Validation of a Patient Decision Aid for Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Validation of a Patient Decision Aid for Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02110979
• Other study ID #: 70-1036-015
• Status: Completed
• Phase: N/A
• First received: April 4, 2014
• Last updated: August 5, 2015
• Start date: April 2014
• Est. completion date: May 2015

Study information

• Verified date: August 2015
• Source: EPI-Q
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Use of a PDA to assist shared decision making

Locations

Country	Name	City	State
United States	EPI-Q	Oak Brook	Illinois
United States	EPI-Q Inc	Oak Brook	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
EPI-Q

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge score	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.	6 weeks	No
Secondary	Decisional conflict	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.	6 weeks	No