Parents
Conditions
Brief summary
Pilot of a novel video-based telemedicine intervention to reduce fear of hypoglycemia in parents of young children with type 1 diabetes.
Detailed description
This was a two group randomized controlled study using a wait-list control design. All participating parents had the opportunity to receive 10 video-based telemedicine sessions administered over 13 weeks. Study assessments took place at baseline, post-treatment, and 3 month followup. Study outcomes included parent reported hypoglycemia fear, parenting stress, diabetes distress, and child glycated hemoglobin.
Interventions
BEHAVIORALREDCHiP
10 week video-based telemedicine intervention to reduce hypoglycemia fear
Sponsors
Children's Mercy Hospital Kansas City
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
randomized control pilot using a waitlist control group
Eligibility
Sex/Gender
ALL
Age
1 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* Parents of children, between 1-6 years old, with type 1 diabetes for at least 6 months, on either multiple daily injections or an insulin pump, and parents speak English
Exclusion criteria
* Families of children who are older than 6 years-old and or do not have type 1 diabetes; children follow a conventional insulin regimen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemia Fear Survey | absolute value at post-treatment (week 14) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child Hemoglobin A1c | absolute value at post-treatment (week 14) | Child hemoglobin A1c- biological marker of glycemic control |
Participant flow
Recruitment details
recruitment in clinic and by telephone
Pre-assignment details
the study over-recruited the original study protocol by 3 parents; pre-assignment, parents completed baseline assessment measures;
Participants by arm
| Arm | Count |
|---|---|
| REDCHiP 10 week video-based telemedicine intervention to reduce parents hypoglycemia fear
REDCHiP: 10 week video-based telemedicine intervention to reduce hypoglycemia fear | 22 |
| Waitlist 10 week no intervention to provide waitlist control condition | 21 |
| Total | 43 |
Baseline characteristics
| Characteristic | REDCHiP | Waitlist | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 21 Participants | 43 Participants |
| Age, Continuous | 33.81 years STANDARD_DEVIATION 4.59 | 36.75 years STANDARD_DEVIATION 5.02 | 36.0 years STANDARD_DEVIATION 4.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 17 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 21 Participants | 19 Participants | 40 Participants |
| Sex: Female, Male Female | 21 Participants | 19 Participants | 40 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 21 |
| other Total, other adverse events | 0 / 22 | 0 / 21 |
| serious Total, serious adverse events | 0 / 22 | 0 / 21 |
Outcome results
Primary
Hypoglycemia Fear Survey
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REDCHiP | Hypoglycemia Fear Survey | 75.94 units on a scale | Standard Deviation 18.46 |
| Waitlist | Hypoglycemia Fear Survey | 70.78 units on a scale | Standard Deviation 14.93 |
ANOVA
Secondary
Child Hemoglobin A1c
Child hemoglobin A1c- biological marker of glycemic control
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REDCHiP | Child Hemoglobin A1c | 8.07 percentage of glycated hemoglobin cells | Standard Deviation 1.3 |
| Waitlist | Child Hemoglobin A1c | 7.97 percentage of glycated hemoglobin cells | Standard Deviation 0.8 |
repeated measures ANOVA