Validation of a Patient Decision Aid for Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alicia Shillington, EPI-Q
ClinicalTrials.gov Identifier:
NCT02110979
First received: April 4, 2014
Last updated: August 5, 2015
Last verified: August 2015
  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: 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 EPI-Q:

Primary Outcome Measures:
  • Knowledge score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02110979

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

No publications provided

Responsible Party: Alicia Shillington, Executive Vice President, EPI-Q
ClinicalTrials.gov Identifier: NCT02110979     History of Changes
Other Study ID Numbers: 70-1036-015
Study First Received: April 4, 2014
Last Updated: August 5, 2015
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 01, 2015