Trial Outcomes & Findings for A Task Analysis Study of DECIDE For African American Patients With Type 2 Diabetes (NCT NCT03855449)
NCT ID: NCT03855449
Last Updated: 2026-03-20
Results Overview
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.
COMPLETED
NA
36 participants
Change in glycated hemoglobin (A1c) over time at baseline and 18-week post-intervention follow-up
2026-03-20
Participant Flow
Overall, 36 participants were recruited over three different phases of the study. Phase 1: Task Analysis Study- a total of 4 participants were recruited in year one of the study. Phase 2: Usability Testing Study- a total of 11 participants were recruited in years 2-3 of the study. Phase 3: Pilot Clinical Trial of eDECIDE- a total of 21 participants were recruited in year 4 of the study. In Phase 1 \& 2, no arms were assigned.
For Phase 1 (Task Analysis Study) and Phase 2 (Usability Study), no assignment or arm was given. All participants completed study task. No baseline measures were collected as in phase 3, the pilot study. Phase 1: Task Analysis Study- a total of 4 participants were recruited Phase 2: Usability Testing Study- a total of 11 participants were recruited Phase 3: Pilot Clinical Trial of eDECIDE- a total of 21 participants were recruited. Total participants from phase 1 thru 3 is 36. Phase 3 =21.
Participant milestones
| Measure |
eDECIDE Web-based Intervention Group/Arm
Participants randomized to the eDECIDE (Decision-Making Education for Choices in Diabetes Every Day) 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 (Decision-Making Education for Choices in Diabetes Every Day) 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
|
|---|---|---|
|
Phase 1, Task Analysis Study
STARTED
|
4
|
0
|
|
Phase 1, Task Analysis Study
COMPLETED
|
4
|
0
|
|
Phase 1, Task Analysis Study
NOT COMPLETED
|
0
|
0
|
|
Phase 2: Usability Testing Study
STARTED
|
11
|
0
|
|
Phase 2: Usability Testing Study
COMPLETED
|
11
|
0
|
|
Phase 2: Usability Testing Study
NOT COMPLETED
|
0
|
0
|
|
Phase 3, Pilot Clinical Trial
STARTED
|
11
|
10
|
|
Phase 3, Pilot Clinical Trial
COMPLETED
|
5
|
6
|
|
Phase 3, Pilot Clinical Trial
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
eDECIDE Web-based Intervention Group/Arm
Participants randomized to the eDECIDE (Decision-Making Education for Choices in Diabetes Every Day) 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 (Decision-Making Education for Choices in Diabetes Every Day) 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
|
|---|---|---|
|
Phase 3, Pilot Clinical Trial
Lost to Follow-up
|
6
|
4
|
Baseline Characteristics
BMI measures were not collected for Phase I and Phase II participants, thus 0 participants were analyzed.
Baseline characteristics by cohort
| Measure |
Phase 1: Task Analysis Study
n=4 Participants
Participants were recruited through community recruitment and word of mouth. During the task analysis participants went through the DECIDE curriculum for purposes of creating the website curriculum.
Participants in Phase 1 only had gender, race, and Diabetes status (yes or no) collected.
|
Phase II: Usability Testing
n=11 Participants
Participants were recruited through community recruitment and word of mouth to participate in the usability testing study of the eDECIDE website prior to the pilot clinical trial. Participants in Phase 2 only had gender, race, and Diabetes status (yes or no) collected.
|
eDECIDE Web-based Intervention Group
n=11 Participants
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.
|
DECIDE Traditional Group
n=10 Participants
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.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=4 Participants
|
7 Participants
n=11 Participants
|
9 Participants
n=11 Participants
|
8 Participants
n=10 Participants
|
26 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=4 Participants
|
4 Participants
n=11 Participants
|
2 Participants
n=11 Participants
|
2 Participants
n=10 Participants
|
10 Participants
n=36 Participants
|
|
Age, Continuous
|
49.5 years
n=4 Participants
|
59.8 years
n=11 Participants
|
59.63 years
n=11 Participants
|
60.70 years
n=10 Participants
|
59.71 years
n=36 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=4 Participants
|
8 Participants
n=11 Participants
|
9 Participants
n=11 Participants
|
8 Participants
n=10 Participants
|
29 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=4 Participants
|
3 Participants
n=11 Participants
|
2 Participants
n=11 Participants
|
2 Participants
n=10 Participants
|
7 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=4 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=4 Participants
|
11 Participants
n=11 Participants
|
11 Participants
n=11 Participants
|
10 Participants
n=10 Participants
|
36 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=4 Participants
|
11 Participants
n=11 Participants
|
11 Participants
n=11 Participants
|
10 Participants
n=10 Participants
|
36 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=4 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=4 Participants
|
11 Participants
n=11 Participants
|
11 Participants
n=11 Participants
|
10 Participants
n=10 Participants
|
36 Participants
n=36 Participants
|
|
BMI
|
—
|
—
|
33.30 kg/m^2
n=11 Participants • BMI measures were not collected for Phase I and Phase II participants, thus 0 participants were analyzed.
|
33.19 kg/m^2
n=10 Participants • BMI measures were not collected for Phase I and Phase II participants, thus 0 participants were analyzed.
|
33.19 kg/m^2
n=21 Participants • BMI measures were not collected for Phase I and Phase II participants, thus 0 participants were analyzed.
|
PRIMARY outcome
Timeframe: Change in glycated hemoglobin (A1c) over time at baseline and 18-week post-intervention follow-upPopulation: Only participants in Phase 3 (Randomized Pilot Clinical Trial) were assessed for primary clinical outcome of glycated hemoglobin. Primary clinical outcome on glycated hemoglobin among participants at baseline and 18-week follow-u. Randomized participants into the eDECIDE Intervention arm and the Traditional DECIDE arm at baseline. Only participants in phase 3 were again assessed for their health problem-solving skills and diabetes self-care at post-intervention 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.
Outcome measures
| Measure |
eDECIDE Web-based Intervention Group
n=11 Participants
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.
eDECIDE Web-based Intervention Group: 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
n=10 Participants
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.
eDECIDE Web-based Intervention Group: 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
|
|---|---|---|
|
Percentage of Glycated Hemoglobin Among Participants at Baseline and 18-week Follow-up
Follow-up
|
8.40 Percentage of glycated hemoglobin
Interval 6.0 to 8.8
|
7.35 Percentage of glycated hemoglobin
Interval 7.0 to 9.2
|
|
Percentage of Glycated Hemoglobin Among Participants at Baseline and 18-week Follow-up
Baseline
|
8.0 Percentage of glycated hemoglobin
Interval 6.9 to 15.02
|
7.40 Percentage of glycated hemoglobin
Interval 7.0 to 13.4
|
SECONDARY outcome
Timeframe: 18 weeksPopulation: Participants were again assessed for their health problem-solving skills and diabetes self-care at baseline and post-intervention follow-up. Only participants in Phase 3 (Pilot Clinical Trial) were assessed on this secondary outcome measure.
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.
Outcome measures
| Measure |
eDECIDE Web-based Intervention Group
n=11 Participants
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.
eDECIDE Web-based Intervention Group: 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
n=10 Participants
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.
eDECIDE Web-based Intervention Group: 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
|
|---|---|---|
|
Health Problem Solving Scores Outcomes
Baseline Health Problem-solving
|
22.54 score on a scale
Interval 21.52 to 24.22
|
17.9 score on a scale
Interval 16.7 to 21.99
|
|
Health Problem Solving Scores Outcomes
Follow-up Health Problem-solving
|
22.96 score on a scale
Interval 22.32 to 24.03
|
24.02 score on a scale
Interval 20.89 to 25.05
|
SECONDARY outcome
Timeframe: 18 weeksPopulation: Only participants in phase 3 (pilot clinical trial) were assessed for Diabetes Self -Care Behaviors
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.
Outcome measures
| Measure |
eDECIDE Web-based Intervention Group
n=11 Participants
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.
eDECIDE Web-based Intervention Group: 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
n=10 Participants
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.
eDECIDE Web-based Intervention Group: 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
|
|---|---|---|
|
Diabetes Self -Care Behaviors-monitoring Blood Glucose Levels
Baseline
|
7 Participants
|
6 Participants
|
|
Diabetes Self -Care Behaviors-monitoring Blood Glucose Levels
Follow-up
|
5 Participants
|
3 Participants
|
Adverse Events
Intervention Arm/eDECIDE Group
Active Comparator: DECIDE Traditional Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Michelle Redmond
University of Kansas Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place