The STATIN CHOICE Decision Aid for Type 2 Diabetes Patients

This study is ongoing, but not recruiting participants.

First Received: October 23, 2007 Last Updated: May 4, 2009 History of Changes

Sponsors and Collaborators:	Mount Sinai School of Medicine Mayo Clinic
Information provided by:	Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:	NCT00548639

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

MedlinePlus related topics: Diabetes Statins

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Official Title:	The STATIN CHOICE Decision Aid for Type 2 Diabetes Patients

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
1: Experimental Statin Choice Decision Aid	Other: Statin Choice Decision Aid Paper based instrument with pictures indicating level of risk.
2: Sham Comparator 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:	Mount Sinai School of Medicine ( Devin Mann, MD, MS )
Study ID Numbers:	06-1415, ISRCTN12345678, NCI-793-0115D
Study First Received:	October 23, 2007
Last Updated:	May 4, 2009
ClinicalTrials.gov Identifier:	NCT00548639 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Antimetabolites
Metabolic Diseases
Antilipemic Agents
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Anticholesteremic Agents
Endocrinopathy
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Antimetabolites
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Therapeutic Uses
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009