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The Diabetes Medication Choice Cards Trial in Greece

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Diabetes Medication Choice decision aid
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus, Type 2 focused on measuring Shared Decision Making, Decision Aids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tzanio General Hospital
  • Nea Michaniona Health Center
  • Private practice
  • Thermi S.A.
  • Alexandroupoli University Hospital
  • NIMTS Military Hospital
  • Polikliniki General Hospital
  • Private practice

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Diabetes Medication Choice Decision Aid

Standard care

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Degree of Patient Knowledge About Available Treatment Alternatives
Patients will complete a 6-item questionnaire addressing general knowledge about type 2 diabetes.
Patient and Clinician Satisfaction With the Decision Making Process
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
Glycemic Control (HbA1c)

Full Information

First Posted
May 20, 2013
Last Updated
January 23, 2017
Sponsor
Aristotle University Of Thessaloniki
Collaborators
European Foundation for the Study of Diabetes, Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01861756
Brief Title
The Diabetes Medication Choice Cards Trial in Greece
Official Title
The Diabetes Medication Choice Cards Trial in Greece
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki
Collaborators
European Foundation for the Study of Diabetes, Mayo Clinic

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Shared Decision Making, Decision Aids

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diabetes Medication Choice Decision Aid
Arm Type
Experimental
Arm Title
Standard care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Diabetes Medication Choice decision aid
Intervention Description
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 Outcome Measure Information:
Title
Overall Decisional Comfort (0-100, 100=no Conflict)
Description
Quality of the decision making process assessed by means of the Decisional Conflict Scale
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Degree of Patient Knowledge About Available Treatment Alternatives
Description
Patients will complete a 6-item questionnaire addressing general knowledge about type 2 diabetes.
Time Frame
Day 1
Title
Patient and Clinician Satisfaction With the Decision Making Process
Description
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.
Time Frame
Day 1
Title
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
Title
Glycemic Control (HbA1c)
Time Frame
3 and 6 months after patient initial encounter

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Apostolos Tsapas, MD, MSc, PhD
Organizational Affiliation
Aristotle University Of Thessaloniki
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tzanio General Hospital
City
Piraeus
State/Province
Attiki
Country
Greece
Facility Name
Nea Michaniona Health Center
City
Nea Michaniona
State/Province
Thessaloniki
Country
Greece
Facility Name
Private practice
City
Neapoli
State/Province
Thessaloniki
Country
Greece
Facility Name
Thermi S.A.
City
Thermi
State/Province
Thessaloniki
Country
Greece
Facility Name
Alexandroupoli University Hospital
City
Alexandroupoli
Country
Greece
Facility Name
NIMTS Military Hospital
City
Athens
Country
Greece
Facility Name
Polikliniki General Hospital
City
Athens
Country
Greece
Facility Name
Private practice
City
Serres
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
28186933
Citation
Karagiannis T, Liakos A, Branda ME, Athanasiadou E, Mainou M, Boura P, Goulis DG, LeBlanc A, Montori VM, Tsapas A. Use of the Diabetes Medication Choice Decision Aid in patients with type 2 diabetes in Greece: a cluster randomised trial. BMJ Open. 2016 Nov 14;6(11):e012185. doi: 10.1136/bmjopen-2016-012185.
Results Reference
derived

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The Diabetes Medication Choice Cards Trial in Greece

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