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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Task Analysis Intervention Group
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 2 focused on measuring Problem solving, Self-management, Education

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • African American
  • English speaking
  • Access to the Internet daily
  • Reading level of at least 5th grade
  • Diagnosis of Type 2 Diabetes per one of the following

    1. Fasting blood glucose ≥ to 126 mg/dL
    2. 2 hr plasma glucose ≥ 200 mg/dL
    3. Glycosylated hemoglobin HbA1c ≥ to 6.5%
    4. Random plasma glucose ≥ 200 mg/dL

Exclusion Criteria:

  • Glycosylated hemoglobin HbA1c ≤ 7.0
  • Pregnancy
  • Severe visual or hearing impairment or any existing condition that would limit or hinder one's ability to use the Internet
  • Dementia
  • Use of supplemental oxygen
  • Chest pain or angina
  • Prior lower extremity amputation
  • A diagnosis of a life threatening malignancy within the past year

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Task Analysis Intervention Group

Arm Description

DECIDE problem-solving curriculum will be delivered in a group setting.

Outcomes

Primary Outcome Measures

Task Analysis study process chart
First output of the task analysis is a process chart of conducting the DECIDE program, using video tapped sessions of DECIDE
Task Analysis Wireframe Development part 1
Second output of the task analysis is a task flow diagram of facilitation and participant responses using case scenarios by user group.
Task Analysis Wireframe Development part 2
Third output of the task analysis is a task decomposition table of the DECIDE curriculum, breaking down the task/actions of facilitator and participant into smaller task for replicating on the website

Secondary Outcome Measures

Full Information

First Posted
February 20, 2019
Last Updated
December 14, 2021
Sponsor
University of Kansas Medical Center
Collaborators
Wichita State University, National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03855449
Brief Title
A Task Analysis Study of DECIDE For African American Patients With Type 2 Diabetes
Acronym
eDECIDE
Official Title
Web-Based Problem Solving Self-Management Program for African Americans With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 5, 2019 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
January 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center
Collaborators
Wichita State University, National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The DECIDE program is a problem-solving curriculum 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.
Detailed Description
The Task Analysis study of the DECIDE program is phase I (part 1) of a three-part study. Part 2 is usability testing and Part 3 is the pilot clinical trial. For part 1, a single group will receive the DECIDE intervention program as investigators conduct a task analysis of DECIDE in preparation for building the web-based version (eDECIDE). This web-based version will be used for part 3 of the study, which will be the pilot clinical trial (eDECIDE). Self-management is important for persons with type 2 diabetes for glycemic control. When diabetes is uncontrolled, it is important to get back in control in order to decrease further health complications. New ways of delivering self-management that improve access to treatment are needed. This study will help provide background information on any potential problems and or benefit of using web-based and mobile phone applications (mHealth) for diabetes self-management. In addition, this study will help researchers at University of Kansas School of Medicine create a web-based version of the in-person DECIDE program, known as eDECIDE. Data gathered from the in-person DECIDE group sessions will be used to create a series of events for designing a web-based copy based on several task (current study). Therefore, this study is known as a task analysis. Task Analysis: This entails documenting observations of an existing system, sequence of tasks, and information flows. High-level tasks are divided into subtasks and operations. Informational sources required in each subtask are also recorded. This technique is a critical step in any software development process to ensure a basic understanding of user needs and requirements necessary for optimal learning. It also provides a perspective on individual differences across patients. Understanding this workflow is critical and will serve as the basis for developing eDECIDE. For the task analysis up to 8 individuals will be recruited to take part in the in-person DECIDE problem-solving curriculum (task analysis), the information learned in the task analysis will help build and test (usability testing) the eDECIDE website, which are both integral to the pilot clinical trial (part 3) which will take place last. PROCEDURES The current study will administer the DECIDE curriculum to a single group, examine responses, build the website, and then prepare for implementing the pilot clinical trial. The information gathered from this study will provide information about barriers to problem solving for diabetes self-management and perceptions of using a web-based diabetes problem-solving format. Participants who meet eligibility criteria will take part in 9-weekly sessions on diabetes self-management and problem-solving techniques. The sessions will be recorded by audio and video tape. All audio and video taped recordings will be used to help create the web-based version of DECIDE, known as eDECIDE. All and any personal information that is recorded by audio tape will be removed when transcribing the audio recordings. All personal information such as name and face will be removed and blurred if video recording clips are used in an academic or conference meeting setting. Other personal identifiable information such as date of birth, address, or telephone number will be removed when transcribing and you will be identified by participant id number. The researcher will ask participants questions about their diabetes self-management behaviors; go over problem-solving techniques, and self-management skills. The recordings of the focus group sessions will be destroyed 12 months after publication of the research results. Task Analysis and usability testing Procedures: Using information gathered from the task analysis, the research team will develop a wire frame prototype of eDECIDE. A benefit of the prototype is to have a layout of the interface without the distraction of color or visual elements that would normally be a part of the actual webpages. Once the prototype of the website design is complete, investigators will conduct usability testing (part 2) to assess the efficiency, ease-of-use, and user satisfaction based on participant feedback. Participant feedback is collected via web camera and online questionnaires. Objective data are collected via logging software designed for usability testing. Usability testing is a step-by-step process conducted several times throughout the design and development process. Results from each test are used to make design recommendations for the eDECIDE website. Once usability testing is complete, the pilot clinical trial (part 3) of eDECIDE will begin. Our long-term goal is to understand how problem-solving skills training (PSST), delivered using web-based and mobile phone technology, can improve diabetes self-management in community populations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Problem solving, Self-management, Education

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A single group will be recruited to go through the in-person DECIDE problem-solving curriculum
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Task Analysis Intervention Group
Arm Type
Other
Arm Description
DECIDE problem-solving curriculum will be delivered in a group setting.
Intervention Type
Behavioral
Intervention Name(s)
Task Analysis Intervention Group
Intervention Description
Will conduct 9 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.
Primary Outcome Measure Information:
Title
Task Analysis study process chart
Description
First output of the task analysis is a process chart of conducting the DECIDE program, using video tapped sessions of DECIDE
Time Frame
15 weeks
Title
Task Analysis Wireframe Development part 1
Description
Second output of the task analysis is a task flow diagram of facilitation and participant responses using case scenarios by user group.
Time Frame
15 weeks
Title
Task Analysis Wireframe Development part 2
Description
Third output of the task analysis is a task decomposition table of the DECIDE curriculum, breaking down the task/actions of facilitator and participant into smaller task for replicating on the website
Time Frame
15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: African American English speaking Access to the Internet daily Reading level of at least 5th grade Diagnosis of Type 2 Diabetes per one of the following Fasting blood glucose ≥ to 126 mg/dL 2 hr plasma glucose ≥ 200 mg/dL Glycosylated hemoglobin HbA1c ≥ to 6.5% Random plasma glucose ≥ 200 mg/dL Exclusion Criteria: Glycosylated hemoglobin HbA1c ≤ 7.0 Pregnancy Severe visual or hearing impairment or any existing condition that would limit or hinder one's ability to use the Internet Dementia Use of supplemental oxygen Chest pain or angina Prior lower extremity amputation A diagnosis of a life threatening malignancy within the past year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle L Redmond, PhD
Organizational Affiliation
University of Kansas Medican Center Research Institute, Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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