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Community Pharmacy Assisting in Total Cardiovascular Health (CPATCH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01509014
Recruitment Status : Unknown
Verified January 2012 by University of Saskatchewan.
Recruitment status was:  Active, not recruiting
First Posted : January 12, 2012
Last Update Posted : January 12, 2012
Saskatchewan Ministry of Health
Merck Frosst Canada Ltd.
Information provided by (Responsible Party):
University of Saskatchewan

Brief 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.

The purpose of this study is to determine whether a simple intervention by community pharmacists can improve statin adherence in new statin users.

Condition or disease Intervention/treatment
Statin Therapy Adherence Behavioral: CPATCH intervention to support statin adherence

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Study Start Date : March 2010
Primary Completion Date : November 2011
Estimated Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Pharmacy Intervention Arm
All patients receiving statins from pharmacies allocated to the pharmacist intervention arm of the study
Behavioral: CPATCH intervention to support statin adherence
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.
No Intervention: Usual Care
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.

Primary Outcome Measures :
  1. 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.,

Secondary Outcome Measures :
  1. Proportion of new statin users with adherence greater than or equal to 80% [ Time Frame: 6 months ]
  2. Persistence with statin use among patients with a minimum of 12 months of follow-up [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509014

Canada, Saskatchewan
College of Pharmacy and Nutrition, University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7n 5C9
Sponsors and Collaborators
University of Saskatchewan
Saskatchewan Ministry of Health
Merck Frosst Canada Ltd.

Responsible Party: University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01509014     History of Changes
Obsolete Identifiers: NCT00971412
First Posted: January 12, 2012    Key Record Dates
Last Update Posted: January 12, 2012
Last Verified: January 2012

Keywords provided by University of Saskatchewan:

Additional relevant MeSH terms:
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents