Trial record 20 of 1018 for:    Open Studies | "Diabetes Mellitus, Type 2"

Validation of a Patient Decision Aid for Type 2 Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by EPI-Q
Sponsor:
Information provided by (Responsible Party):
Alicia Shillington, EPI-Q
ClinicalTrials.gov Identifier:
NCT02110979
First received: April 4, 2014
Last updated: July 28, 2014
Last verified: July 2014
  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
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (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

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. Inadequate glycemic control on metformin alone in the opinion of the investigator
  5. Are considering additional medication options on the advice of their physician
  6. Access to the internet and able to read and respond to internet questionnaires
  7. Access to email and able to complete surveys online

Exclusion Criteria:

  1. Current or past participation in a clinical trial
  2. Prior exposure to an antidiabetic agent other than metformin
  3. Already taking an additional antidiabetic drug in addition to metformin
  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

Contacts
Contact: Alicia Shillington, PhD 630-605-2393 alicia.shillington@epi-q.com

Locations
United States, Illinois
EPI-Q Not yet recruiting
Oak Brook, Illinois, United States, 60523
Contact: Alicia Shillington, PhD    630-605-2393    alicia.shillington@epi-q.com   
Principal Investigator: Alicia Shillington, PhD         
EPI-Q Inc Recruiting
Oak Brook, Illinois, United States, 60523
Contact: Alicia Shillington, PhD    630-570-5505    alicia.shillington@epi-q.com   
Principal Investigator: Alicia Shillington, PhD         
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: July 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on August 21, 2014