Clinical trial NCT01861756: The Diabetes Medication Choice Cards Trial in Greece
Official title: The Diabetes Medication Choice Cards Trial in Greece
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Shared Decision Making
Decision Aids
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: European Foundation for the Study of Diabetes
name: Mayo Clinic
First posted: 2013-05-24
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Overall Decisional Comfort (0-100, 100=no Conflict)
timeFrame: Day 1
Secondary outcomes:
measure: Degree of Patient Knowledge About Available Treatment Alternatives
timeFrame: Day 1
measure: Patient and Clinician Satisfaction With the Decision Making Process
timeFrame: Day 1
measure: Adherence With Antihyperglycemic Regimens as Reported by the Patient Himself/Herself or Assessed Utilizing the Pharmacy Records
timeFrame: 3 and 6 months after patient initial encounter
measure: Glycemic Control (HbA1c)
timeFrame: 3 and 6 months after patient initial encounter
Other outcomes:
Locations:
city: Piraeus
country: Greece
facility: Tzanio General Hospital
state: Attiki
city: Nea Michaniona
country: Greece
facility: Nea Michaniona Health Center
state: Thessaloniki
city: Neapoli
country: Greece
facility: Private practice
state: Thessaloniki
city: Thermi
country: Greece
facility: Thermi S.A.
state: Thessaloniki
city: Alexandroupoli
country: Greece
facility: Alexandroupoli University Hospital
city: Athens
country: Greece
facility: NIMTS Military Hospital
city: Athens
country: Greece
facility: Polikliniki General Hospital
city: Serres
country: Greece
facility: Private practice
Study officials:
affiliation: Aristotle University Of Thessaloniki
name: Apostolos Tsapas, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.