Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Diabetes Medication Choice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00388050
Recruitment Status : Completed
First Posted : October 13, 2006
Last Update Posted : April 28, 2015
Sponsor:
Collaborator:
American Diabetes Association
Information provided by:
Mayo Clinic

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Diabetes Medication Choice decision aid Behavioral: Usual Care Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Wiser Choices for Patients With Type II Diabetes: Diabetes Medication Choice
Study Start Date : July 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.
 Behavioral: Diabetes Medication Choice decision aid
The decision aid covers five commonly prescribed anti-hyperglycemic medications and their attributes.
Usual Care
Patients and clinicians in this arm will discuss anti-hyperglycemic agents in their usual manner.
 Behavioral: Usual Care
Patients and clinicians in this arm will discuss anti-hyperglycemic agents in their usual manner.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Understanding [ Time Frame: Directly proceeding the clinical encounter ]
  2. Decisional Conflict [ Time Frame: Directly proceeding the clinical visit ]
  3. Treatment Action, adherence [ Time Frame: Directly proceeding the clinical encounter, 6 months after the clinical encounter ]

Secondary Outcome Measures :
  1. Trust [ Time Frame: Directly proceeding the clinical visit ]
  2. Acceptability [ Time Frame: Directly proceeding the clinical encounter ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00388050


Locations
Layout table for location information
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
American Diabetes Association
Investigators
Layout table for investigator information
Principal Investigator: Victor M. Montori, M.D. Mayo Clinic
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Victor Montori, Mayo Clini
ClinicalTrials.gov Identifier: NCT00388050    
Other Study ID Numbers: 06-003513
ADA #33
First Posted: October 13, 2006    Key Record Dates
Last Update Posted: April 28, 2015
Last Verified: April 2015
Keywords provided by Mayo Clinic:
Decision aid, diabetes, primary care
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases