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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01078285
First received: February 25, 2010
Last updated: December 5, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Medication Non-Adherence
Behavioral: No Patient Counseling
Behavioral: Adherence Counseling
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Impact of an Integrated Intervention Program on Adherence to Atorvastatin

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Proportion of Days Covered (PDC) [ Time Frame: 180 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Medication Possession Ratio (MPR) [ Time Frame: 180 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Percent of patients that are at least 80% adherent (PDC>0.8) [ Time Frame: 180 days ] [ Designated as safety issue: No ]
  • Percent of patients who fill at least one atorvastatin prescription during the period of study [ Time Frame: 180 days ] [ Designated as safety issue: No ]

Enrollment: 500
Study Start Date: March 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Behavioral: No Patient Counseling
Patients do not receive any adherence counseling, or other patient support services
Active Comparator: Intervention Arm Behavioral: Adherence Counseling
Patients receive 3-5 minutes of adherence counseling, and other patient support services

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01078285

Locations
United States, Illinois
Memorial Medical Center
Springfield, Illinois, United States, 62702
Prairie Diagnostic Center
Springfield, Illinois, United States, 62702
Prairie Heart Institute
Springfield, Illinois, United States, 62701
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01078285     History of Changes
Other Study ID Numbers: A2581184
Study First Received: February 25, 2010
Last Updated: December 5, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Integrated program on adherence using counseling
support services including cost-sharing where appropriate and educational materials mailed monthly.

ClinicalTrials.gov processed this record on October 23, 2014