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

NCT03855449 | Completed Results

• 2 other identifiers: STUDY001414601K01HL135472-01A1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Problem solving; Self-management; Education

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (2)

• Health Problem Solving Scores Outcomes

  18 weeks

• Diabetes Self -Care Behaviors-monitoring Blood Glucose Levels

  18 weeks

Study Arms (2)

eDECIDE Web-based Intervention Group

EXPERIMENTAL

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.

Behavioral: eDECIDE Web-based Intervention Group

DECIDE Traditional Group

ACTIVE COMPARATOR

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.

Behavioral: eDECIDE Web-based Intervention Group

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

DECIDE Traditional Group; eDECIDE Web-based Intervention Group

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• hr plasma glucose ≥ 200 mg/dL
• Glycosylated hemoglobin HbA1c ≥ to 6.5%
• Random plasma glucose ≥ 200 mg/dL

You may not qualify if:

• 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

Sponsors & Collaborators

• Wichita State University: collaborator
• University of Kansas Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Kansas Medical Center

Wichita, Kansas, 67214, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

Delayed start of pilot trial for the online intervention due to Coronavirus 2019 (COVID-19) impacted recruitment, thus leading to low number of subjects analyzed in both arms.

Results Point of Contact

• Title: Dr. Michelle Redmond
• Organization: University of Kansas Medical Center

mredmond@kumc.edu

316-293-1813

Study Officials

• Michelle L Redmond, PhD

  University of Kansas Medican Center Research Institute, Inc

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A single group will be recruited to go through the in-person DECIDE problem-solving curriculum

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 26, 2019
• Study Start: June 5, 2019
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: March 20, 2026
• Results First Posted: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)