Validation of a Patient Decision Aid for Type 2 Diabetes
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- EPI-Q
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Knowledge score
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Alicia Shillington
Executive Vice President
EPI-Q
Eligibility Criteria
Inclusion Criteria
- •Type 2 diabetes
- •Age 18 or older
- •English speaking
- •Currently taking metformin
- •Inadequate glycemic control in the opinion of the investigator
- •Is considering additional medication options on the advice of their physician
- •Can provide a valid email address
- •Access to the internet and able to read and respond to internet questionnaires
Exclusion Criteria
- •Participation in a clinical trial of a diabetes medication within 1 year
- •Currently taking more than two (2) medications for diabetes
- •Has been exposed to diabetes medications from more than three (3) drug classes
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
Outcomes
Primary Outcomes
Knowledge score
Time Frame: 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 Outcomes
- Decisional conflict(6 weeks)