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Completed

NCT Number: NCT00217061

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

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.

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Key information

Conditions

Diabetes Mellitus Cardiovascular Disease Cardiovascular Diseases Dyslipidemia Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Decision Aid Statin Choice

Device

Primary outcomes

  1. Adherence to the decision to use or not to use statins

Secondary outcomes

  1. Decisional conflict

  2. Knowledge and understanding of risk

  3. Quality of life (generic and disease specific)

  4. Anxiety state

  5. Trust in clinician

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

The Statin Choice Decision Aid and Its Effects on Statin Decisions in Patients With Type 2 Diabetes Mellitus. A Clustered Randomized Trial

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Sep 22, 2005
Registry last updated
May 23, 2011

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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