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

Impact Of An Integrated Intervention Program On Adherence To Atorvastatin

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01078285
Enrollment
500
Registered
2010-03-02
Start date
2010-03-31
Completion date
2011-11-30
Last updated
2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medication Non-Adherence

Keywords

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

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.

Interventions

BEHAVIORALNo Patient Counseling

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

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

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Proportion of Days Covered (PDC)180 days

Secondary

MeasureTime frame
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 study180 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026