The STATIN CHOICE Decision Aid for Type 2 Diabetes Patients

March 20, 2019 updated by: Icahn School of Medicine at Mount Sinai
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Statin Choice
Statin Choice Decision Aid The provider will introduce the patient to the choice of statins using the decision aid. The patient may make a choice then or defer this choice; in all cases, the patient goes home with the Statin Choice decision aid and pamphlet.
Other: Statin Choice Decision Aid
Paper based instrument with pictures indicating level of risk.
Sham Comparator: Usual Care
Control Pamphlet the provider meets with the patient to discuss treatment options in the usual fashion.
Other: Control Pamphlet
ADA Diabetes Sheet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Morisky medication adherence scale
Time Frame: 3 months
3 months
Morisky medication adherence scale
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

Mayo Clinic

Investigators

  • Principal Investigator: Devin Mann, MD, MS, Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

October 23, 2007

First Submitted That Met QC Criteria

October 23, 2007

First Posted (Estimate)

October 24, 2007

Study Record Updates

Last Update Posted (Actual)

March 22, 2019

Last Update Submitted That Met QC Criteria

March 20, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-1415
  • ISRCTN12345678
  • NCI-793-0115D

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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