Statin Therapy to Improve Medication Adherence

NCT01894217 | Completed Phase 1

• 1 other identifier: Pro00029836
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hypercholesterolemia; HMG COA Reductase Inhibitor Adverse Reaction

Keywords

high cholesterol; genetic testing; medication adherence; statins; Adverse Effects; Pharmacogenetic

Outcome Measures

Primary Outcomes (2)

• Change in Beliefs about Medicines

  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.

  Baseline and four months post genetic testing

• Change in Medication adherence

  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.

  baseline and four month post genotyping

Secondary Outcomes (3)

• Percentage of patients who meets their National Cholesterol Education Program (NCEP) low-density lipoprotein cholesterol (LDLc)goals

  Four months

• Number of new statin prescriptions written

  Four months

• Patient reported medication utilization, as a surrogate for medication adherence

  Four months

Study Arms (1)

Genetic testing

EXPERIMENTAL

Genetic testing and reporting for SLCO1B1\*5 allele

Genetic: Genetic testing and reporting for SLCO1B1*5 allele

Interventions

Genetic testing and reporting for SLCO1B1*5 allele GENETIC

Blood test for SLCO1B1\*5 allele; reporting of test results to provider and participant

Genetic testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (2)

Duke Center for Living

Durham, North Carolina, 27705, United States

Location

Duke Primary Care Clinic at Pickett Road

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia; Medication Adherence

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Deepak Voora, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: July 10, 2013
• Study Start: May 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2014
• Last Updated: January 8, 2015

Record last verified: 2015-01

Locations

US (2)