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Effect of a Decision Aid About Statin Use in Patients With Type 2 Diabetes Mellitus
This study has been completed.
Study NCT00217061   Information provided by Mayo Clinic
First Received: September 16, 2005   No Changes Posted

September 16, 2005
September 16, 2005
April 2005
 
Adherence to the decision to use or not to use statins
Same as current
No Changes Posted
  • Decisional conflict
  • Knowledge and understanding of risk
  • Quality of life (generic and disease specific)
  • Anxiety state
  • Trust in clinician
Same as current
 
Effect of a Decision Aid About Statin Use in Patients With Type 2 Diabetes Mellitus
The Statin Choice Decision Aid and Its Effects on Statin Decisions in Patients With Type 2 Diabetes Mellitus. A Clustered Randomized Trial

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.

 
Phase III
Interventional
Educational/Counseling/Training, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
  • Diabetes Mellitus
  • Dyslipidemia
  • Hypercholesterolemia
  • Cardiovascular Disease
Device: Decision Aid Statin Choice
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
98
October 2005
 

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00217061
 
38-05
Mayo Clinic
 
Principal Investigator: Victor M. Montori, M.D. Mayo Clinic
Mayo Clinic
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP