Effectiveness Of A Program That Includes Counseling And Patient Support On Adherence To Treatment With Lipitor
NCT01078285
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- 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
- 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
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Effectiveness Of A Program That Includes Counseling And Patient Support On Adherence To Treatment With Lipitor | |||
| Official Title | Impact Of An Integrated Intervention Program On Adherence To Atorvastatin | |||
| 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. | |||
| Detailed Description | Not Provided | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population |
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| Condition | Medication Non-Adherence | |||
| Intervention |
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| Study Groups/Cohorts |
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| 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 Status | Completed | |||
| Actual Enrollment | 500 | |||
| Original Estimated Enrollment | Same as current | |||
| Actual Study Completion Date | November 2011 | |||
| Actual Primary Completion Date | November 2011 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 21 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT01078285 | |||
| Other Study ID Numbers | A2581184 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
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| PRS Account | Pfizer | |||
| Verification Date | July 2015 | |||