The Diabetes Medication Choice Cards Trial in Greece

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Diabetes Medication Choice decision aid

• Registration Number: NCT01861756
• Lead Sponsor: Aristotle University Of Thessaloniki

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 facilitator for the Shared Decision Making process.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-20
• Study First Submitted QC: 2013-05-22
• Study First Posted: 2013-05-24
• Primary Completion: 2014-02
• Study Completion: 2014-08
• Status Verified: 2017-01
• Results First Submitted: 2017-01-23
• Results First Submitted QC: 2017-01-23
• Last Update Submitted: 2017-01-23
• Results First Posted: 2017-03-13
• Last Update Posted: 2017-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diabetes Medication Choice Decision Aid	Diabetes Medication Choice decision aid	-

Primary Outcome Measures

Name	Time	Method
Overall Decisional Comfort (0-100, 100=no Conflict)	Day 1	Quality of the decision making process assessed by means of the Decisional Conflict Scale

Secondary Outcome Measures

Name	Time	Method
Glycemic Control (HbA1c)	3 and 6 months after patient initial encounter
Patient and Clinician Satisfaction With the Decision Making Process	Day 1	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.
Degree of Patient Knowledge About Available Treatment Alternatives	Day 1	Patients will complete a 6-item questionnaire addressing general knowledge about type 2 diabetes.
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

Trial Locations

Locations (7)

Nea Michaniona Health Center; 🇬🇷 Nea Michaniona, Thessaloniki, Greece

Alexandroupoli University Hospital; 🇬🇷 Alexandroupoli, Greece

Polikliniki General Hospital; 🇬🇷 Athens, Greece

Private practice; 🇬🇷 Serres, Greece

Tzanio General Hospital; 🇬🇷 Piraeus, Attiki, Greece

Thermi S.A.; 🇬🇷 Thermi, Thessaloniki, Greece

NIMTS Military Hospital; 🇬🇷 Athens, Greece