N/A
Completed N=204
The Diabetes Medication Choice Cards Trial in Greece
Source: ClinicalTrials.gov NCT01861756 ↗Enrolled (actual)
204
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Overall Decisional Comfort (0-100, 100=no Conflict) — 82; 75.1 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Decisional Comfort (0-100, 100=no Conflict) |
82; 75.1 | — |
| SECONDARY Degree of Patient Knowledge About Available Treatment Alternatives |
— | — |
| SECONDARY Patient and Clinician Satisfaction With the Decision Making Process |
— | — |
| SECONDARY Adherence With Antihyperglycemic Regimens as Reported by the Patient Himself/Herself or Assessed Utilizing the Pharmacy Records |
— | — |
| SECONDARY Glycemic Control (HbA1c) |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT01861756). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.