NCT00388050

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Jul 2006

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

2.3 years

First QC Date

October 12, 2006

Last Update Submit

April 27, 2015

Conditions

Type 2 Diabetes

Keywords

Decision aid, diabetes, primary care

Outcome Measures

Primary Outcomes (3)

  • Understanding

    Directly proceeding the clinical encounter

  • Decisional Conflict

    Directly proceeding the clinical visit

  • Treatment Action, adherence

    Directly proceeding the clinical encounter, 6 months after the clinical encounter

Secondary Outcomes (2)

  • Trust

    Directly proceeding the clinical visit

  • Acceptability

    Directly proceeding the clinical encounter

Study Arms (2)

Diabetes Medication Choice decision aid

EXPERIMENTAL

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

Usual Care

OTHER

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

Behavioral: Usual Care

Interventions

Diabetes Medication Choice decision aidBEHAVIORAL

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

Diabetes Medication Choice decision aid
Usual CareBEHAVIORAL

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

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (3)

  • 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.

    PMID: 25179289DERIVED

  • 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.

    PMID: 22640439DERIVED

  • 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.

    PMID: 19786674DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Victor M. Montori, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 12, 2006

First Posted

October 13, 2006

Study Start

July 1, 2006

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

April 28, 2015

Record last verified: 2015-04

Locations

US(1)