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Study Summary
No. 2006-0743:.......Other Studies......Maria Suarez-Almazor......General Internal Medicine/Ambulatory Treatment & Emergency Care
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Study Summary Title
Study Summary
Number:
2006-0743
Study Title:Informed Decision-Making about Statins in Low Literacy Primary Care Patients
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Physician New Patient Referral
Name:Maria Suarez-AlmazorPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:General Internal Medicine/Ambulatory Treatment & Emergency CareReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-9064
Contact us about clinical trials
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General Information
Disease Group:Other StudiesSupported By:N/A
Phase of Study:Phase IIReturn
Visit:
NA
Treatment
Agents:
NoneHome Care:NA
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
NA
Description/
Intervention:
Unavailable
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Study Objectives / Outcomes
Dr. Suarez-Almazor's role will be to oversee and direct the analysis of data from the Baylor College of Medicine study regarding decision making about statins for high cholesterol patients. The Baylor team, under a subcontract with UTMDACC and Dr. Suarez-Almazor, will develop and pilot test a new decision aid for high-risk minority patients with low literacy levels that have hypercholesterolemia and are considering treatment with a statin. They will create a "statin informed choice" tool as a CD audio booklet. It will feature simplified graphics and content written at a 6th grade reading level. Development and testing will involve 60 patients with low socioeconomic status who read below 7th grade level. All patients will be recruited at Harris County Hospital District clinics. Data will be collected by Baylor College of Medicine Family Medicine investigators. Once collected, the data will be transferred to UTMDACC and Dr. Suarez-Almazor will manage and analyze the data. No UTMDACC patients will be enrolled in this protocol. The patients that are enrolled in the study will be informed that the data will be stored at and analyzed by UTMDACC investigators.
Aim 1 - To develop a new statin decision aid for low-literacy patients. To address Aim 1 Dr. Suarez-Almazor will analyze qualitative data from focus groups and individual interviews conducted by BCM investigators.The BCM research team will conduct 18 individual interviews and two focus groups of hypercholesterolemic patients with low literacy levels.
Aim 2 - To evaluate the potential efficacy of the statin decision aid. To address Aim 2 Dr. Suarez-Almazor will analyze the data from the pilot conducted by BCM investigators.
BCM investigators will conduct a pilot intervention with 120 low-literacy, low-income, hypercholesterolemic adults.
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Study Status Information
Study Activation / Registration Date:
IRB Review and Approval Date:06/29/2007
Study Type:Behavioral
Recruitment Status:Open
Projected Accrual:138
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) NO UTMDACC Paitents will be enrolled in this study.

Exclusion Criteria:1) No UTMDACC Patients will be enrolled in this study.

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Links
Registration Number: Not Registered

Other Links:
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Results


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