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The STATIN CHOICE Decision Aid for Type 2 Diabetes Patients
This study is currently recruiting participants.
Verified by Mount Sinai School of Medicine, May 2008
Sponsors and Collaborators: Mount Sinai School of Medicine
Mayo Clinic
Information provided by: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00548639
  Purpose

Diabetes is a growing epidemic within the United States that disproportionately affects economically disadvantaged communities like East Harlem. As diabetic patients are at very high risk for heart disease, experts recommend an aggressive approach towards using statins in people with diabetes. However, statins and other helpful drugs are only effective if patients decide to take them. Adherence to this medication is notoriously poor and is aggravated by its required life-long use. This study is designed to test the effectiveness of a new decision aid in helping diverse, inner-city patients with diabetes understand the risks and benefits in taking statins and whether this enhanced decision making process improves their adherence to the medication.


Condition Intervention
Diabetes
Other: Statin Choice Decision Aid
Other: Control Pamphlet

MedlinePlus related topics: Diabetes Statins
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Official Title: The STATIN CHOICE Decision Aid for Type 2 Diabetes Patients

Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Morisky medication adherence scale

Study Start Date: August 2007
Arms Assigned Interventions
1: Experimental
Statin Choice Decision Aid
Other: Statin Choice Decision Aid
2: Sham Comparator
Control Pamphlet
Other: Control Pamphlet

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetes

Exclusion Criteria:

  • Not able to speak English or Spanish
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00548639

Contacts
Contact: Jacqueline Arciniega 212-824-7493 jacqueline.arciniega@mssm.edu

Locations
United States, New York
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Sub-Investigator: Thomas McGinn, MD, Ph.D.            
Sponsors and Collaborators
Mount Sinai School of Medicine
Mayo Clinic
Investigators
Principal Investigator: Devin Mann, MD, MS Mount Sinai School of Medicine
  More Information

Study ID Numbers: 06-1415, ISRCTN12345678, NCI-793-0115D
Study First Received: October 23, 2007
Last Updated: May 23, 2008
ClinicalTrials.gov Identifier: NCT00548639  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 15, 2009