The Diabetes Medication Choice Cards Trial in Greece

Aristotle University Of Thessaloniki

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Treatments

Other: Diabetes Medication Choice decision aid

Study type

Interventional

Funder types

Other

Identifiers

NCT01861756

U1111-1138-2901 (Other Identifier)

AUTH87963

Details and patient eligibility

About

A cluster randomized trial to assess the efficacy of the Diabetes Medication Choice decision aid among Greek patients with type 2 diabetes mellitus compared with usual care. The tool will serve as a facilitator for the Shared Decision Making process.

Enrollment

204 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Type 2 diabetes mellitus for more than one year
Agree to be followed for at least 6 months
Willing to respond to survey questions immediately following the visit
HbA1c value between 7.5% and 10%
Need treatment intensification and there are more than one available treatment options

Exclusion criteria

Decide not to intensify treatment or to intensify treatment through lifestyle modification, which is a sine qua non for diabetes treatment
Is to transfer to another practice within the next 6 months
Significant cognitive (e.g. dementia) or sensory limitations (e.g. blind) or other reasons (e.g. fatigue, limited attention, sleep deprivation) for which, in the judgment of the study personnel, they could not reasonably provide written informed consent or be able to use the decision aid
Planning to enter a long-term care facility (e.g. nursing home) where medications will be administered by clinical personnel after hospital discharge
Enrolled in other studies that require prolonged participation and follow-up
Unable to speak Greek at a level necessary to complete the patient surveys and ensure involvement in decision making
Women known to be pregnant