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The STATIN CHOICE Decision Aid for Type 2 Diabetes Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Mount Sinai School of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Mayo Clinic
Information provided by:
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00548639
First received: October 23, 2007
Last updated: May 4, 2009
Last verified: May 2009
History of Changes
  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

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:

U.S. FDA Resources

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

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

  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

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

No publications provided

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
Study First Received: October 23, 2007
Last Updated: May 4, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013