Trial Outcomes & Findings for The Diabetes Medication Choice Cards Trial in Greece (NCT NCT01861756)
NCT ID: NCT01861756
Last Updated: 2017-03-13
Results Overview
Quality of the decision making process assessed by means of the Decisional Conflict Scale
COMPLETED
NA
204 participants
Day 1
2017-03-13
Participant Flow
Participant milestones
| Measure |
Diabetes Medication Choice Decision Aid
|
Usual Care
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
103
|
|
Overall Study
COMPLETED
|
88
|
85
|
|
Overall Study
NOT COMPLETED
|
13
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Diabetes Medication Choice Cards Trial in Greece
Baseline characteristics by cohort
| Measure |
Diabetes Medication Choice Decision Aid
n=101 Participants
|
Usual Care
n=103 Participants
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.8 years
STANDARD_DEVIATION 11 • n=99 Participants
|
64.4 years
STANDARD_DEVIATION 11.3 • n=107 Participants
|
65.1 years
STANDARD_DEVIATION 11.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
116 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
|
Region of Enrollment
Greece
|
101 participants
n=99 Participants
|
103 participants
n=107 Participants
|
204 participants
n=206 Participants
|
|
Type 2 diabetes duration
<5 years
|
27 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Type 2 diabetes duration
5 - 10 years
|
20 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Type 2 diabetes duration
>10 years
|
53 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
|
Type 2 diabetes duration
missing data
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
HbA1c
|
8.4 %
STANDARD_DEVIATION 0.8 • n=99 Participants
|
8.5 %
STANDARD_DEVIATION 0.8 • n=107 Participants
|
8.5 %
STANDARD_DEVIATION 0.8 • n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1Quality of the decision making process assessed by means of the Decisional Conflict Scale
Outcome measures
| Measure |
Diabetes Medication Choice Decision Aid
n=101 Participants
|
Usual Care
n=103 Participants
|
|---|---|---|
|
Overall Decisional Comfort (0-100, 100=no Conflict)
|
82 units on a scale
Interval 70.0 to 94.0
|
75.1 units on a scale
Interval 61.0 to 89.2
|
SECONDARY outcome
Timeframe: Day 1Patients will complete a 6-item questionnaire addressing general knowledge about type 2 diabetes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1Patient 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 and 6 months after patient initial encounterOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 and 6 months after patient initial encounterOutcome measures
Outcome data not reported
Adverse Events
Diabetes Medication Choice Decision Aid
Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place