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

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

Sponsors

Lead Sponsor: University of Kansas Medical Center

Collaborator: Children's Mercy Hospital Kansas City

Source 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.

Overall Status Completed
Start Date October 1, 2015
Completion Date March 2019
Primary Completion Date October 1, 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Hypoglycemia Fear Survey change from baseline to post-treatment (week 14)
Secondary Outcome
Measure Time Frame
Child hemoglobin A1c change from baseline to post-treatment (week 14)
Enrollment 43
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: REDCHiP

Description: 10 week video-based telemedicine intervention to reduce hypoglycemia fear

Arm Group Label: REDCHiP

Eligibility

Criteria:

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

Gender: All

Minimum Age: 1 Year

Maximum Age: 6 Years

Healthy Volunteers: No

Verification Date

March 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: REDCHiP

Type: Experimental

Description: 10 week video-based telemedicine intervention to reduce parents hypoglycemia fear

Label: Waitlist

Type: No Intervention

Description: 10 week no intervention to provide waitlist control condition

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: randomized control pilot using a waitlist control group

Primary Purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov