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The STATIN CHOICE Decision Aid for Type 2 Diabetes Patients

This study is ongoing, but not recruiting participants.
Mayo Clinic
Information provided by:
Icahn School of Medicine at Mount Sinai Identifier:
First received: October 23, 2007
Last updated: May 4, 2009
Last verified: May 2009
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
Other: Statin Choice Decision Aid
Other: Control Pamphlet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The STATIN CHOICE Decision Aid for Type 2 Diabetes Patients

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Morisky medication adherence scale [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]

Enrollment: 152
Study Start Date: August 2007
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Statin Choice Decision Aid
Other: Statin Choice Decision Aid
Paper based instrument with pictures indicating level of risk.
Sham Comparator: 2
Control Pamphlet
Other: Control Pamphlet
ADA Diabetes Sheet


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diabetes

Exclusion Criteria:

  • Not able to speak English or Spanish
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00548639

United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Mayo Clinic
Principal Investigator: Devin Mann, MD, MS Icahn School of Medicine at Mount Sinai
  More Information

Responsible Party: Devin Mann, MD, MS, Mount Sinai School of Medicine Identifier: NCT00548639     History of Changes
Other Study ID Numbers: 06-1415  ISRCTN12345678  NCI-793-0115D 
Study First Received: October 23, 2007
Last Updated: May 4, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents processed this record on January 18, 2017