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

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NCT01078285

Last updated on October 10, 2019
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Study Location
Prairie Heart Institute
Springfield, Illinois, 62701 United States
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Medication Non-Adherence
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01078285
Pfizer
Completed
Effectiveness Of A Program That Includes Counseling And Patient Support On Adherence To Treatment With Lipitor

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Descriptive Information
Brief TitleEffectiveness Of A Program That Includes Counseling And Patient Support On Adherence To Treatment With Lipitor
Official TitleImpact Of An Integrated Intervention Program On Adherence To Atorvastatin
Brief SummaryDespite 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 DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
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
ConditionMedication Non-Adherence
Intervention
  • Behavioral: No Patient Counseling
    Patients do not receive any adherence counseling, or other patient support services
  • Behavioral: Adherence Counseling
    Patients receive 3-5 minutes of adherence counseling, and other patient support services
Study Groups/Cohorts
  • Control
    Intervention: Behavioral: No Patient Counseling
  • Intervention Arm
    Intervention: Behavioral: Adherence Counseling
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: February 26, 2010)		500
Original Estimated EnrollmentSame as current
Actual Study Completion DateNovember 2011
Actual Primary Completion DateNovember 2011   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study:All
Ages21 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesUnited States
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01078285
Other Study ID NumbersA2581184
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJuly 2015

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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