012
- Last updated
- 12 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Evans CD, Eurich DT, Taylor JG, Remillard AJ, Shevchuk YM, Blackburn DF. A pragmatic cluster randomized trial evaluating the impact of a community pharmacy intervention on statin adherence: rationale and design of the Community Pharmacy Assisting in Total Cardiovascular Health (CPATCH) study. Trials. 2010 Jul 8;11:76. doi: 10.1186/1745-6215-11-76.
PubMed 20615235
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Pharmacy Assisting in Total Cardiovascular Health
- ClinicalTrials.gov ID
- NCT01509014
- Acronym / sponsor ID
- CPATCH / NCT00971412
- Conditions
- Statin Therapy, Adherence
- Keywords
- Statins, Adherence, Pharmacists
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,250 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Ministry of Health, Saskatchewan, Merck Frosst Canada Ltd.
- Study start
- Mar 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jan 2012 (estimated)
- First posted
- 12 Jan 2012 (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.
Despite proven benefits in reducing morbidity and mortality, many patients become nonadherent to statin therapy within the first year of starting. Due to their accessibility and frequent patient contact, pharmacists are well-positioned to improve medication adherence.
The purpose of this study is to determine whether a simple intervention by community pharmacists can improve statin adherence in new statin users.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacy Intervention Arm | Experimental | Behavioral: CPATCH intervention to support statin adherenceAll patients receiving statins from pharmacies allocated to the pharmacist intervention arm of the study |
| Usual Care | No intervention | –Pharmacies not allocated to the intervention arm will serve as the control. They received no training on the CPATCH intervention and provide usual care to patients at their pharmacy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Pharmacies must fill at least 85 statin prescriptions in a six-week period
- CPATCH intervention was given priority over other study initiatives offered by the pharmacy
- All members of pharmacy staff provided informed consent
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| CPATCH intervention to support statin adherenceRoutine identification of new statin users (first year of therapy), consistent assessment of barriers to adherence at every dispensation for these patients, reassurance about efficacy and safety, and proactive response to identified adherence barriers. | Behavioural | Pharmacy Intervention Arm |
Primary outcome
Mean statin adherence among all eligible new users of statin medications with at least 6 months of follow-up from index prescription
Time frame: 6 months
All statin dispensations are captured by the prescription drug plan database. Mean adherence will be measured using the proportion of days covered (sum of days supply for statin prescriptions during study period divided by the number of days of observation). PDC will be adjusted for any days subject was hospitalized during study period.,
2 secondary outcomes
Proportion of new statin users with adherence greater than or equal to 80%
Time frame: 6 months
Persistence with statin use among patients with a minimum of 12 months of follow-up
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2012.
- Background: PubMed 20615235Evans CD, Eurich DT, Taylor JG, Remillard AJ, Shevchuk YM, Blackburn DF. A pragmatic cluster randomized trial evaluating the impact of a community pharmacy intervention on statin adherence: rationale and design of the Community Pharmacy Assisting in Total Cardiovascular Health (CPATCH) study. Trials. 2010 Jul 8;11:76. doi: 10.1186/1745-6215-11-76.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPATCH intervention to support statin adherence in people with Statin Therapy and Adherence, run by University of Saskatchewan at 1 site in Canada.
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 0 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: status not confirmed, as of the sponsor's last update on 12 Jan 2012. 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 Canada. 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?
Results are not available in the source record.
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?
Mean statin adherence among all eligible new users of statin medications with at least 6 months of follow-up from index prescription (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01509014, which also lists 1 linked publication.
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 12 Jan 2012.