The Diabetes Medication Choice Cards Trial in Greece
2 other identifiers
interventional
204
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started May 2013
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 20, 2013
CompletedFirst Posted
Study publicly available on registry
May 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
March 13, 2017
CompletedMarch 13, 2017
January 1, 2017
9 months
May 20, 2013
January 23, 2017
January 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Decisional Comfort (0-100, 100=no Conflict)
Quality of the decision making process assessed by means of the Decisional Conflict Scale
Day 1
Secondary Outcomes (4)
Degree of Patient Knowledge About Available Treatment Alternatives
Day 1
Patient and Clinician Satisfaction With the Decision Making Process
Day 1
Adherence With Antihyperglycemic Regimens as Reported by the Patient Himself/Herself or Assessed Utilizing the Pharmacy Records
3 and 6 months after patient initial encounter
Glycemic Control (HbA1c)
3 and 6 months after patient initial encounter
Study Arms (2)
Diabetes Medication Choice Decision Aid
EXPERIMENTALStandard care
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aristotle University Of Thessalonikilead
- European Foundation for the Study of Diabetescollaborator
- Mayo Cliniccollaborator
Study Sites (8)
Tzanio General Hospital
Piraeus, Attica, Greece
Private practice
Neapoli, Thessaloniki, Greece
Nea Michaniona Health Center
Néa Michanióna, 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
Related Publications (1)
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.
PMID: 28186933DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Apostolos Tsapas
- Organization
- Aristotle University Thessaloniki
Study Officials
- PRINCIPAL INVESTIGATOR
Apostolos Tsapas, MD, MSc, PhD
Aristotle University Of Thessaloniki
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
May 20, 2013
First Posted
May 24, 2013
Study Start
May 1, 2013
Primary Completion
February 1, 2014
Study Completion
August 1, 2014
Last Updated
March 13, 2017
Results First Posted
March 13, 2017
Record last verified: 2017-01