Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:01 PM
Ignite Modification Date:
2025-12-24 @ 12:01 PM
NCT ID:
NCT00217061
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.
Study:
NCT00217061
Study Brief:
Protocol Section:
NCT00217061