Back to resultsReducing Hypoglycemia Fear in Parents of Young Children With Type 1 Diabetes (REDCHiP)
Primary Purpose
Parents
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
REDCHiP
Sponsored by
About this trial
This is an interventional prevention trial for Parents
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
REDCHiP
Waitlist
Arm Description
10 week video-based telemedicine intervention to reduce parents hypoglycemia fear
10 week no intervention to provide waitlist control condition
Outcomes
Primary Outcome Measures
Hypoglycemia Fear Survey
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
Child Hemoglobin A1c
Child hemoglobin A1c- biological marker of glycemic control
Full Information
NCT ID
NCT03879642
First Posted
March 11, 2019
Last Updated
January 18, 2022
Sponsor
University of Kansas Medical Center
Collaborators
Children's Mercy Hospital Kansas City
1. Study Identification
Unique Protocol Identification Number
NCT03879642
Brief Title
Reducing Hypoglycemia Fear in Parents of Young Children With Type 1 Diabetes
Acronym
REDCHiP
Official Title
Reducing Hypoglycemia Fear in Parents of Young Kids Via Video-based Telemedicine
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
March 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
Children's Mercy Hospital Kansas City
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parents
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized control pilot using a waitlist control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
REDCHiP
Arm Type
Experimental
Arm Description
10 week video-based telemedicine intervention to reduce parents hypoglycemia fear
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
10 week no intervention to provide waitlist control condition
Intervention Type
Behavioral
Intervention Name(s)
REDCHiP
Intervention Description
10 week video-based telemedicine intervention to reduce hypoglycemia fear
Primary Outcome Measure Information:
Title
Hypoglycemia Fear Survey
Description
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.
Time Frame
absolute value at post-treatment (week 14)
Secondary Outcome Measure Information:
Title
Child Hemoglobin A1c
Description
Child hemoglobin A1c- biological marker of glycemic control
Time Frame
absolute value at post-treatment (week 14)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35045389
Citation
Patton SR, Monzon AD, Noser AE, Clements MA. Physical Activity, Glycemic Variability, and Parental Hypoglycemia Fear in Preschoolers With Type 1 Diabetes. Pediatr Exerc Sci. 2022 Jan 19;34(3):135-140. doi: 10.1123/pes.2021-0046. Print 2022 Aug 1.
Results Reference
derived
PubMed Identifier
31610073
Citation
Patton SR, Clements MA, Marker AM, Nelson EL. Intervention to reduce hypoglycemia fear in parents of young kids using video-based telehealth (REDCHiP). Pediatr Diabetes. 2020 Feb;21(1):112-119. doi: 10.1111/pedi.12934. Epub 2019 Nov 3.
Results Reference
derived
PubMed Identifier
31517512
Citation
Marker AM, Monzon AD, Nelson EL, Clements MA, Patton SR. An Intervention to Reduce Hypoglycemia Fear in Parents of Young Kids with Type 1 Diabetes Through Video-Based Telemedicine (REDCHiP): Trial Design, Feasibility, and Acceptability. Diabetes Technol Ther. 2020 Jan;22(1):25-33. doi: 10.1089/dia.2019.0244. Epub 2019 Nov 13.
Results Reference
derived
Learn more about this trial
Reducing Hypoglycemia Fear in Parents of Young Children With Type 1 Diabetes
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