The Diabetes Medication Choice Cards Trial in Greece

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

The Diabetes Medication Choice Cards Trial in Greece

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01861756
• Other study ID #: AUTH87963
• Secondary ID: U1111-1138-2901
• Status: Completed
• Phase: N/A
• First received: May 20, 2013
• Last updated: September 8, 2014
• Start date: May 2013
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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 facilitator for the Shared Decision Making process.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: August 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Other:
• Diabetes Medication Choice decision aid
The Diabetes Medication Choice decision aid cards provide information about medications commonly used to treat type 2 diabetes mellitus. The tool was originally developed and successfully evaluated by Mayo Clinic researchers.

Locations

Country	Name	City	State
Greece	Alexandroupoli University Hospital	Alexandroupoli
Greece	NIMTS Military Hospital	Athens
Greece	Polikliniki General Hospital	Athens
Greece	Nea Michaniona Health Center	Nea Michaniona	Thessaloniki
Greece	Private practice	Neapoli	Thessaloniki
Greece	Tzanio General Hospital	Piraeus	Attiki
Greece	Private practice	Serres
Greece	Thermi S.A.	Thermi	Thessaloniki

Sponsors (3)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki	European Foundation for the Study of Diabetes, Mayo Clinic

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of the decision making process assessed by means of the Decisional Conflict Scale		Day 1	No
Secondary	Degree of patient knowledge about available treatment alternatives	Patients will complete a 6-item questionnaire addressing general knowledge about type 2 diabetes.	Day 1	No
Secondary	Patient and clinician satisfaction with the decision making process	Patient satisfaction will be assessed using items from the Decisional Conflict Scale as well as two specific questions that require patients to assess the extent to which they would want for themselves and recommend to others similar decision support.; Clinician satisfaction will be assessed using a 6-point likert-type question asking about their satisfaction regarding the discussion they had with their patient.	Day 1	No
Secondary	Adherence with antihyperglycemic regimens as reported by the patient himself/herself or assessed utilizing the pharmacy records		3 and 6 months after patient initial encounter	No
Secondary	Glycemic control (HbA1c)		3 and 6 months after patient initial encounter	No