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OpenTrials
Completed

NCT Number: NCT01078285

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

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.

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Key information

Conditions

Medication Non-adherence Behavior Health Behavior Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Medical Center, Springfield, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No Patient Counseling

Behavioral

Patients do not receive any adherence counseling, or other patient support services

Adherence counseling

Behavioral

Patients receive 3-5 minutes of adherence counseling, and other patient support services

Primary outcomes

  1. Proportion of Days Covered (PDC)

    Time frame: 180 days

Secondary outcomes

  1. Medication Possession Ratio (MPR)

    Time frame: 180 days

  2. 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

  3. Percent of patients that are at least 80% adherent (PDC>0.8)

    Time frame: 180 days

  4. Percent of patients who fill at least one atorvastatin prescription during the period of study

    Time frame: 180 days

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

Impact Of An Integrated Intervention Program On Adherence To Atorvastatin

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 2, 2010
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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