The Diabetes Medication Choice Cards Trial in Greece

January 23, 2017 updated by: Apostolos Tsapas, Aristotle University Of Thessaloniki
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Alexandroupoli, Greece
        • Alexandroupoli University Hospital
      • Athens, Greece
        • NIMTS Military Hospital
      • Athens, Greece
        • Polikliniki General Hospital
      • Serres, Greece
        • Private Practice
    • Attiki
      • Piraeus, Attiki, Greece
        • Tzanio General Hospital
    • Thessaloniki
      • Nea Michaniona, Thessaloniki, Greece
        • Nea Michaniona Health Center
      • Neapoli, Thessaloniki, Greece
        • Private Practice
      • Thermi, Thessaloniki, Greece
        • Thermi S.A.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1
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.
Day 1
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
3 and 6 months after patient initial encounter
Glycemic Control (HbA1c)
Time Frame: 3 and 6 months after patient initial encounter
3 and 6 months after patient initial encounter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Collaborators

Mayo Clinic
European Foundation for the Study of Diabetes

Investigators

  • Principal Investigator: Apostolos Tsapas, MD, MSc, PhD, Aristotle University Of Thessaloniki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

May 20, 2013

First Submitted That Met QC Criteria

May 22, 2013

First Posted (Estimate)

May 24, 2013

Study Record Updates

Last Update Posted (Actual)

March 13, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUTH87963
  • U1111-1138-2901 (Other Identifier: WHO - Universal Trial Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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