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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
Sponsor:
Collaborators:
European Foundation for the Study of Diabetes
Mayo Clinic
Information provided by (Responsible Party):
Apostolos Tsapas, Aristotle University Of Thessaloniki

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Other: Diabetes Medication Choice decision aid Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.


  3. 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 ]
  4. Glycemic Control (HbA1c) [ Time Frame: 3 and 6 months after patient initial encounter ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Greece
Tzanio General Hospital
Piraeus, Attiki, Greece
Nea Michaniona Health Center
Nea Michaniona, Thessaloniki, Greece
Private practice
Neapoli, Thessaloniki, Greece
Thermi S.A.
Thermi, Thessaloniki, Greece
Alexandroupoli University Hospital
Alexandroupoli, Greece
NIMTS Military Hospital
Athens, Greece
Polikliniki General Hospital
Athens, Greece
Private practice
Serres, Greece
Sponsors and Collaborators
Aristotle University Of Thessaloniki
European Foundation for the Study of Diabetes
Mayo Clinic
Investigators
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Principal Investigator: Apostolos Tsapas, MD, MSc, PhD Aristotle University Of Thessaloniki
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Apostolos Tsapas, Assistant Professor of Medicine, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT01861756    
Other Study ID Numbers: AUTH87963
U1111-1138-2901 ( Other Identifier: WHO - Universal Trial Number )
First Posted: May 24, 2013    Key Record Dates
Results First Posted: March 13, 2017
Last Update Posted: March 13, 2017
Last Verified: January 2017
Keywords provided by Apostolos Tsapas, Aristotle University Of Thessaloniki:
Shared Decision Making
Decision Aids
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases