The Diabetes Medication Choice Cards Trial in Greece
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01861756|
Recruitment Status : Completed
First Posted : May 24, 2013
Results First Posted : March 13, 2017
Last Update Posted : March 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Other: Diabetes Medication Choice decision aid||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||204 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||The Diabetes Medication Choice Cards Trial in Greece|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||August 2014|
|Experimental: Diabetes Medication Choice Decision Aid||
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.
|No Intervention: Standard care|
- Overall Decisional Comfort (0-100, 100=no Conflict) [ Time Frame: Day 1 ]Quality of the decision making process assessed by means of the Decisional Conflict Scale
- Degree of Patient Knowledge About Available Treatment Alternatives [ Time Frame: Day 1 ]Patients will complete a 6-item questionnaire addressing general knowledge about type 2 diabetes.
- Patient and Clinician Satisfaction With the Decision Making Process [ Time Frame: 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.
- Adherence With Antihyperglycemic Regimens as Reported by the Patient Himself/Herself or Assessed Utilizing the Pharmacy Records [ Time Frame: 3 and 6 months after patient initial encounter ]
- Glycemic Control (HbA1c) [ Time Frame: 3 and 6 months after patient initial encounter ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01861756
|Tzanio General Hospital|
|Piraeus, Attiki, Greece|
|Nea Michaniona Health Center|
|Nea Michaniona, Thessaloniki, Greece|
|Neapoli, Thessaloniki, Greece|
|Thermi, Thessaloniki, Greece|
|Alexandroupoli University Hospital|
|NIMTS Military Hospital|
|Polikliniki General Hospital|
|Principal Investigator:||Apostolos Tsapas, MD, MSc, PhD||Aristotle University Of Thessaloniki|