Diabetes Medication Choice
April 27, 2015 updated by: Mayo Clinic
Wiser Choices for Patients With Type II Diabetes: Diabetes Medication Choice
The purpose of this study is to examine how different ways of sharing information about diabetes medication treatment options with patients can affect their choices and health.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
85
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- Have a diagnosis of type 2 diabetes mellitus of any duration; c-peptide test not required
- Use 1 or 2 oral hypoglycemic agents; not using insulin therapy
- Are not pregnant
- Have stable but inadequate glycemic control: both A1C at the time of eligibility and previous A1c within 6 months between 7-9.5%
- Recognize their primary care provider as their main diabetes care provider
- Do not have major barriers (i.e., severe hearing impairment, dementia, cannot communicate in English) to participate in shared decision-making (per provider?s assessment)
- Have no plans to relocate out of town in the next 6 months
- Enrolment is open to males and females of diverse racial backgrounds
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Diabetes Medication Choice decision aid
Patients in this arm will discuss diabetes medication for glucose control with the help of a decision aid that covers five commonly prescribed anti-hyperglycemic medications.
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The decision aid covers five commonly prescribed anti-hyperglycemic medications and their attributes.
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Other: Usual Care
Patients and clinicians in this arm will discuss anti-hyperglycemic agents in their usual manner.
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Patients and clinicians in this arm will discuss anti-hyperglycemic agents in their usual manner.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Understanding
Time Frame: Directly proceeding the clinical encounter
|
Directly proceeding the clinical encounter
|
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Decisional Conflict
Time Frame: Directly proceeding the clinical visit
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Directly proceeding the clinical visit
|
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Treatment Action, adherence
Time Frame: Directly proceeding the clinical encounter, 6 months after the clinical encounter
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Directly proceeding the clinical encounter, 6 months after the clinical encounter
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Trust
Time Frame: Directly proceeding the clinical visit
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Directly proceeding the clinical visit
|
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Acceptability
Time Frame: Directly proceeding the clinical encounter
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Directly proceeding the clinical encounter
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Victor M. Montori, M.D., Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wyatt KD, Branda ME, Inselman JW, Ting HH, Hess EP, Montori VM, LeBlanc A. Genders of patients and clinicians and their effect on shared decision making: a participant-level meta-analysis. BMC Med Inform Decis Mak. 2014 Sep 2;14:81. doi: 10.1186/1472-6947-14-81.
- LeBlanc A, Ruud KL, Branda ME, Tiedje K, Boehmer KR, Pencille LJ, Van Houten H, Matthews M, Shah ND, May CR, Yawn BP, Montori VM. The impact of decision aids to enhance shared decision making for diabetes (the DAD study): protocol of a cluster randomized trial. BMC Health Serv Res. 2012 May 28;12:130. doi: 10.1186/1472-6963-12-130.
- Mullan RJ, Montori VM, Shah ND, Christianson TJ, Bryant SC, Guyatt GH, Perestelo-Perez LI, Stroebel RJ, Yawn BP, Yapuncich V, Breslin MA, Pencille L, Smith SA. The diabetes mellitus medication choice decision aid: a randomized trial. Arch Intern Med. 2009 Sep 28;169(17):1560-8. doi: 10.1001/archinternmed.2009.293.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Primary Completion (Actual)
October 1, 2008
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
October 12, 2006
First Submitted That Met QC Criteria
October 12, 2006
First Posted (Estimate)
October 13, 2006
Study Record Updates
Last Update Posted (Estimate)
April 28, 2015
Last Update Submitted That Met QC Criteria
April 27, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-003513
- ADA #33
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.