Trial Outcomes & Findings for Reducing Hypoglycemia Fear in Parents of Young Children With Type 1 Diabetes (NCT NCT03879642)
NCT ID: NCT03879642
Last Updated: 2022-01-25
Results Overview
Hypoglycemia Fear Survey-Parents of Young Children. This is a measure of parents' perceived hypoglycemia fear. Higher scores suggest greater fear (worse outcome). Total possible range: 26-130.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
43 participants
Primary outcome timeframe
absolute value at post-treatment (week 14)
Results posted on
2022-01-25
Participant Flow
recruitment in clinic and by telephone
the study over-recruited the original study protocol by 3 parents; pre-assignment, parents completed baseline assessment measures;
Participant milestones
| Measure |
REDCHiP
10 week video-based telemedicine intervention to reduce parents hypoglycemia fear
REDCHiP: 10 week video-based telemedicine intervention to reduce hypoglycemia fear
|
Waitlist
10 week no intervention to provide waitlist control condition
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
21
|
|
Overall Study
COMPLETED
|
19
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
one parent from each condition did not complete all the baseline assessment measures
Baseline characteristics by cohort
| Measure |
REDCHiP
n=22 Participants
10 week video-based telemedicine intervention to reduce parents hypoglycemia fear
REDCHiP: 10 week video-based telemedicine intervention to reduce hypoglycemia fear
|
Waitlist
n=21 Participants
10 week no intervention to provide waitlist control condition
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=43 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=22 Participants
|
21 Participants
n=21 Participants
|
43 Participants
n=43 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=43 Participants
|
|
Age, Continuous
|
33.81 years
STANDARD_DEVIATION 4.59 • n=21 Participants • one parent from each condition did not complete all the baseline assessment measures
|
36.75 years
STANDARD_DEVIATION 5.02 • n=20 Participants • one parent from each condition did not complete all the baseline assessment measures
|
36.0 years
STANDARD_DEVIATION 4.9 • n=41 Participants • one parent from each condition did not complete all the baseline assessment measures
|
|
Sex: Female, Male
Female
|
21 Participants
n=21 Participants • one parent from each condition did not complete all baseline assessments
|
19 Participants
n=20 Participants • one parent from each condition did not complete all baseline assessments
|
40 Participants
n=41 Participants • one parent from each condition did not complete all baseline assessments
|
|
Sex: Female, Male
Male
|
0 Participants
n=21 Participants • one parent from each condition did not complete all baseline assessments
|
1 Participants
n=20 Participants • one parent from each condition did not complete all baseline assessments
|
1 Participants
n=41 Participants • one parent from each condition did not complete all baseline assessments
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=22 Participants • one parent in the waitlist control group did not complete this survey
|
1 Participants
n=20 Participants • one parent in the waitlist control group did not complete this survey
|
2 Participants
n=42 Participants • one parent in the waitlist control group did not complete this survey
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=22 Participants • one parent in the waitlist control group did not complete this survey
|
17 Participants
n=20 Participants • one parent in the waitlist control group did not complete this survey
|
38 Participants
n=42 Participants • one parent in the waitlist control group did not complete this survey
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=22 Participants • one parent in the waitlist control group did not complete this survey
|
2 Participants
n=20 Participants • one parent in the waitlist control group did not complete this survey
|
2 Participants
n=42 Participants • one parent in the waitlist control group did not complete this survey
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=43 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=43 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=43 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=22 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=43 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=22 Participants
|
19 Participants
n=21 Participants
|
40 Participants
n=43 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=43 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=22 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=43 Participants
|
PRIMARY outcome
Timeframe: absolute value at post-treatment (week 14)Population: 43 parents enrolled and were randomized; 36 parents completed the treatment. Therefore number analyzed reflects 36 parents who completed treatment.
Hypoglycemia Fear Survey-Parents of Young Children. This is a measure of parents' perceived hypoglycemia fear. Higher scores suggest greater fear (worse outcome). Total possible range: 26-130.
Outcome measures
| Measure |
REDCHiP
n=18 Participants
10 week video-based telemedicine intervention to reduce parents hypoglycemia fear
REDCHiP: 10 week video-based telemedicine intervention to reduce hypoglycemia fear
|
Waitlist
n=18 Participants
10 week no intervention to provide waitlist control condition
|
|---|---|---|
|
Hypoglycemia Fear Survey
|
75.94 units on a scale
Standard Deviation 18.46
|
70.78 units on a scale
Standard Deviation 14.93
|
SECONDARY outcome
Timeframe: absolute value at post-treatment (week 14)Population: 43 parents enrolled and were randomized; 36 parents completed the treatment. Therefore number analyzed reflects 36 parents who completed treatment.
Child hemoglobin A1c- biological marker of glycemic control
Outcome measures
| Measure |
REDCHiP
n=18 Participants
10 week video-based telemedicine intervention to reduce parents hypoglycemia fear
REDCHiP: 10 week video-based telemedicine intervention to reduce hypoglycemia fear
|
Waitlist
n=18 Participants
10 week no intervention to provide waitlist control condition
|
|---|---|---|
|
Child Hemoglobin A1c
|
8.07 percentage of glycated hemoglobin cells
Standard Deviation 1.30
|
7.97 percentage of glycated hemoglobin cells
Standard Deviation 0.80
|
Adverse Events
REDCHiP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Susana Patton
Nemours Children's Health-Jacksonville
Phone: 904-697-2000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place