This trial is active, not recruiting.

Condition diabetes
Treatments statin choice decision aid, control pamphlet
Sponsor Mount Sinai School of Medicine
Collaborator Mayo Clinic
Start date August 2007
End date April 2010
Trial size 152 participants
Trial identifier NCT00548639, 06-1415, ISRCTN12345678, NCI-793-0115D


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Statin Choice Decision Aid
statin choice decision aid
Paper based instrument with pictures indicating level of risk.
(Sham Comparator)
Control Pamphlet
control pamphlet
ADA Diabetes Sheet

Primary Outcomes

Morisky medication adherence scale
time frame: 3 months and 6 months

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: - Diabetes Exclusion Criteria: - Not able to speak English or Spanish

Additional Information

Official title The STATIN CHOICE Decision Aid for Type 2 Diabetes Patients
Principal investigator Devin Mann, MD, MS
Trial information was received from ClinicalTrials.gov and was last updated in May 2009.
Information provided to ClinicalTrials.gov by Mount Sinai School of Medicine.