Diabetes Medication Choice

NCT ID: NCT00388050

Last Updated: 2015-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Diabetes Medication Choice decision aid

Intervention Type BEHAVIORAL

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.

Group Type OTHER

Usual Care

Intervention Type BEHAVIORAL

Patients and clinicians in this arm will discuss anti-hyperglycemic agents in their usual manner.

Interventions

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Diabetes Medication Choice decision aid

The decision aid covers five commonly prescribed anti-hyperglycemic medications and their attributes.

Intervention Type BEHAVIORAL

Usual Care

Patients and clinicians in this arm will discuss anti-hyperglycemic agents in their usual manner.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Diabetes Association

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mayo Clini

Principal Investigators

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Victor M. Montori, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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Wyatt KD, Branda ME, Inselman JW, Ting HH, Hess EP, Montori VM, LeBlanc A. Genders of patients and clinicians and their effect on shared decision making: a participant-level meta-analysis. BMC Med Inform Decis Mak. 2014 Sep 2;14:81. doi: 10.1186/1472-6947-14-81.

Reference Type DERIVED
PMID: 25179289 (View on PubMed)

LeBlanc A, Ruud KL, Branda ME, Tiedje K, Boehmer KR, Pencille LJ, Van Houten H, Matthews M, Shah ND, May CR, Yawn BP, Montori VM. The impact of decision aids to enhance shared decision making for diabetes (the DAD study): protocol of a cluster randomized trial. BMC Health Serv Res. 2012 May 28;12:130. doi: 10.1186/1472-6963-12-130.

Reference Type DERIVED
PMID: 22640439 (View on PubMed)

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. doi: 10.1001/archinternmed.2009.293.

Reference Type DERIVED
PMID: 19786674 (View on PubMed)

Other Identifiers

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ADA #33

Identifier Type: -

Identifier Source: secondary_id

06-003513

Identifier Type: -

Identifier Source: org_study_id

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