Diabetes Mellitus, Type 2
Conditions
Keywords
Patient Decision Aid, Shared Decision Making
Brief summary
The objectives of this study are to compare measurements in knowledge of decision options, support for decision making, uncertainly in decision making, and clarity of values important to decision making among two groups of type 2 diabetes patients, those who receive a Patient Decision Aid and those who receive usual care.
Detailed description
This study uses a randomized, controlled trial design to compare knowledge of decision options, support for decision making, uncertainly in decision making, and clarity of values important to decision making among patients with uncontrolled type 2 diabetes who are only taking metformin medication. The intervention is a Patient Decision Aid (PDA) video delivered via the internet.
Interventions
BEHAVIORALUse of a PDA to assist shared decision making
Sponsors
EPI-Q
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Type 2 diabetes 2. Age 18 or older 3. English speaking 4. Currently taking metformin 5. Inadequate glycemic control in the opinion of the investigator 6. Is considering additional medication options on the advice of their physician 7. Can provide a valid email address 8. Access to the internet and able to read and respond to internet questionnaires
Exclusion criteria
1. Participation in a clinical trial of a diabetes medication within 1 year 2. Currently taking more than two (2) medications for diabetes 3. Has been exposed to diabetes medications from more than three (3) drug classes 4. Adults unable to consent 5. Individuals who are not yet adults (infants, children, teenagers) 6. Pregnant women 7. Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge score | 6 weeks | The primary endpoint for this investigation is the knowledge total score at final followup 4- 6 weeks after randomization between the PDA versus usual care groups. Questions are about available treatments and specific to the information on medication options available to people with type 2 diabetes when metformin alone does not achieve adequate glycemic control. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decisional conflict | 6 weeks | Measured by using the Decisional Conflict Scale (DCS). Scale will measure domains including: (1) uncertainty in choosing among alternatives; (2) modifiable factors contributing to uncertainty such as feeling uninformed, unclear about values and unsupported in decision making; and (3) perceived quality of decision making. Global decision conflict score and perceived effective decision sub-score will be summarized descriptively following decision and will be compared between arms. Sub-scores are: Uncertainty, Informed, Values clarity, and Support. |
Countries
United States
Outcome results
None listed