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Effect of a Decision Aid About Statin Use in Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00217061
First Posted: September 22, 2005
Last Update Posted: May 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mayo Clinic
  Purpose

Background- Statins are a safe and effective therapy to reduce cardiovascular risk in patients with type 2 diabetes; however some patients are not prescribed statins, others do not take it even after being prescribed, and others stop therapy prematurely. Lack of knowledge or misinformation about statins may be responsible for inadequate statin use.

Objective- To test the hypothesis that a formal, structured decision aid could correct deficiencies in the current decision-making process, increase statin use, and improve outcomes in patients with type 2 diabetes.

Methods - The investigators will develop a decision aid called STATIN CHOICE and will pilot its efficacy in a blinded randomized controlled trial enrolling 98 type 2 diabetes patients.

Outcomes- Primary outcomes: adherence to the decision to use or not to use statins three months after using STATIN CHOICE. Secondary outcomes: acceptability of STATIN CHOICE, knowledge about options, satisfaction with decisions, decisional conflict, encounter duration, and quality of life.

Expected results- The investigators anticipate that this work will yield an effective and innovative decision aid for statin use in type 2 diabetes patients. STATIN CHOICE, along with a detailed users manual, will be directly applicable in clinical practice. Data and experience from this project will inform the planning and conduct of a randomized multicenter trial of the effectiveness of STATIN CHOICE in diverse practice settings.

Significance- Patient participation in decision-making resulting in informed treatment decisions, as proposed in this study, will likely lead to improved quality of decision-making, more appropriate use of statins, and improved patient outcomes.


Condition Intervention Phase
Diabetes Mellitus Dyslipidemia Hypercholesterolemia Cardiovascular Disease Device: Decision Aid Statin Choice Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Official Title: The Statin Choice Decision Aid and Its Effects on Statin Decisions in Patients With Type 2 Diabetes Mellitus. A Clustered Randomized Trial

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Adherence to the decision to use or not to use statins

Secondary Outcome Measures:
  • Decisional conflict
  • Knowledge and understanding of risk
  • Quality of life (generic and disease specific)
  • Anxiety state
  • Trust in clinician

Estimated Enrollment: 98
Study Start Date: April 2005
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Adult patients with type 2 diabetes attending a referral diabetes clinic, who are taking or not taking statins, and give consent to participate. Excluded were patients who had sensory or mental impairments or language barriers that preclude them from using the intervention and therefore participate in this trial.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00217061


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Victor M. Montori, M.D. Mayo Clinic
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00217061     History of Changes
Other Study ID Numbers: 38-05
First Submitted: September 16, 2005
First Posted: September 22, 2005
Last Update Posted: May 23, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Hypercholesterolemia
Dyslipidemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperlipidemias
Lipid Metabolism Disorders
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents