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

Not Applicable

Completed

• Conditions: Parents
• Interventions: Behavioral: REDCHiP

• Registration Number: NCT03879642
• Lead Sponsor: University of Kansas Medical Center

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.

Study Timeline

• Study Start: 2015-10-01
• Primary Completion: 2018-10-01
• Study Completion: 2019-03
• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-19
• Results First Submitted: 2021-10-14
• Results First Submitted QC: 2021-12-16
• Status Verified: 2022-01
• Results First Posted: 2022-01-14
• Last Update Submitted: 2022-01-18
• Last Update Posted: 2022-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REDCHiP	REDCHiP	10 week video-based telemedicine intervention to reduce parents hypoglycemia fear

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Child Hemoglobin A1c	absolute value at post-treatment (week 14)	Child hemoglobin A1c- biological marker of glycemic control