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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00217061 |
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Date of registration:
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16/09/2005 |
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Primary sponsor: |
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Public title:
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Effect of a Decision Aid About Statin Use in Patients With Type 2 Diabetes Mellitus
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Scientific title:
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The Statin Choice Decision Aid and Its Effects on Statin Decisions in Patients With Type 2 Diabetes Mellitus. A Clustered Randomized Trial |
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Date of first enrolment:
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April 2005 |
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Target sample size:
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98 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00217061 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind
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Countries of recruitment
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United States
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Contacts
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Name:
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Victor M. Montori, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Key inclusion & exclusion criteria
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Adult patients with type 2 diabetes attending a referral diabetes clinic, who are taking
or not taking statins, and give consent to participate. Excluded were patients who had
sensory or mental impairments or language barriers that preclude them from using the
intervention and therefore participate in this trial.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cardiovascular Disease
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Diabetes Mellitus
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Dyslipidemia
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Hypercholesterolemia
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Intervention(s)
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Device: Decision Aid Statin Choice
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Primary Outcome(s)
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Adherence to the decision to use or not to use statins
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Secondary Outcome(s)
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Anxiety state
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Decisional conflict
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Knowledge and understanding of risk
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Quality of life (generic and disease specific)
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Trust in clinician
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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