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OpenTrials
Completed

NCT Number: NCT00548639

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai School of Medicine

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Statin Choice Decision Aid

Other

Paper based instrument with pictures indicating level of risk.

Control Pamphlet

Other

ADA Diabetes Sheet

Primary outcomes

  1. Morisky medication adherence scale

    Time frame: 3 months

  2. Morisky medication adherence scale

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Mayo Clinic

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Oct 24, 2007
Registry last updated
Mar 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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