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Completed

NCT Number: NCT03879642

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

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

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Key information

Conditions

Parents

Age range

1 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

REDCHiP

Behavioral

10 week video-based telemedicine intervention to reduce hypoglycemia fear

Primary outcomes

  1. Hypoglycemia Fear Survey

    Time frame: 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 outcomes

  1. Child Hemoglobin A1c

    Time frame: absolute value at post-treatment (week 14)

    Child hemoglobin A1c- biological marker of glycemic control

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • Children's Mercy Hospital Kansas City

Registry information

Official study title

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

Acronym: REDCHiP

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Mar 19, 2019
Registry last updated
Jan 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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