Trial Outcomes & Findings for Diabetes Journey: An Adolescent Adherence Barriers Intervention (NCT NCT04404556)
NCT ID: NCT04404556
Last Updated: 2025-07-15
Results Overview
Stress and Burnout Scale - assesses frustration and feeling burned out by diabetes and its management. Score range from 1-5, with higher scores representing greater barriers.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
195 participants
Primary outcome timeframe
6-month follow-up
Results posted on
2025-07-15
Participant Flow
After participants were consented, there was a screening process. If participants were elevated on the BDA, they were eligible to be randomized. If they were not elevated, they screen failed. Of the 195 participants who were consented, n=13 screen failed and additional n=20 withdrew prior to randomization. Thus, only n=162 were randomized.
Participant milestones
| Measure |
Diabetes Journey
Diabetes Journey is a web-based intervention to address key adherence barriers. Participants randomized to this arm will first receive the mandatory Introduction and Problem-Solving Module. Based on their elevations on the Barriers to Diabetes Adherence measure, participants will receive up to 7 modules in total. Participants will navigate through the web-based theme park map and complete modules independently and then will have accompanying Zoom telehealth sessions with a therapist.
Diabetes Journey: Web-based telehealth intervention focused on adherence barriers and problem-solving
|
Enhanced Standard of Care
Participants randomized to Enhanced Standard of Care will receive general education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) from each site across 12-weeks. Content to address adherence barriers were modified and or newly developed for the Enhanced Standard of Care group via the T1DToolkit website.
Enhanced Standard of Care: General education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) will be provided.
|
|---|---|---|
|
Intervention
STARTED
|
97
|
65
|
|
Intervention
COMPLETED
|
80
|
61
|
|
Intervention
NOT COMPLETED
|
17
|
4
|
|
Post-Intervention
STARTED
|
82
|
62
|
|
Post-Intervention
COMPLETED
|
81
|
60
|
|
Post-Intervention
NOT COMPLETED
|
1
|
2
|
|
Follow-up 1
STARTED
|
81
|
62
|
|
Follow-up 1
COMPLETED
|
72
|
54
|
|
Follow-up 1
NOT COMPLETED
|
9
|
8
|
|
Follow-up 2
STARTED
|
63
|
50
|
|
Follow-up 2
COMPLETED
|
56
|
44
|
|
Follow-up 2
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
| Measure |
Diabetes Journey
Diabetes Journey is a web-based intervention to address key adherence barriers. Participants randomized to this arm will first receive the mandatory Introduction and Problem-Solving Module. Based on their elevations on the Barriers to Diabetes Adherence measure, participants will receive up to 7 modules in total. Participants will navigate through the web-based theme park map and complete modules independently and then will have accompanying Zoom telehealth sessions with a therapist.
Diabetes Journey: Web-based telehealth intervention focused on adherence barriers and problem-solving
|
Enhanced Standard of Care
Participants randomized to Enhanced Standard of Care will receive general education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) from each site across 12-weeks. Content to address adherence barriers were modified and or newly developed for the Enhanced Standard of Care group via the T1DToolkit website.
Enhanced Standard of Care: General education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) will be provided.
|
|---|---|---|
|
Intervention
Withdrawal by Subject
|
15
|
3
|
|
Intervention
Did not complete all intervention sessions
|
2
|
1
|
|
Post-Intervention
Missing Data
|
1
|
2
|
|
Follow-up 1
Withdrawal by Subject
|
5
|
1
|
|
Follow-up 1
Missing Data
|
4
|
7
|
|
Follow-up 2
Withdrawal by Subject
|
1
|
1
|
|
Follow-up 2
Missing Data
|
6
|
5
|
Baseline Characteristics
Diabetes Journey: An Adolescent Adherence Barriers Intervention
Baseline characteristics by cohort
| Measure |
Diabetes Journey
n=97 Participants
Diabetes Journey is a web-based intervention to address key adherence barriers. Participants randomized to this arm will first receive the mandatory Introduction and Problem-Solving Module. Based on their elevations on the Barriers to Diabetes Adherence measure, participants will receive up to 7 modules in total. Participants will navigate through the web-based theme park map and complete modules independently and then will have accompanying Zoom telehealth sessions with a therapist.
Diabetes Journey: Web-based telehealth intervention focused on adherence barriers and problem-solving
|
Enhanced Standard of Care
n=65 Participants
Participants randomized to Enhanced Standard of Care will receive general education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) from each site across 12-weeks. Content to address adherence barriers were modified and or newly developed for the Enhanced Standard of Care group via the T1DToolkit website.
Enhanced Standard of Care: General education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) will be provided.
|
Total
n=162 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.82 years
STANDARD_DEVIATION 1.49 • n=5 Participants
|
14.74 years
STANDARD_DEVIATION 1.72 • n=7 Participants
|
14.79 years
STANDARD_DEVIATION 1.58 • n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
91 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
86 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6-month follow-upStress and Burnout Scale - assesses frustration and feeling burned out by diabetes and its management. Score range from 1-5, with higher scores representing greater barriers.
Outcome measures
| Measure |
Diabetes Journey
n=72 Participants
Diabetes Journey is a web-based intervention to address key adherence barriers. Participants randomized to this arm will first receive the mandatory Introduction and Problem-Solving Module. Based on their elevations on the Barriers to Diabetes Adherence measure, participants will receive up to 7 modules in total. Participants will navigate through the web-based theme park map and complete modules independently and then will have accompanying Zoom telehealth sessions with a therapist.
Diabetes Journey: Web-based telehealth intervention focused on adherence barriers and problem-solving
|
Enhanced Standard of Care
n=54 Participants
Participants randomized to Enhanced Standard of Care will receive general education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) from each site across 12-weeks. Content to address adherence barriers were modified and or newly developed for the Enhanced Standard of Care group via the T1DToolkit website.
Enhanced Standard of Care: General education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) will be provided.
|
|---|---|---|
|
Barriers to Diabetes Adherence Questionnaire-Youth Report Stress/Burnout Subscale
|
2.36 score on a scale
Standard Deviation 0.90
|
2.31 score on a scale
Standard Deviation 1.05
|
PRIMARY outcome
Timeframe: 6-month follow-upTime Pressure and Planning Subscale - assesses the time and energy it takes to plan for diabetes self-management, including carrying supplies and making management decisions. Score range from 1-5, with higher scores representing greater barriers.
Outcome measures
| Measure |
Diabetes Journey
n=72 Participants
Diabetes Journey is a web-based intervention to address key adherence barriers. Participants randomized to this arm will first receive the mandatory Introduction and Problem-Solving Module. Based on their elevations on the Barriers to Diabetes Adherence measure, participants will receive up to 7 modules in total. Participants will navigate through the web-based theme park map and complete modules independently and then will have accompanying Zoom telehealth sessions with a therapist.
Diabetes Journey: Web-based telehealth intervention focused on adherence barriers and problem-solving
|
Enhanced Standard of Care
n=54 Participants
Participants randomized to Enhanced Standard of Care will receive general education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) from each site across 12-weeks. Content to address adherence barriers were modified and or newly developed for the Enhanced Standard of Care group via the T1DToolkit website.
Enhanced Standard of Care: General education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) will be provided.
|
|---|---|---|
|
Barriers to Diabetes Adherence Questionnaire - Youth Report Time Pressure/Planning Subscale
|
1.92 score on a scale
Standard Deviation 0.58
|
2.03 score on a scale
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: 6-month follow-upA blood test that measures the average blood sugar levels over the past two to three months.
Outcome measures
| Measure |
Diabetes Journey
n=63 Participants
Diabetes Journey is a web-based intervention to address key adherence barriers. Participants randomized to this arm will first receive the mandatory Introduction and Problem-Solving Module. Based on their elevations on the Barriers to Diabetes Adherence measure, participants will receive up to 7 modules in total. Participants will navigate through the web-based theme park map and complete modules independently and then will have accompanying Zoom telehealth sessions with a therapist.
Diabetes Journey: Web-based telehealth intervention focused on adherence barriers and problem-solving
|
Enhanced Standard of Care
n=49 Participants
Participants randomized to Enhanced Standard of Care will receive general education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) from each site across 12-weeks. Content to address adherence barriers were modified and or newly developed for the Enhanced Standard of Care group via the T1DToolkit website.
Enhanced Standard of Care: General education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) will be provided.
|
|---|---|---|
|
Hemoglobin A1C
|
8.06 percentage of glycosylated hemoglobin
Standard Deviation 1.72
|
7.98 percentage of glycosylated hemoglobin
Standard Deviation 1.67
|
SECONDARY outcome
Timeframe: 6-month follow-upTotal Quality of Life Scores range from 0-100, with higher scores indicating better quality of life
Outcome measures
| Measure |
Diabetes Journey
n=65 Participants
Diabetes Journey is a web-based intervention to address key adherence barriers. Participants randomized to this arm will first receive the mandatory Introduction and Problem-Solving Module. Based on their elevations on the Barriers to Diabetes Adherence measure, participants will receive up to 7 modules in total. Participants will navigate through the web-based theme park map and complete modules independently and then will have accompanying Zoom telehealth sessions with a therapist.
Diabetes Journey: Web-based telehealth intervention focused on adherence barriers and problem-solving
|
Enhanced Standard of Care
n=50 Participants
Participants randomized to Enhanced Standard of Care will receive general education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) from each site across 12-weeks. Content to address adherence barriers were modified and or newly developed for the Enhanced Standard of Care group via the T1DToolkit website.
Enhanced Standard of Care: General education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) will be provided.
|
|---|---|---|
|
Type 1 Diabetes and Life -Youth Report
|
65.84 score on a scale
Standard Deviation 14.71
|
65.82 score on a scale
Standard Deviation 18.32
|
SECONDARY outcome
Timeframe: 6-month follow-up% Time in Range for those on continuous glucose monitors.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6-month follow-up\# blood glucose checks per day
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6-month follow-up\# carbohydrate entries per day for insulin pump users
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6-month follow-upThe average of the frequency of insulin boluses delivered per day
Outcome measures
Outcome data not reported
Adverse Events
Diabetes Journey
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
Enhanced Standard of Care
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Diabetes Journey
n=97 participants at risk
Diabetes Journey is a web-based intervention to address key adherence barriers. Participants randomized to this arm will first receive the mandatory Introduction and Problem-Solving Module. Based on their elevations on the Barriers to Diabetes Adherence measure, participants will receive up to 7 modules in total. Participants will navigate through the web-based theme park map and complete modules independently and then will have accompanying Zoom telehealth sessions with a therapist.
Diabetes Journey: Web-based telehealth intervention focused on adherence barriers and problem-solving
|
Enhanced Standard of Care
n=65 participants at risk
Participants randomized to Enhanced Standard of Care will receive general education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) from each site across 12-weeks. Content to address adherence barriers were modified and or newly developed for the Enhanced Standard of Care group via the T1DToolkit website.
Enhanced Standard of Care: General education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) will be provided.
|
|---|---|---|
|
Psychiatric disorders
Increased suicidal ideation
|
0.00%
0/97 • ~9 months
|
1.5%
1/65 • Number of events 1 • ~9 months
|
Other adverse events
| Measure |
Diabetes Journey
n=97 participants at risk
Diabetes Journey is a web-based intervention to address key adherence barriers. Participants randomized to this arm will first receive the mandatory Introduction and Problem-Solving Module. Based on their elevations on the Barriers to Diabetes Adherence measure, participants will receive up to 7 modules in total. Participants will navigate through the web-based theme park map and complete modules independently and then will have accompanying Zoom telehealth sessions with a therapist.
Diabetes Journey: Web-based telehealth intervention focused on adherence barriers and problem-solving
|
Enhanced Standard of Care
n=65 participants at risk
Participants randomized to Enhanced Standard of Care will receive general education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) from each site across 12-weeks. Content to address adherence barriers were modified and or newly developed for the Enhanced Standard of Care group via the T1DToolkit website.
Enhanced Standard of Care: General education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) will be provided.
|
|---|---|---|
|
Psychiatric disorders
Psychological Complications
|
46.4%
45/97 • Number of events 73 • ~9 months
|
55.4%
36/65 • Number of events 54 • ~9 months
|
|
Injury, poisoning and procedural complications
Medical complications not related to type 1 diabetes
|
15.5%
15/97 • Number of events 17 • ~9 months
|
13.8%
9/65 • Number of events 10 • ~9 months
|
|
Endocrine disorders
Medical complications related to type 1 diabetes
|
13.4%
13/97 • Number of events 15 • ~9 months
|
6.2%
4/65 • Number of events 5 • ~9 months
|
|
Social circumstances
Social complication
|
1.0%
1/97 • Number of events 1 • ~9 months
|
0.00%
0/65 • ~9 months
|
|
Investigations
Regulatory Issue
|
0.00%
0/97 • ~9 months
|
1.5%
1/65 • Number of events 1 • ~9 months
|
Additional Information
Avani Modi, Ph.D.
Cincinnati Children's Hospital Medical Center
Phone: 513-636-4864
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place