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Diabetes Medication Choice

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00388050
First Posted: October 13, 2006
Last Update Posted: April 28, 2015
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.
Collaborator:
American Diabetes Association
Information provided by:
Mayo Clinic
  Purpose
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 Intervention
Type 2 Diabetes Behavioral: Diabetes Medication Choice decision aid Behavioral: Usual Care

Study Type: Interventional
Study Design: 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

Further study details as provided by Mayo Clinic:

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

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

Enrollment: 85
Study Start Date: July 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
American Diabetes Association
Investigators
Principal Investigator: Victor M. Montori, M.D. Mayo Clinic
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Victor Montori, Mayo Clini
ClinicalTrials.gov Identifier: NCT00388050     History of Changes
Other Study ID Numbers: 06-003513
ADA #33
First Submitted: October 12, 2006
First Posted: October 13, 2006
Last Update Posted: April 28, 2015
Last Verified: April 2015

Keywords provided by Mayo Clinic:
Decision aid, diabetes, primary care

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs