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

January 18, 2022 updated by: University of Kansas Medical Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: REDCHiP
10 week video-based telemedicine intervention to reduce parents hypoglycemia fear
Behavioral: REDCHiP
10 week video-based telemedicine intervention to reduce hypoglycemia fear
No Intervention: Waitlist
10 week no intervention to provide waitlist control condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
absolute value at post-treatment (week 14)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child Hemoglobin A1c
Time Frame: absolute value at post-treatment (week 14)
Child hemoglobin A1c- biological marker of glycemic control
absolute value at post-treatment (week 14)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

Children's Mercy Hospital Kansas City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

March 13, 2019

First Posted (Actual)

March 19, 2019

Study Record Updates

Last Update Posted (Actual)

January 25, 2022

Last Update Submitted That Met QC Criteria

January 18, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21HD081502 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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