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Diabetes Mellitus, Type 2eDECIDENCT03855449

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

A study testing eDECIDE Web-based Intervention Group in people with Diabetes Mellitus, Type 2, run by University of Kansas Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 16 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
eDECIDE Web-based Intervention Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
5 Jun 2019to 30 Oct 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 2 hr plasma glucose ≥ 200 mg/dL
  • Glycosylated hemoglobin HbA1c ≥ to 6.5%
  • Random plasma glucose ≥ 200 mg/dL

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Kansas Medical Center

    Wichita, Kansas, 67214

Other trials in United States

About this study

Official title: Web-Based Problem Solving Self-Management Program for African Americans With Type 2 Diabetes

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.

Read the detailed description

The Task Analysis study of the DECIDE program is phase I (part 1) of a three-part study. Phase II (Part 2) is usability testing, and Phase 3 (Part 3) is the pilot clinical trial. For phase 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). In Phase 1, participants will go through the curriculum and will be video recorded to help mimic what should be on the eventual eDECIDE website. One phase 1 is completed a usability testing study will be conducted, which is phase II and involves getting feedback from participants on the actual use of the eDECIDE wireframe prototype through recorded interviews. This web-based version will be used for Phase 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.

Phase II- 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 (phase II/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 (phase III/ 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.

Currently Recruiting: Clinical Trial Phase of eDECIDE: Plot 2-Arm Study:

Intervention arm: eDECIDE Online Curriculum Comparison arm: DECIDE Traditional Curriculum delivered one/on/one (Self-Study).

Will recruit at total of 40-70 participants Primary outcome A1c Secondary outcomes: goal setting, problem-solving, feasibility of use for eDECIDE online, satisfaction with eDECIDE online.

Being tested
eDECIDE Web-based Intervention Group
Keywords
Problem solving, Self-management, Education
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • eDECIDE Web-based Intervention GroupBehavioural

    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 groups in NCT03855449
Study groupRoleWhat they receive
eDECIDE Web-based Intervention GroupExperimentalParticipants 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.
Receives: Behavioral: eDECIDE Web-based Intervention Group
DECIDE Traditional GroupActive comparatorParticipants 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.
Receives: Behavioral: eDECIDE Web-based Intervention Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Glycated Hemoglobin Among Participants at Baseline and 18-week Follow-up

    The primary outcome of interest is HbA1c (glycated hemoglobin) measurement in the traditional DECIDE (control) group and eDECIDE (intervention) group. A .5% change in HbA1c has been considered clinically meaningful.

    Measured: Change in glycated hemoglobin (A1c) over time at baseline and 18-week post-intervention follow-up

Secondary outcomes (2)
  1. Health Problem Solving Scores Outcomes

    Secondary outcomes on scores on the health problem-solving scale which looks at applying the process of recognizing and identifying problems, generating solutions, and making decisions to surmount specific barriers to completing self-management tasks and diabetes self-care behaviors (measuring) frequency and of self -management behaviors. The HPSS scale scores range from 4 (possible minimum score) to 28 (possible max score).

    Health Problem-Solving Scale (HPSS), higher scores indicate more effective problem-solving skill. There are seven subscales (Likert-scale is from zero to four and the mean scores from each subscale were summed and then an average was derived for the total score. Outcome measure data reflects the total problem solving score by arm at baseline and follow-up.

    Measured: 18 weeks

  2. Diabetes Self -Care Behaviors-monitoring Blood Glucose Levels

    Secondary outcomes on scores on diabetes self-care behaviors specifically checking blood glucose level (blood sugar) away from clinic office. Count of participants who checked blood sugar levels daily (at least 5 or more days a week).

    Scale used, Diabetes Self-care behaviors- scale ask frequency of days.

    Measured: 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2019
  2. Study start5 Jun 2019
  3. Primary completion30 Oct 2024
  4. Study completion30 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
A single group will be recruited to go through the in-person DECIDE problem-solving curriculum
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03855449
Sponsor's protocol ID
STUDY00141460
Other IDs
1K01HL135472-01A1
Acronym
eDECIDE
Status last verified
Mar 2026
First submitted
20 Feb 2019
Last updated
20 Mar 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing eDECIDE Web-based Intervention Group in people with Diabetes Mellitus, Type 2, run by University of Kansas Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.

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