Type 2 Diabetes
Conditions
Keywords
Decision aid, diabetes, primary care
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.
Interventions
BEHAVIORALDiabetes Medication Choice decision aid
The decision aid covers five commonly prescribed anti-hyperglycemic medications and their attributes.
BEHAVIORALUsual Care
Patients and clinicians in this arm will discuss anti-hyperglycemic agents in their usual manner.
Sponsors
American Diabetes Association
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Trust | Directly proceeding the clinical visit |
| Acceptability | Directly proceeding the clinical encounter |
Countries
United States
Outcome results
None listed