Diabetes Medication Choice

This study has been completed.
Sponsor:
Collaborator:
American Diabetes Association
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00388050
First received: October 12, 2006
Last updated: December 13, 2011
Last verified: December 2011

October 12, 2006
December 13, 2011
July 2006
October 2008   (final data collection date for primary outcome measure)
  • Understanding [ Time Frame: Directly proceeding the clinical encounter ] [ Designated as safety issue: No ]
  • Decisional Conflict [ Time Frame: Directly proceeding the clinical visit ] [ Designated as safety issue: No ]
  • Treatment Action, adherence [ Time Frame: Directly proceeding the clinical encounter, 6 months after the clinical encounter ] [ Designated as safety issue: No ]
  • Understanding
  • Decisional Conflict
  • Treatment Action
Complete list of historical versions of study NCT00388050 on ClinicalTrials.gov Archive Site
  • Trust [ Time Frame: Directly proceeding the clinical visit ] [ Designated as safety issue: No ]
  • Acceptability [ Time Frame: Directly proceeding the clinical encounter ] [ Designated as safety issue: No ]
  • Trust
  • Acceptability
Not Provided
Not Provided
 
Diabetes Medication Choice
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes
Other: Diabetes Medication Choice decision aid
The decision aid covers five commonly prescribed anti-hyperglycemic medications and their attributes.
  • Experimental: 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.
    Intervention: Other: Diabetes Medication Choice decision aid
  • No Intervention: Usual Care
    Patients and clinicians in this arm will discuss anti-hyperglycemic agents in their usual manner.
    Intervention: Other: Diabetes Medication Choice decision aid

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
October 2008
October 2008   (final data collection date for primary outcome measure)
  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00388050
06-003513, ADA #33
Not Provided
Victor Montori, Mayo Clini
Mayo Clinic
American Diabetes Association
Principal Investigator: Victor M. Montori, M.D. Mayo Clinic
Mayo Clinic
December 2011

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