Trial Outcomes & Findings for Tailored Diabetes Self-Management Resources (NCT NCT02024750)
NCT ID: NCT02024750
Last Updated: 2019-09-18
Results Overview
Mean change in A1c per month (slope), during and post-intervention.
COMPLETED
NA
214 participants
Up to 5 time points during the intervention (12 months) and up to 4 time points in the post-intervention period (12 months)
2019-09-18
Participant Flow
Participant milestones
| Measure |
Tailored Resources
Four 75-minute group-based self-management resource sessions, matched to self-management barriers identified by PRISM survey
|
Usual Care
Routine multidisciplinary diabetes care
|
|---|---|---|
|
Overall Study
STARTED
|
106
|
108
|
|
Overall Study
COMPLETED
|
104
|
107
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Tailored Resources
Four 75-minute group-based self-management resource sessions, matched to self-management barriers identified by PRISM survey
|
Usual Care
Routine multidisciplinary diabetes care
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Tailored Diabetes Self-Management Resources
Baseline characteristics by cohort
| Measure |
Tailored Resources
n=106 Participants
Four 75-minute group-based self-management resource sessions, matched to self-management barriers identified by PRISM survey
|
Usual Care
n=108 Participants
Routine multidisciplinary diabetes care
|
Total
n=214 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
8-12 years old
|
47 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Age, Customized
13-16 years old
|
59 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Non-Hispanic, White
|
87 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Not non-Hispanic, White
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Clinical Site
Site 1
|
49 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Clinical Site
Site 2
|
57 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Relationship to child: Mother
|
84 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Insulin pump use
|
62 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Baseline A1c
|
8.9 Percent A1c
STANDARD_DEVIATION 1.5 • n=5 Participants
|
9.3 Percent A1c
STANDARD_DEVIATION 1.7 • n=7 Participants
|
9.1 Percent A1c
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Baseline Child Quality of Life (QOL)
|
66.7 units on a scale
STANDARD_DEVIATION 13.7 • n=5 Participants
|
66.0 units on a scale
STANDARD_DEVIATION 11.6 • n=7 Participants
|
66.3 units on a scale
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Baseline Parent Quality of Life (QOL)
|
62.1 units on a scale
STANDARD_DEVIATION 15.1 • n=5 Participants
|
60.4 units on a scale
STANDARD_DEVIATION 16.5 • n=7 Participants
|
61.2 units on a scale
STANDARD_DEVIATION 15.8 • n=5 Participants
|
|
Baseline Parent Fear of Hypoglycemia (FOH)
|
38.0 units on a scale
STANDARD_DEVIATION 9.6 • n=5 Participants
|
39.6 units on a scale
STANDARD_DEVIATION 10.3 • n=7 Participants
|
38.8 units on a scale
STANDARD_DEVIATION 9.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 time points during the intervention (12 months) and up to 4 time points in the post-intervention period (12 months)Population: 214 participants were analyzed for up to 5 time points during the intervention and up to 4 time points in the post-intervention period. Models include data to the point of withdrawal for 3 families.
Mean change in A1c per month (slope), during and post-intervention.
Outcome measures
| Measure |
Usual Care
n=784 HbA1c Observations
Participants who received usual care.
|
Tailored Resources
n=798 HbA1c Observations
Participants who received tailored resources.
|
|---|---|---|
|
Change in Hemoglobin A1c for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention
During Intervention
|
0.014 Percent HbA1c per month
Standard Error 0.009
|
0.018 Percent HbA1c per month
Standard Error 0.009
|
|
Change in Hemoglobin A1c for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention
Post-Intervention
|
0.035 Percent HbA1c per month
Standard Error 0.008
|
0.025 Percent HbA1c per month
Standard Error 0.008
|
PRIMARY outcome
Timeframe: Up to 2 time points during the intervention (12 months) and up to 3 time points in the post-intervention period (12 months)Population: 214 participants were analyzed for up to 2 time points during the intervention and up to 3 time points in the post-intervention period. Models include data to the point of withdrawal for 3 families.
Mean change in child quality of life per month (slope), during and post-intervention. Child quality of life is measured by the PedsQL Diabetes Module. Possible scores range from 0 to 100 with higher scores indicating better quality of life. Positive slopes reflect improving quality of life.
Outcome measures
| Measure |
Usual Care
n=481 Quality of Life Measures
Participants who received usual care.
|
Tailored Resources
n=470 Quality of Life Measures
Participants who received tailored resources.
|
|---|---|---|
|
Change in Child Quality of Life (QOL) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention
During Intervention
|
0.194 QOL scores per month
Standard Error 0.096
|
0.217 QOL scores per month
Standard Error 0.100
|
|
Change in Child Quality of Life (QOL) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention
Post-Intervention
|
0.083 QOL scores per month
Standard Error 0.155
|
0.010 QOL scores per month
Standard Error 0.163
|
PRIMARY outcome
Timeframe: Up to 2 time points during the intervention (12 months) and up to 3 time points in the post-intervention period (12 months)Population: 214 parents were analyzed for up to 2 time points during the intervention and up to 3 time points in the post-intervention period. Models include data to the point of withdrawal for 3 families.
Mean change in parent quality of life per month (slope), during and post-intervention. Parent quality of life is measured by the PedsQL Family Impact Module. Possible scores range from 0 to 100 with higher scores indicating better quality of life. Positive slopes reflect improving quality of life.
Outcome measures
| Measure |
Usual Care
n=480 Quality of Life Measures
Participants who received usual care.
|
Tailored Resources
n=478 Quality of Life Measures
Participants who received tailored resources.
|
|---|---|---|
|
Change in Parent Quality of Life (QOL) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention
During Intervention
|
0.115 QOL scores per month
Standard Error 0.097
|
0.078 QOL scores per month
Standard Error 0.100
|
|
Change in Parent Quality of Life (QOL) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention
Post-Intervention
|
0.182 QOL scores per month
Standard Error 0.161
|
0.172 QOL scores per month
Standard Error 0.168
|
SECONDARY outcome
Timeframe: Up to 2 time points during the intervention (12 months) and up to 2 time points in the post-intervention period (12 months)Population: 214 parents were analyzed for up to 2 time points during the intervention and up to 2 time points in the post-intervention period. Models include data to the point of withdrawal for 3 families.
Mean change in parent fear of hypoglycemia per month (slope), during and post-intervention. Parent fear of hypoglycemia is measured by the Hypoglycemia Fear Survey Worry Subscale. Possible scores range from 15 to 75 with higher scores indicating greater fear of hypoglycemia. Positive slopes reflect increasing fear of hypoglycemia.
Outcome measures
| Measure |
Usual Care
n=400 Fear of Hypoglycemia Measures
Participants who received usual care.
|
Tailored Resources
n=393 Fear of Hypoglycemia Measures
Participants who received tailored resources.
|
|---|---|---|
|
Change In Parent Fear of Hypoglycemia (FOH) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention
Post-Intervention
|
-0.074 FOH scores per month
Standard Error 0.132
|
-0.080 FOH scores per month
Standard Error 0.139
|
|
Change In Parent Fear of Hypoglycemia (FOH) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention
During Intervention
|
-0.088 FOH scores per month
Standard Error 0.089
|
0.046 FOH scores per month
Standard Error 0.093
|
Adverse Events
Tailored Resources
Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Elizabeth Cox
University of Wisconsin School of Medicine and Public Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place