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NCT03914547 · ClinicalTrials.gov registry record · NA
Home Video-based Telemedicine to Reduce Hypoglycemia Fear in Parents of Young Children
A NA study of Type 1 Diabetes Mellitus, sponsored by Nemours Children's Clinic.
- Active
- Registry status
- NA
- Development phase
- 396
- Enrollment target
- 2
- Study locations
NCT03914547: Active NA study of Type 1 Diabetes Mellitus, sponsored by Nemours Children's Clinic.
NCT03914547 is a NA study of Type 1 Diabetes Mellitus that is active but no longer recruiting, run by Nemours Children's Clinic. The registered enrollment target is 396 participants, above the 169-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (134% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03914547, a NA study of Type 1 Diabetes Mellitus, is active but no longer recruiting, sponsored by Nemours Children's Clinic.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 396 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Child glycemic control will be measured by change in hemoglobin A1c (HbA1c) NGSP (%) between baseline and post-treatment.
Conditions Studied
Interventions
- BEHAVIORAL REDCHiP
- BEHAVIORAL ATTN
Study Locations (2)
Florida
- University of Florida - Gainesville
Missouri
- The Children's Mercy Hospital - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 396 participants |
| Start Date | 2019-10-15 |
| Est. Completion | 2026-03-31 |
| Phase | NA |
What the registry record for NCT03914547 still lists
NCT03914547 is an interventional study that assigns participants to a tested intervention. The registered 396 participants enrollment target is mid-sized for trials with a published cap, above the 169-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (134% higher).
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which REDCHiP is the first listed.
NCT03914547 reports a single indexed study location in Florida, Missouri.
Frequently Asked Questions
What is clinical trial NCT03914547 about?
NCT03914547 is a clinical study titled "Home Video-based Telemedicine to Reduce Hypoglycemia Fear in Parents of Young Children". 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 objec...
What is the current status of trial NCT03914547?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 396 participants. The study started on 2019-10-15. Estimated completion is 2026-03-31.
What conditions does trial NCT03914547 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT03914547?
The interventions under investigation include: REDCHiP (BEHAVIORAL), ATTN (BEHAVIORAL).
Who is sponsoring clinical trial NCT03914547?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03914547 being conducted?
This trial has 2 study locations across Florida, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03914547's enrollment target sits among peer trials
396 12th of 112 higher than 101 of 112 other Type 1 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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