Effectiveness Of A Program That Includes Counseling And Patient Support On Adherence To Treatment With Lipitor

Overview

Despite extensive reports of the benefits of statins in reducing serious cardiovascular events such as stroke and heart disease in patients with elevated LDL-cholesterol, patients do not take their medicines regularly as prescribed. Reasons include forgetfulness, lack of understanding of the seriousness of the disease, and fear of side effects. An intervention strategy comprising 3-5 minutes of counseling, emotional support and cost-sharing may be motivational and improve adherence to treatment.

Full Title of Study: “Impact Of An Integrated Intervention Program On Adherence To Atorvastatin”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2011

Interventions

  • Behavioral: No Patient Counseling
    • Patients do not receive any adherence counseling, or other patient support services
  • Behavioral: Adherence Counseling
    • Patients receive 3-5 minutes of adherence counseling, and other patient support services

Arms, Groups and Cohorts

  • Control
  • Intervention Arm

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of Days Covered (PDC)
    • Time Frame: 180 days

Secondary Measures

  • Medication Possession Ratio (MPR)
    • Time Frame: 180 days
  • Persistence-the number of continuous days a patient is supplied with medication using the allowable grace period or gap (30 or 60 days).
    • Time Frame: 180 days
  • Percent of patients that are at least 80% adherent (PDC>0.8)
    • Time Frame: 180 days
  • Percent of patients who fill at least one atorvastatin prescription during the period of study
    • Time Frame: 180 days

Participating in This Clinical Trial

Inclusion Criteria

  • Male and female aged >21 years
  • Have received a new or re-fil prescription for atorvastatin at first study visit to Prairie Heart Institute
  • Signed informed consent

Exclusion Criteria

  • Unwilling to give written informed consent
  • Failed statin treatment in the past
  • Switched from another statin to atorvastatin because of co-pay program
  • Participated in an earlier Market Research study on Impact of cholesterol management behaviors post in-clinic adherence intervention

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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