The STATIN CHOICE Decision Aid for Type 2 Diabetes Patients

Diabetes Clinical Trial

Official title:

The STATIN CHOICE Decision Aid for Type 2 Diabetes Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00548639
• Other study ID #: 06-1415
• Secondary ID: ISRCTN12345678NC
• Status: Completed
• Phase: N/A
• Start date: August 2007
• Est. completion date: April 2010

Study information

• Verified date: March 2019
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

To compare the efficacy of usual consultations with or without the decision aid STATIN CHOICE in type 2 diabetic patients using or considering using statins to lower CV risk in terms of statin use, adherence, knowledge, beliefs and decisional conflict. The study team's primary hypothesis is that 3 months after the index discussion, significantly more patients randomized to STATIN CHOICE are using statins, are adherent to statins, are knowledgeable about the statin choice, and are satisfied with their decision than patients randomized to usual care consultation, and that these benefits will be achieved without deterioration in quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

Eligible providers are

• Internists and nurse practitioners

• Provide care for patients with type 2 diabetes

• Do not plan to relocate outside the practice in the next 6 months.

Eligible patients

• Have a diagnosis of type 2 diabetes mellitus > 1 month confirmed by provider or the medical chart

• Do not take statins, but their providers identify them as eligible for this medication

• Are currently taking statins

Exclusion Criteria:

Ineligible patients

• Have, in the providers' judgment, major barriers such as hearing impairment or dementia that would compromise their participation in shared decisionmaking;

• are not available for follow-up 3 months after randomization

• are pregnant

• are under age 21

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Other:
• Statin Choice Decision Aid
Paper based instrument with pictures indicating level of risk.
• Control Pamphlet
ADA Diabetes Sheet

Locations

Country	Name	City	State
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morisky medication adherence scale		3 months
Primary	Morisky medication adherence scale		6 months