A Task Analysis Study of DECIDE For African American Patients With Type 2 Diabetes

Part of paid clinical trials in Wichita, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT03855449
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • eDECIDE Web-based Intervention Group — BEHAVIORAL
    Will conduct 18 week in-person group sessions of the DECIDE curriculum with recruited volunteers. This is part 1 or phase I of the eventual pilot clinical trial. Participants will attend weekly group sessions to learn problem-solving skills and management of their diabetes. After the completion of the task analysis participants will be recruited for the eDECIDE web-based intervention

Study Details

The Decision-Making Education for Choices in Diabetes Every Day (DECIDE) program (copyrighted) was created by Dr. Felicia Hill-Briggs and is used by permission for the purpose of this pilot study. This problem-solving curriculum is used to help manage everyday problems when living with diabetes. The purpose of this project is to complete an in-depth review of the Decision-Making Education for Choices in Diabetes Every Day (DECIDE) curriculum, which is delivered in a group face-to-face setting. Using a task analysis process, the investigators will use the findings from the review to develop a web-site version that will be called eDECIDE for use with a community group in Kansas. Phase 3: will be a pilot clinical trial (2 Arm Study) which examines the use of the eDECIDE curriculum compared to the traditional DECIDE curriculum delivered to participants individually.

Key Dates

Start date
Jun 5, 2019
Status verified
Mar 2026
Primary completion
Oct 30, 2024
Completion
Oct 30, 2024

Study Design

Enrollment
36 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: eDECIDE Web-based Intervention Group
    Participants randomized to the eDECIDE arm will use the online version of the program through the eDECIDE study portal. Participants in this group will receive bi-weekly calls from their health coach to mark their progress with the program.
  • Active Comparator: DECIDE Traditional Group
    Participants randomized to the DECIDE group will receive a copy of the curriculum via mail and will be a self-study group where they go through the curriculum on their own with 4 calls from their health coach.

Primary Outcome Measure

Percentage of Glycated Hemoglobin Among Participants at Baseline and 18-week Follow-up [ Time Frame: Change in glycated hemoglobin (A1c) over time at baseline and 18-week post-intervention follow-up ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Kansas Medical CenterWichitaKansas67214-

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