Diabetes Mellitus Clinical Trial
Official title:
The Statin Choice Decision Aid and Its Effects on Statin Decisions in Patients With Type 2 Diabetes Mellitus. A Clustered Randomized Trial
| Verified date | May 2011 |
| Source | Mayo Clinic |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 98 |
| Est. completion date | October 2005 |
| Est. primary completion date | October 2005 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility | 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind
| Country | Name | City | State |
|---|---|---|---|
| United States | Mayo Clinic | Rochester | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| Mayo Clinic |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Adherence to the decision to use or not to use statins | |||
| Secondary | Decisional conflict | |||
| Secondary | Knowledge and understanding of risk | |||
| Secondary | Quality of life (generic and disease specific) | |||
| Secondary | Anxiety state | |||
| Secondary | Trust in clinician |
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