We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Validation of a Patient Decision Aid for Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02110979
First Posted: April 10, 2014
Last Update Posted: August 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alicia Shillington, EPI-Q
  Purpose
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.

Condition Intervention
Diabetes Mellitus, Type 2 Behavioral: Use of a PDA to assist shared decision making

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Validation of a Patient Decision Aid for Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Alicia Shillington, EPI-Q:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Decisional conflict [ Time Frame: 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.


Estimated Enrollment: 200
Study Start Date: April 2014
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PDA
Subjects 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.
Behavioral: Use of a PDA to assist shared decision making
Other Name: Patient Decision Aid
No Intervention: Usual care
Patients receive usual care as determined by their clinician.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02110979


Locations
United States, Illinois
EPI-Q Inc
Oak Brook, Illinois, United States, 60523
EPI-Q
Oak Brook, Illinois, United States, 60523
Sponsors and Collaborators
EPI-Q
Investigators
Principal Investigator: Alicia Shillington, PhD EPI-Q
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alicia Shillington, Executive Vice President, EPI-Q
ClinicalTrials.gov Identifier: NCT02110979     History of Changes
Other Study ID Numbers: 70-1036-015
First Submitted: April 4, 2014
First Posted: April 10, 2014
Last Update Posted: August 7, 2015
Last Verified: August 2015

Keywords provided by Alicia Shillington, EPI-Q:
Patient Decision Aid
Shared Decision Making

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases