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

Completed

• Conditions: Medication Non-Adherence
• Interventions: Behavioral: Adherence Counseling; Behavioral: No Patient Counseling

• Registration Number: NCT01078285
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-25
• Study First Submitted QC: 2010-02-26
• Study Start: 2010-03
• Study First Posted: 2010-03-02
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Adherence Counseling	-
Control	No Patient Counseling	-

Primary Outcome Measures

Name	Time	Method
Proportion of Days Covered (PDC)	180 days

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Memorial Medical Center; 🇺🇸 Springfield, Illinois, United States

Prairie Heart Institute; 🇺🇸 Springfield, Illinois, United States

Prairie Diagnostic Center; 🇺🇸 Springfield, Illinois, United States