Effect of a Decision Aid About Statin Use in Patients With Type 2 Diabetes Mellitus
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind |
| Official Title: | The Statin Choice Decision Aid and Its Effects on Statin Decisions in Patients With Type 2 Diabetes Mellitus. A Clustered Randomized Trial |
- Adherence to the decision to use or not to use statins
- 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 More Information
No publications provided by Mayo Clinic
Additional 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 |
| Study First Received: | September 16, 2005 |
| Last Updated: | May 20, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 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 Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013