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NCT00217061 · ClinicalTrials.gov registry record · Phase 3
Effect of a Decision Aid About Statin Use in Patients With Type 2 Diabetes Mellitus
A Phase 3 study of Diabetes Mellitus and Cardiovascular Disease, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 3
- Development phase
- 98
- Enrollment target
- 1
- Study location
NCT00217061: Completed Phase 3 study of Diabetes Mellitus and Cardiovascular Disease, sponsored by Mayo Clinic.
NCT00217061 is a Phase 3 study of Diabetes Mellitus and Cardiovascular Disease that has completed, run by Mayo Clinic. The registered enrollment target is 98 participants, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00217061, a Phase 3 study of Diabetes Mellitus and Cardiovascular Disease, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 98 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DEVICE Decision Aid Statin Choice
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2005-04 |
| Est. Completion | 2005-10 |
| Phase | Phase 3 |
What the finished NCT00217061 record still lists
NCT00217061 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (95% lower).
The record links to 4 conditions, with Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention - of which Decision Aid Statin Choice is the first listed.
NCT00217061 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT00217061 about?
NCT00217061 is a clinical study titled "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 sta...
What is the current status of trial NCT00217061?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 98 participants. The study started on 2005-04. Estimated completion is 2005-10.
What conditions does trial NCT00217061 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Cardiovascular Disease, Hypercholesterolemia, Dyslipidemia.
What interventions are being tested in trial NCT00217061?
The interventions under investigation include: Decision Aid Statin Choice (DEVICE).
Who is sponsoring clinical trial NCT00217061?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00217061 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00217061's enrollment target sits among peer trials
98 124th of 208 higher than 85 of 208 other Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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