Statin Therapy to Improve Medication Adherence

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01894217
First received: July 3, 2013
Last updated: January 3, 2014
Last verified: July 2013
  Purpose

The purpose of this pilot study is to examine if using genetics can improve statin adherence in patients who should be taking statins but are not because of prior side effects with statins. This study will assist physicians in making a personalized health care plan for prevention of cardiovascular disease.


Condition Intervention Phase
Hypercholesterolemia
HMG COA Reductase Inhibitor Adverse Reaction
Genetic: Genetic testing and reporting for SLCO1B1*5 allele
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pilot Study: Statin Therapy to Improve Medication Adherence

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in Beliefs about Medicines [ Time Frame: Baseline and four months post genetic testing ] [ Designated as safety issue: No ]
    The Beliefs about Medicines Questionnaire (BMQ) is a validated tool and assesses patients' beliefs about their medications. Specifically, the BMQ assesses patients' perceived necessity for the prescribed medication to treat their disease as well as their concerns about adverse effects of the medication. The BMQ-specific survey will be employed as applied to 1) cholesterol lowering therapy and 2) medication therapy in general. Each question is answered with a 5-point Likert scale, ranging from 1 = strongly disagree to 5 = strongly agree. Scores obtained for individual items within the Concerns or Necessities scales are summed and total scores range from 5 to 25 (higher scores indicate stronger beliefs). Perceived concerns associated with drugs have been found to be significant predictors of poorer medication adherence.

  • Change in Medication adherence [ Time Frame: baseline and four month post genotyping ] [ Designated as safety issue: No ]
    Medication adherence is assessed by the 8-item Morisky medication adherence scale (MMAS). The first 7 questions of the MMAS are scored one point for 'yes' and zero points for a 'no' response; the last question is assessed using a 5-point Likert-type responses ranging from "usually" to "all the time" (usually = 1; all the time = 5). Non-adherence is defined as a score higher than zero. For the purposes of this pilot study, the MMAS is adapted to focus on cholesterol lowering therapies.


Secondary Outcome Measures:
  • Percentage of patients who meets their National Cholesterol Education Program (NCEP) low-density lipoprotein cholesterol (LDLc)goals [ Time Frame: Four months ] [ Designated as safety issue: No ]
    Patients who received the genetically-guided intervention will be compared to matched historical controls (2:1) and concurrent controls (2:1)

  • Number of new statin prescriptions written [ Time Frame: Four months ] [ Designated as safety issue: No ]
    Patients who received the genetically-guided intervention will be compared to matched historical controls (2:1) and concurrent controls (2:1)

  • Patient reported medication utilization, as a surrogate for medication adherence [ Time Frame: Four months ] [ Designated as safety issue: No ]
    Patients who received the genetically-guided intervention will be compared to matched historical controls (2:1) and concurrent controls (2:1)


Enrollment: 63
Study Start Date: May 2011
Estimated Study Completion Date: May 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Genetic testing
Genetic testing and reporting for SLCO1B1*5 allele
Genetic: Genetic testing and reporting for SLCO1B1*5 allele
Blood test for SLCO1B1*5 allele; reporting of test results to provider and participant

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current patient (defined as seen in the last year) of the Duke Primary Care at Pickett Road or Center for Living
  • Age greater than or equal to 18 years
  • Provider interested in prescribing statins for cardiovascular disease prevention
  • Ability to provide informed consent

Exclusion Criteria:

  • Prior rhabdomyolysis, defined as CK elevation > 10 times the upper limit of normal with any statin therapy
  • Prior unexplained elevation in hepatic enzymes (AST or ALT > 3 times upper limit of normal) with any statin therapy
  • Use of medications known to interfere with statin metabolism or disposition
  • Participation in a drug research study in the past 30 days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01894217

Locations
United States, North Carolina
Duke Primary Care Clinic at Pickett Road
Durham, North Carolina, United States, 27705
Duke Center for Living
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Deepak Voora, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01894217     History of Changes
Other Study ID Numbers: Pro00029836
Study First Received: July 3, 2013
Last Updated: January 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
high cholesterol
genetic testing
medication adherence
statins
Adverse Effects
Pharmacogenetic

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014