Validation of a Patient Decision Aid for Type 2 Diabetes
1 other identifier
interventional
200
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Apr 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 4, 2014
CompletedFirst Posted
Study publicly available on registry
April 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedAugust 7, 2015
August 1, 2015
1.1 years
April 4, 2014
August 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Decisional conflict
6 weeks
Study Arms (2)
PDA
EXPERIMENTALSubjects receive an internet-based patient decision aid video. The PDA is viewed outside of the doctor's office via a personal computer in preparation for regularly scheduled face to face interaction between patients and clinicians.
Usual care
NO INTERVENTIONPatients receive usual care as determined by their clinician.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Prisoners
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EPI-Qlead
Study Sites (2)
EPI-Q Inc
Oak Brook, Illinois, 60523, United States
EPI-Q
Oak Brook, Illinois, 60523, United States
Related Publications (1)
Bailey RA, Pfeifer M, Shillington AC, Harshaw Q, Funnell MM, VanWingen J, Col N. Effect of a patient decision aid (PDA) for type 2 diabetes on knowledge, decisional self-efficacy, and decisional conflict. BMC Health Serv Res. 2016 Jan 14;16:10. doi: 10.1186/s12913-016-1262-4.
PMID: 26762150DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alicia Shillington, PhD
EPI-Q
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Executive Vice President
Study Record Dates
First Submitted
April 4, 2014
First Posted
April 10, 2014
Study Start
April 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
August 7, 2015
Record last verified: 2015-08