Trial Outcomes & Findings for MyDiaText Text Messaging Intervention for Diabetes (NCT NCT02927639)
NCT ID: NCT02927639
Last Updated: 2021-06-09
Results Overview
Estimate of self-management will be assessed via the Self-Care Inventory questionnaire. This scale measures self-reported adherence to diabetes self-care behaviors. A higher score on 1-5 scale is associated with more self care behaviors, i.e., better outcomes. The outcome was mean score on the scale. If a participant responded N/A, this question was not included in calculation of mean score.
COMPLETED
NA
166 participants
6 months
2021-06-09
Participant Flow
Participant milestones
| Measure |
Intervention
This group will receive the intervention for 6 months. The intervention will consist of daily text messages sent to the subject's personal mobile device in addition to the usual standard care. Subjects will be incentivized to respond to text messages via a financial reward lottery system. Previously developed text messages based on the ADA behavior goals will be used for this intervention.
MyDiaText: The intervention will consist of daily text messages sent to the subject's personal mobile device.
|
Control
This group will receive the usual standard of care for 6 months.
|
|---|---|---|
|
Overall Study
STARTED
|
83
|
82
|
|
Overall Study
COMPLETED
|
10
|
13
|
|
Overall Study
NOT COMPLETED
|
73
|
69
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MyDiaText Text Messaging Intervention for Diabetes
Baseline characteristics by cohort
| Measure |
Intervention
n=83 Participants
This group will receive the intervention for 6 months. The intervention will consist of daily text messages sent to the subject's personal mobile device in addition to the usual standard care. Subjects will be incentivized to respond to text messages via a financial reward lottery system. Previously developed text messages based on the ADA behavior goals will be used for this intervention.
MyDiaText: The intervention will consist of daily text messages sent to the subject's personal mobile device.
|
Control
n=82 Participants
This group will receive the usual standard of care for 6 months.
|
Total
n=165 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
83 Participants
n=99 Participants
|
82 Participants
n=107 Participants
|
165 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
15.8 years
STANDARD_DEVIATION 1.9 • n=99 Participants
|
15.5 years
STANDARD_DEVIATION 2.3 • n=107 Participants
|
15.6 years
STANDARD_DEVIATION 2.1 • n=206 Participants
|
|
Sex/Gender, Customized
Female
|
35 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Male
|
47 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Other
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
69 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
143 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
43 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
26 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
8 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
83 Participants
n=99 Participants
|
82 Participants
n=107 Participants
|
165 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Those analyzed were those who completed at least 1 self-care inventory survey. Analysis was preformed using multilevel mixed effects linear regression model. Outcomes are model-predicted.
Estimate of self-management will be assessed via the Self-Care Inventory questionnaire. This scale measures self-reported adherence to diabetes self-care behaviors. A higher score on 1-5 scale is associated with more self care behaviors, i.e., better outcomes. The outcome was mean score on the scale. If a participant responded N/A, this question was not included in calculation of mean score.
Outcome measures
| Measure |
Intervention
n=65 Participants
This group will receive the intervention for 6 months. The intervention will consist of daily text messages sent to the subject's personal mobile device in addition to the usual standard care. Subjects will be incentivized to respond to text messages via a financial reward lottery system. Previously developed text messages based on the ADA behavior goals will be used for this intervention.
MyDiaText: The intervention will consist of daily text messages sent to the subject's personal mobile device.
|
Control
n=70 Participants
This group will receive the usual standard of care for 6 months.
|
|---|---|---|
|
Change in Self-Care Inventory (SCI) Score From Baseline to 6 Months
|
3.57 score on a scale
Standard Error 0.07
|
3.62 score on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: 6 monthsHemoglobin A1c is a measure of glycemic control scale that reflects how well they followed recommendations for self-care during the past month (1="never do it" to 5 ="always do this as recommended, without fail"). Total scores range from 1-70 and previous data shows that youth with better self-care levels (higher scores) have significantly better glycemic control.
Outcome measures
Outcome data not reported
Adverse Events
Intervention
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place