Status:
COMPLETED
The Diabetes Medication Choice Cards Trial in Greece
Lead Sponsor:
Aristotle University Of Thessaloniki
Collaborating Sponsors:
European Foundation for the Study of Diabetes
Mayo Clinic
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT01861756
Start Date
May 1 2013
End Date
August 1 2014
Last Update
March 13 2017
Active Locations (8)
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1
Tzanio General Hospital
Piraeus, Attica, Greece
2
Private practice
Neapoli, Thessaloniki, Greece
3
Nea Michaniona Health Center
Néa Michanióna, Thessaloniki, Greece
4
Thermi S.A.
Thermi, Thessaloniki, Greece