Reducing Hypoglycemia Fear in Parents of Young Children With Type 1 Diabetes

Parents Clinical Trial

— REDCHiP  

Official title:

Reducing Hypoglycemia Fear in Parents of Young Kids Via Video-based Telemedicine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03879642
• Other study ID #: R21HD081502
• Status: Completed
• Phase: N/A
• Start date: October 1, 2015
• Est. completion date: March 2019

Study information

• Verified date: January 2022
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pilot of a novel video-based telemedicine intervention to reduce fear of hypoglycemia in parents of young children with type 1 diabetes.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: March 2019
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoglycemia
• Parents

Intervention

Behavioral:
• REDCHiP
10 week video-based telemedicine intervention to reduce hypoglycemia fear

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Children's Mercy Hospital Kansas City

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	absolute value at post-treatment (week 14)
Secondary	Child Hemoglobin A1c	Child hemoglobin A1c- biological marker of glycemic control	absolute value at post-treatment (week 14)