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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

October 23, 2007
May 4, 2009
August 2007
April 2010   (final data collection date for primary outcome measure)
Morisky medication adherence scale [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]
Morisky medication adherence scale
Complete list of historical versions of study NCT00548639 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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The STATIN CHOICE Decision Aid for Type 2 Diabetes Patients
The STATIN CHOICE Decision Aid for Type 2 Diabetes Patients

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes
  • Other: Statin Choice Decision Aid
    Paper based instrument with pictures indicating level of risk.
  • Other: Control Pamphlet
    ADA Diabetes Sheet
  • Experimental: 1
    Statin Choice Decision Aid
    Intervention: Other: Statin Choice Decision Aid
  • Sham Comparator: 2
    Control Pamphlet
    Intervention: Other: Control Pamphlet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
152
Not Provided
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diabetes

Exclusion Criteria:

  • Not able to speak English or Spanish
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00548639
06-1415, ISRCTN12345678, NCI-793-0115D
No
Devin Mann, MD, MS, Mount Sinai School of Medicine
Mount Sinai School of Medicine
Mayo Clinic
Principal Investigator: Devin Mann, MD, MS Mount Sinai School of Medicine
Mount Sinai School of Medicine
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP