Home Video-based Telemedicine to Reduce Hypoglycemia Fear in Parents of Young Children
REDCHiP
2 other identifiers
interventional
396
1 country
2
Brief Summary
Investigators developed REDCHiP (Reducing Emotional Distress for Childhood Hypoglycemia in Parents), an innovative video-based telemedicine intervention. In the pilot work, investigators found preliminary efficacy for REDCHiP in reducing parental FH, parenting stress, and children's HbA1c. The objective of this clinical trial is to conduct a randomized clinical trial (RCT) comparing REDCHiP to a relevant attention control intervention (ATTN) in families of young children, thereby continuing to establish its efficacy. The proposed R01 aims are: 1) To evaluate whether parents who receive REDCHiP report reductions in FH and parenting stress at post-treatment compared to parents who receive the ATTN; 2) To evaluate whether children of parents who receive REDCHiP have a lower HbA1c and less glycemic variability at post-treatment compared to children of parents who receive ATTN; 3) To examine whether families who receive REDCHiP maintain reductions in FH, parenting stress, and child HbA1c at a 3-month followup compared to families who receive ATTN.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2019
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2019
CompletedFirst Posted
Study publicly available on registry
April 16, 2019
CompletedStudy Start
First participant enrolled
October 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedJune 5, 2025
June 1, 2025
5.6 years
April 11, 2019
June 2, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Child Glycemic Control
Child glycemic control will be measured by change in hemoglobin A1c (HbA1c) NGSP (%) between baseline and post-treatment.
change from baseline to post-treatment (week 14)
Parents Hypoglycemia Fear
Parental fear will be measured by the Hypoglycemia Fear Survey - Parents of Young Children (HFS-PYC), a 26-item survey with a score range of 26-130. Higher scores indicate a higher fear rating.
change from baseline to post-treatment (week 14)
Study Arms (2)
REDCHiP intervention arm
EXPERIMENTALREDCHiP uses 10- video-based telemedicine sessions to deliver T1D education, behavioral parent training, and problem-solving to enhance parents' knowledge and skills. Sessions last about 45-60 minutes each.
Attention Control arm
ACTIVE COMPARATORATTN uses 10- video-based telemedicine sessions to deliver general patient education specific to young children. Similar to REDCHiP, all ATTN sessions last 45-60 minutes.
Interventions
REDCHiP includes 10 telehealth sessions. REDCHiP uses a three-pronged approach to reduce parents' FH. It uses T1D education and problem-solving to enhance parents' knowledge and skills. It uses child age-appropriate behavioral parent training to promote parents' skills and confidence in managing disruptive child behaviors and reducing their reliance on hypoglycemia avoidance behaviors. It uses cognitive-behavioral therapy strategies to help parents reduce maladaptive thinking/coping related to hypoglycemia fear.
Provides a similar attention control. ATTN includes 10 telehealth sessions.
Eligibility Criteria
You may qualify if:
- Child age between 2-6.99 years
- Type 1 diabetes diagnosis ≥6 months
- Child is on an intensive insulin regimen (pump or multiple daily injection)
You may not qualify if:
- Parents of children on a conventional regimen
- Children who have an allergy or sensitivity to the adhesive and/or skin preparation used for continuous glucose monitoring
- Children with a comorbid chronic condition (e.g., renal disease)
- Parents who do not speak English.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nemours Children's Cliniclead
- Children's Mercy Hospital Kansas Citycollaborator
- University of Floridacollaborator
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)collaborator
Study Sites (2)
University of Florida
Gainesville, Florida, 32611, United States
The Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Related Publications (1)
Patton SR, McConville A, Marker AM, Monzon AD, Driscoll KA, Clements MA. Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP): Protocol for a Randomized Clinical Trial to Test a Video-Based Telehealth Intervention. JMIR Res Protoc. 2020 Aug 18;9(8):e17877. doi: 10.2196/17877.
PMID: 32808936DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Research Scientist
Study Record Dates
First Submitted
April 11, 2019
First Posted
April 16, 2019
Study Start
October 15, 2019
Primary Completion
June 1, 2025
Study Completion
March 31, 2026
Last Updated
June 5, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share
no plan to share individual participant data; de-identified group data may be available to qualified researchers upon request to the principal investigator