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
  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
Other: Diabetes Medication Choice decision aid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Wiser Choices for Patients With Type II Diabetes: Diabetes Medication Choice

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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: 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.
Other: Diabetes Medication Choice decision aid
The decision aid covers five commonly prescribed anti-hyperglycemic medications and their attributes.
No Intervention: Usual Care
Patients and clinicians in this arm will discuss anti-hyperglycemic agents in their usual manner.
Other: Diabetes Medication Choice decision aid
The decision aid covers five commonly prescribed anti-hyperglycemic medications and their attributes.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Mayo Clinic

Additional 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
Study First Received: October 12, 2006
Last Updated: December 13, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014