NCT01078285

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2010

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

1.7 years

First QC Date

February 25, 2010

Last Update Submit

February 16, 2021

Conditions

Keywords

Integrated program on adherence using counselingsupport services including cost-sharing where appropriate and educational materials mailed monthly.

Outcome Measures

Primary Outcomes (1)

  • Proportion of Days Covered (PDC)

    180 days

Secondary Outcomes (4)

  • Medication Possession Ratio (MPR)

    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

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

    180 days

Study Arms (2)

Control

Behavioral: No Patient Counseling

Intervention Arm

Behavioral: Adherence Counseling

Interventions

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

Control

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

Intervention Arm

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Prairie Heart Institute

Springfield, Illinois, 62701, United States

Location

Memorial Medical Center

Springfield, Illinois, 62702, United States

Location

Prairie Diagnostic Center

Springfield, Illinois, 62702, United States

Location

Related Links

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2010

First Posted

March 2, 2010

Study Start

March 1, 2010

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

February 18, 2021

Record last verified: 2021-02

Locations