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

February 16, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Impact Of An Integrated Intervention Program On Adherence To Atorvastatin

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Springfield, Illinois, United States, 62702
        • Memorial Medical Center
      • Springfield, Illinois, United States, 62701
        • Prairie Heart Institute
      • Springfield, Illinois, United States, 62702
        • Prairie Diagnostic Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • 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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Behavioral: No Patient Counseling
Patients do not receive any adherence counseling, or other patient support services
Intervention Arm
Behavioral: Adherence Counseling
Patients receive 3-5 minutes of adherence counseling, and other patient support services

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Medication Possession Ratio (MPR)
Time Frame: 180 days
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
180 days
Percent of patients that are at least 80% adherent (PDC>0.8)
Time Frame: 180 days
180 days
Percent of patients who fill at least one atorvastatin prescription during the period of study
Time Frame: 180 days
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

February 25, 2010

First Submitted That Met QC Criteria

February 26, 2010

First Posted (Estimate)

March 2, 2010

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A2581184

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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