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Completed

NCT Number: NCT01861756

The Diabetes Medication Choice Cards Trial in Greece

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tzanio General Hospital, Piraeus, Attica, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diabetes Medication Choice decision aid

Other

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Collaborators

  • European Foundation for the Study of Diabetes
  • Mayo Clinic

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 24, 2013
Registry last updated
Mar 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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