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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 16, 2005 | ||||
| Last Updated Date | September 16, 2005 | ||||
| Start Date ICMJE | April 2005 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Adherence to the decision to use or not to use statins | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of a Decision Aid About Statin Use in Patients With Type 2 Diabetes Mellitus | ||||
| Official Title ICMJE | The Statin Choice Decision Aid and Its Effects on Statin Decisions in Patients With Type 2 Diabetes Mellitus. A Clustered Randomized Trial | ||||
| Brief Summary | 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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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Educational/Counseling/Training, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Device: Decision Aid Statin Choice | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Weymiller AJ, Montori VM, Jones LA, Gafni A, Guyatt GH, Bryant SC, Christianson TJ, Mullan RJ, Smith SA. Helping patients with type 2 diabetes mellitus make treatment decisions: statin choice randomized trial. Arch Intern Med. 2007 May 28;167(10):1076-82. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 98 | ||||
| Completion Date | October 2005 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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. |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00217061 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 38-05 | ||||
| Study Sponsor ICMJE | Mayo Clinic | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Mayo Clinic | ||||
| Verification Date | September 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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