Diabetes Medication Choice - Full Text View

Sponsor:	Mayo Clinic
Collaborator:	American Diabetes Association
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00388050

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

U.S. FDA Resources

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):

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.

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 February 09, 2012