- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03879642
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
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
|
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.
Collaborators
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
- 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.
- 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.
- 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.
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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