Trial Outcomes & Findings for Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth (3Ms) (NCT NCT03168867)
NCT ID: NCT03168867
Last Updated: 2023-04-18
Results Overview
Hemoglobin A1c (HbA1c)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
149 participants
Primary outcome timeframe
Baseline, 6, 13 and 18 month follow-up
Results posted on
2023-04-18
Participant Flow
Participant milestones
| Measure |
Standard Educational Care Control
Participants in the standard educational control group received education regarding type 1 diabetes management during their routine clinic visits. Education was consistent with the standard care provided by each of the study sites.
|
The 3Ms Intervention + Standard Educational Care
The 3Ms was a brief e-health intervention delivered via an internet-based software application (CIAS) that incorporated principles of Motivational Interviewing. The goal of The 3Ms was to provide psychoeducation regarding the value of daily parental supervision of adolescent diabetes management and increase the primary caregiver's motivation to supervise adolescents' daily diabetes management. The intervention consisted of three brief 10-15 minute sessions delivered on a tablet computer during routine diabetes clinic appointments.
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
75
|
|
Overall Study
COMPLETED
|
73
|
70
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
Reasons for withdrawal
| Measure |
Standard Educational Care Control
Participants in the standard educational control group received education regarding type 1 diabetes management during their routine clinic visits. Education was consistent with the standard care provided by each of the study sites.
|
The 3Ms Intervention + Standard Educational Care
The 3Ms was a brief e-health intervention delivered via an internet-based software application (CIAS) that incorporated principles of Motivational Interviewing. The goal of The 3Ms was to provide psychoeducation regarding the value of daily parental supervision of adolescent diabetes management and increase the primary caregiver's motivation to supervise adolescents' daily diabetes management. The intervention consisted of three brief 10-15 minute sessions delivered on a tablet computer during routine diabetes clinic appointments.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
Baseline Characteristics
Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth (3Ms)
Baseline characteristics by cohort
| Measure |
Standard Educational Care Control
n=74 Participants
Participants in the standard educational control group received education regarding type 1 diabetes management during their routine clinic visits. Education was consistent with the standard care provided by each of the study sites.
|
The 3Ms Intervention + Standard Educational Care
n=75 Participants
The 3Ms was a brief e-health intervention delivered via an internet-based software application (CIAS) that incorporated principles of Motivational Interviewing. The goal of The 3Ms was to provide psychoeducation regarding the value of daily parental supervision of adolescent diabetes management and increase the primary caregiver's motivation to supervise adolescents' daily diabetes management. The intervention consisted of three brief 10-15 minute sessions delivered on a tablet computer during routine diabetes clinic appointments.
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.7 years
STANDARD_DEVIATION 1.5 • n=93 Participants
|
13.1 years
STANDARD_DEVIATION 1.8 • n=4 Participants
|
13.4 years
STANDARD_DEVIATION 1.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
86 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
63 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black
|
74 Participants
n=93 Participants
|
75 Participants
n=4 Participants
|
149 Participants
n=27 Participants
|
|
Hemoglobin A1c
|
11.5 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 2.8 • n=93 Participants
|
11.5 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 2.7 • n=4 Participants
|
11.5 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 2.7 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6, 13 and 18 month follow-upPopulation: The analyses were intent-to-treat. All randomized participants were included in the analyses
Hemoglobin A1c (HbA1c)
Outcome measures
| Measure |
Standard Educational Care Control
n=74 Participants
Participants in the standard educational control group received education regarding type 1 diabetes management during their routine clinic visits. Education was consistent with the standard care provided by each of the study sites.
|
The 3Ms Intervention + Standard Educational Care
n=75 Participants
The 3Ms was a brief e-health intervention delivered via an internet-based software application (CIAS) that incorporated principles of Motivational Interviewing. The goal of The 3Ms was to provide psychoeducation regarding the value of daily parental supervision of adolescent diabetes management and increase the primary caregiver's motivation to supervise adolescents' daily diabetes management. The intervention consisted of three brief 10-15 minute sessions delivered on a tablet computer during routine diabetes clinic appointments.
|
|---|---|---|
|
Glycemic Control
Baseline
|
11.51 percentage of glycosylated hemoglobin
Standard Deviation 2.8
|
11.48 percentage of glycosylated hemoglobin
Standard Deviation 2.7
|
|
Glycemic Control
6 month follow-up
|
11.55 percentage of glycosylated hemoglobin
Standard Deviation 2.7
|
11.14 percentage of glycosylated hemoglobin
Standard Deviation 2.6
|
|
Glycemic Control
13 month follow-up
|
11.47 percentage of glycosylated hemoglobin
Standard Deviation 2.9
|
11.09 percentage of glycosylated hemoglobin
Standard Deviation 2.7
|
|
Glycemic Control
18 month follow-up
|
11.47 percentage of glycosylated hemoglobin
Standard Deviation 2.9
|
10.76 percentage of glycosylated hemoglobin
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 13 months, and 18 monthsGlucose Meter (frequency of testing)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 months, 13 months, and 18 monthsDiabetes Management Scale (DMS)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 months, 13 months, and 18 monthsThe Parental Monitoring of Diabetes Care-Revised (PMDC-R)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 months, 13 months, and 18 monthsDiabetes Family Conflict Scale (DFCS-R)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 months, 13 months, and 18 monthsPatient Reported Outcomes Measurement Information System (PROMIS)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 months, 13 months, and 18 monthsBehavior Rating Inventory of Executive Function (BRIEF)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 months, 13 months, and 18 monthsEuroQol five-dimensional (EQ-5D)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 months, 13 months, and 18 monthsProblem Areas in Diabetes (PAID)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 months, 13 months, and 18 monthsConfusion, Hubbub, and Order Scale (CHAOS)
Outcome measures
Outcome data not reported
Adverse Events
Standard Educational Care Control
Serious events: 29 serious events
Other events: 29 other events
Deaths: 0 deaths
The 3Ms Intervention + Standard Educational Care
Serious events: 24 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Educational Care Control
n=74 participants at risk
Participants in the standard educational control group received education regarding type 1 diabetes management during their routine clinic visits. Education was consistent with the standard care provided by each of the study sites.
|
The 3Ms Intervention + Standard Educational Care
n=75 participants at risk
The 3Ms was a brief e-health intervention delivered via an internet-based software application (CIAS) that incorporated principles of Motivational Interviewing. The goal of The 3Ms was to provide psychoeducation regarding the value of daily parental supervision of adolescent diabetes management and increase the primary caregiver's motivation to supervise adolescents' daily diabetes management. The intervention consisted of three brief 10-15 minute sessions delivered on a tablet computer during routine diabetes clinic appointments.
|
|---|---|---|
|
Endocrine disorders
Diabetic ketoacidosis
|
18.9%
14/74 • Number of events 22 • 1 year, 6 months
|
14.7%
11/75 • Number of events 17 • 1 year, 6 months
|
|
Surgical and medical procedures
New Non-diabetes-Related Health Problem
|
2.7%
2/74 • Number of events 2 • 1 year, 6 months
|
4.0%
3/75 • Number of events 4 • 1 year, 6 months
|
|
Endocrine disorders
Blood glucose less than 50 mg/dL
|
16.2%
12/74 • Number of events 16 • 1 year, 6 months
|
13.3%
10/75 • Number of events 10 • 1 year, 6 months
|
|
Endocrine disorders
Worsening Diabetes-Related Health Problem
|
13.5%
10/74 • Number of events 14 • 1 year, 6 months
|
8.0%
6/75 • Number of events 6 • 1 year, 6 months
|
|
Psychiatric disorders
New Psychiatric Problem
|
0.00%
0/74 • 1 year, 6 months
|
1.3%
1/75 • Number of events 1 • 1 year, 6 months
|
Other adverse events
| Measure |
Standard Educational Care Control
n=74 participants at risk
Participants in the standard educational control group received education regarding type 1 diabetes management during their routine clinic visits. Education was consistent with the standard care provided by each of the study sites.
|
The 3Ms Intervention + Standard Educational Care
n=75 participants at risk
The 3Ms was a brief e-health intervention delivered via an internet-based software application (CIAS) that incorporated principles of Motivational Interviewing. The goal of The 3Ms was to provide psychoeducation regarding the value of daily parental supervision of adolescent diabetes management and increase the primary caregiver's motivation to supervise adolescents' daily diabetes management. The intervention consisted of three brief 10-15 minute sessions delivered on a tablet computer during routine diabetes clinic appointments.
|
|---|---|---|
|
Social circumstances
Domestic violence
|
1.4%
1/74 • Number of events 1 • 1 year, 6 months
|
0.00%
0/75 • 1 year, 6 months
|
|
Endocrine disorders
New Diabetes-Related Health Problem
|
12.2%
9/74 • Number of events 9 • 1 year, 6 months
|
6.7%
5/75 • Number of events 5 • 1 year, 6 months
|
|
Surgical and medical procedures
New Non-diabetes-Related Health Problem
|
21.6%
16/74 • Number of events 21 • 1 year, 6 months
|
10.7%
8/75 • Number of events 12 • 1 year, 6 months
|
|
Social circumstances
Problem with Parent-Child Relations
|
1.4%
1/74 • Number of events 1 • 1 year, 6 months
|
4.0%
3/75 • Number of events 3 • 1 year, 6 months
|
|
Psychiatric disorders
Psychiatric Problem
|
5.4%
4/74 • Number of events 4 • 1 year, 6 months
|
5.3%
4/75 • Number of events 4 • 1 year, 6 months
|
|
Social circumstances
School Related Problem
|
5.4%
4/74 • Number of events 4 • 1 year, 6 months
|
1.3%
1/75 • Number of events 1 • 1 year, 6 months
|
|
Endocrine disorders
Worsening Diabetes-Related Health Problem
|
9.5%
7/74 • Number of events 7 • 1 year, 6 months
|
8.0%
6/75 • Number of events 7 • 1 year, 6 months
|
|
Social circumstances
New Family Problem
|
0.00%
0/74 • 1 year, 6 months
|
1.3%
1/75 • Number of events 1 • 1 year, 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place