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

NCT ID: NCT01078285

Last Updated: 2021-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Medication Non-Adherence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

No Patient Counseling

Intervention Type BEHAVIORAL

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

Intervention Arm

Adherence Counseling

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No Patient Counseling

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

Intervention Type BEHAVIORAL

Adherence Counseling

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Prairie Heart Institute

Springfield, Illinois, United States

Site Status

Memorial Medical Center

Springfield, Illinois, United States

Site Status

Prairie Diagnostic Center

Springfield, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A2581184

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.