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

Medication Non-Adherence Clinical Trial

Official title:

Impact Of An Integrated Intervention Program On Adherence To Atorvastatin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01078285
• Other study ID #: A2581184
• Status: Completed
• Start date: March 2010
• Est. completion date: November 2011

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Medication Non-Adherence

Intervention

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

Locations

Country	Name	City	State
United States	Memorial Medical Center	Springfield	Illinois
United States	Prairie Diagnostic Center	Springfield	Illinois
United States	Prairie Heart Institute	Springfield	Illinois

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Days Covered (PDC)		180 days
Secondary	Medication Possession Ratio (MPR)		180 days
Secondary	Persistence-the number of continuous days a patient is supplied with medication using the allowable grace period or gap (30 or 60 days).		180 days
Secondary	Percent of patients that are at least 80% adherent (PDC>0.8)		180 days
Secondary	Percent of patients who fill at least one atorvastatin prescription during the period of study		180 days

External Links

•   To obtain contact information for a study center near you, click here.