Home Video-based Telemedicine to Reduce Hypoglycemia Fear in Parents of Young Children
Completed · Not applicable
Conditions studied: Type 1 Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT03914547
- Run by
- Nemours Children's Clinic
- People needed
- 396
- Starts
- 2019-10-15
- Expected to finish
- 2026-03-31
- Last updated by the study team
- 2026-04-06
Who can join
Age: 2 and older, up to 6. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- University of Florida — Gainesville, Florida, United States
- The Children's Mercy Hospital — Kansas City, Missouri, United States
Full record on ClinicalTrials.gov
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