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The STATIN CHOICE Decision Aid for Type 2 Diabetes Patients

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ClinicalTrials.gov Identifier: NCT00548639
Recruitment Status : Unknown
Verified May 2009 by Icahn School of Medicine at Mount Sinai.
Recruitment status was:  Active, not recruiting
First Posted : October 24, 2007
Last Update Posted : May 5, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Diabetes Other: Statin Choice Decision Aid Other: Control Pamphlet

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The STATIN CHOICE Decision Aid for Type 2 Diabetes Patients
Study Start Date : August 2007
Estimated Primary Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Statins
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Morisky medication adherence scale [ Time Frame: 3 months and 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Diabetes

Exclusion Criteria:

  • Not able to speak English or Spanish
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00548639


Locations
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
Investigators
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
ClinicalTrials.gov Identifier: NCT00548639     History of Changes
Other Study ID Numbers: 06-1415
ISRCTN12345678
NCI-793-0115D
First Posted: October 24, 2007    Key Record Dates
Last Update Posted: May 5, 2009
Last Verified: May 2009

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents