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

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ClinicalTrials.gov Identifier: NCT03879642
Recruitment Status : Completed
First Posted : March 19, 2019
Results First Posted : January 14, 2022
Last Update Posted : January 25, 2022
Sponsor:
Collaborator:
Children's Mercy Hospital Kansas City
Information provided by (Responsible Party):
University of Kansas Medical Center

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

Condition or disease Intervention/treatment Phase
Parents Behavioral: REDCHiP Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized control pilot using a waitlist control group
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Reducing Hypoglycemia Fear in Parents of Young Kids Via Video-based Telemedicine
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Child Hemoglobin A1c [ Time Frame: absolute value at post-treatment (week 14) ]
    Child hemoglobin A1c- biological marker of glycemic control


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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No Contacts or Locations Provided
  Study Documents (Full-Text)

Documents provided by University of Kansas Medical Center:
Study Protocol and Statistical Analysis Plan  [PDF] October 12, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03879642    
Other Study ID Numbers: R21HD081502 ( U.S. NIH Grant/Contract )
First Posted: March 19, 2019    Key Record Dates
Results First Posted: January 14, 2022
Last Update Posted: January 25, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases